Every new RA arrives eager to get started, but first there are a number of hurdles to get over.

Activate your Partners User ID

You must do this step first.  Your Partners User ID will be needed to access your email, log into PeopleSoft, and access the Partners network. Before you can activate this User ID, your paperwork from orientation must be processed by HR.  (It can take a few hours after orientation before your User ID is ready to be activated, so if you receive an error message you might need to wait.)

1. Go to https://myprofile.partners.org/ and select “New User”.
2. Select the option “click here for password self-service,” and fill in the form.
3. The system will issue your Partners User ID, which will look like your initials followed by a number (such as “dap47”).
4. You must choose a password and some challenge questions. Your password must be at least 8 characters long and have letters and numbers.

Verify your Partners email

1. Go to the web site partners.org/email and log in with your new user ID and password. If you can log in, your email is set up!  It could take 10 to 30 minutes after you activate your User ID for this to work.
2. Head’s up: Although you log in to email using your Partners User ID, your email username will be different. Usually it’s your first initial plus your last name (e.g. sfreud@partners.org).  The best way to find you email address might be to send an email to someone in the office then ask them who it’s from!  :-\

Request a mclean.harvard.edu email address

Initially you are issued an ‘@partners.org’ address, but you should set up an ‘@mclean.harvard.edu’ address.  Unless there is a specific reason to do otherwise, use your McLean email address for all correspondence.

1. Make a note of your partners.org address before you start. You’ll need to know it later.
2. To activate a McLean email address, call the IS Helpdesk at 617-726-5085 or submit an IS service request at http://helpdeskselfservice.partners.org/. Ask them to create a “mclean.harvard.edu” address for you, and to make it your primary email address (use the word ‘primary’ in your request).
3. When the McLean address gets set up, your default ‘From’ and ‘Reply-to’ name In Outlook will switch to be your mclean.harvard.edu address (within a few hours).
4. Head’s up: Technically your @mclean.harvard.edu address is an alias for your @partners.org address. An email message sent to either address goes to the same inbox.

Once you have your address set up, ask Dave to add you to the standard distribution lists for LATN, CDASR, and the MIC (the actual names are mcl-latn, mcl-cdasr, and mic-plus, respectively).

You’ll need to subscribe to the ‘McLean Research List’ yourself using the form at http://researchlistweb.partners.org/list/w/mcl-research/subscribemcl-research.html.

Set up Outlook on your PC

• To set up Outlook on your work PC, contact Dave
• Create a personal signature (a ‘sig’) that will be added to the end of your email
• We also have a shared mailbox for recruitment: neurolab@mclean.harvard.edu. You or one of the other RAs must contact the IS Helpdesk to request access to it.

LATN uses a server called “Jupiter” for all our files.  This includes all your personal work files , all study data, subject information, recruiting tools, IRB protocols and everything else LATN-related.  Jupiter is in the MIC data center and is managed by the MIC-IT team, which consists of Chrissy Bonello and Jesse Baer.

Your Jupiter account and password are totally independent from your Partners User ID and password.  It should have been set up for you before you arrived, but if you haven’t received the confirmation email you should let Dave know.

1. You’ll receive the email when your account is created, with instructions for how to access your account.
2. Your Jupiter account name will normally consist of your first initial and your last name. A password will be assigned for you, and you should change it as soon as you can.  Instructions for this should be included in the email your received, but the “Jupiter_Server_Setup_Instructions” document in  common/Admin/RA_Training_Modules folder has instructions for changing the password.
3. Those instructions also explain how to “Map a Network Drive” so you can access Jupiter easily from your PC or Mac.
4. You will have your own folder on Jupiter (your ‘’home” directory). You must keep all your work files in this folder, and not on your desktop PC or Mac, for two reasons.  First the files will be accessible from any other computer when you’re not in your office; and second, the files on your desktop will not be backed up, so you will lose them if anything happens to the computer.
5. You will also have access to certain shared directories based on your job and the projects you are working on. If you need additional access, contact Dave.

Security Requirement: Only you can use your account. Every lab member must have an individual account on Jupiter. You must use only your own account, and you must not share your account with anyone else.  If you are using a shared computer such as a countertop PC, you must map your network drives using your own account or else you won’t have access to the right directories. Then you must Log Off at the end of every Windows session to close your drive mappings properly, otherwise the next user can get access to your files.

You must complete the online Human Subject Protection training program, which is run by CITI, in order to work on any study. This is mandatory and must be completed before you can be added to the study staff for any project.  The training takes about 3 or 4 hours.

1. Before you can enroll you must have a Partners or McLean email address.
2. Go to https://www.citiprogram.org/ and click the Register button to create an account
   • Enter “Massachusetts General Hospital” as your institution
   • Provide your McLean email address, if it’s been set up, or you can use your partners.org address.
3. The next few screens determine which training you’ll need to take. (The interface changes occasionally, so the following instructions may be outdated. Ask for help on anything that’s not clear)
   • Indicate that you’ll be doing Human-Subjects research (not animals or IACUC), and that you will be involved in “DCR” (design, conduct, or reporting).
   • You should be assigned to take the “Good Clinical Practice” training. If you don’t see this, you should stop and find out what to do next.
   • Note: The training requirements changed in December 2016. Everyone must now take the GCP course, while the other courses are no longer required (e.g. Biomedical Research)
4. Complete all of the modules listed.
5. When you finish, download a PDF copy of your certification and email it to Dave, and let the RAs you’ll be working with know you’ve completed the training.
6. Within 24 hours, your status will be updated on the Insight system, which is the system the IRB uses to track all study protocols. When your status is updated on Insight, the other RAs can submit amendments to add you to the study staff.
7. When you’ve been added to a study, you will receive an email directing you back to Insight to confirm.

If you completed the relevant CITI training at another institution, you should be able to transfer it to Partners/McLean.  The instructions can be found on the FAQ here: https://partnershealthcare.sharepoint.com/sites/phrmportal/Lists/FAQs/CITI%20Training.aspx.

If you have any problems with the CITI process, send email to citiprogram@partners.org or contact the IRB help desk.  Further information about CITI administration and requirements can be found at https://partnershealthcare.sharepoint.com/sites/phrmResources/t/Pages/CITI-Program.aspx.

Most scheduling of people and resources within the department is done using Google calendars.  If you don’t have a Google calendar, follow these instructions from Google: https://support.google.com/calendar/answer/2465776?hl=en&ref_topic=3417969.  If you already have a personal Google calendar, you might prefer to keep it private. In this case, you can create a second Google calendar that’s just for lab appointments following these instructions: https://support.google.com/calendar/answer/37095?hl=en.

Share your calendar with all the other RAs, giving them the ability to ‘Make Changes’ and everyone will do the same for you.  Ask one of the RAs or Dave will also give you access to the calendars for the other lab resources such as the laptops, the various interview rooms, and the EEG system.  To schedule a resource, you simply create an appointment on those calendars.  Include your name and extension so others can contact you if a scheduling conflict arises.

How to Dial at McLean

• To call someone within McLean, dial the four-digit extension.
• To call numbers in the 617 area code, dial 9-1 and then the number. So to reach Mike’s Pizza in Belmont, dial 9-1-617-484-0130.
• To call to any other area code, dial the access code 165986 first, then 9, then 1 and the number. So to reach Patsy’s Pizza in New York City, dial 165986-9-1-212-534-9783.
• To call in to the hospital, dial 617-855- and the extension. For example to call Diego’s office from your cell phone, dial 617-855-4230.
• The main number at McLean is 617-855-2000. If you don’t know the extension of the person you’re trying to reach, call the main number. From inside the hospital, dial “0” to reach the switchboard.

Voicemail Set-Up

• Usually a new RA inherits an extension from a previous RA. If you’re inheriting a phone, you need to clear the previous owner’s voicemail and password.  Contact Communications Services (x2113).
• Use the “Message” button on your phone to access voicemail, or dial x3660 from any phone.
• Enter your 6-digit voicemail password. The default password for new voicemail accounts is “mclean” (325326 #)
• Once connected, press #4 for Personal Options
  • For Greetings, press #3. Then
  • Change personal greeting – press #1
  • Change recorded name – press #3
  • Follow directions accordingly.

Accessing your voicemail

There are three ways you can access your voicemail.

• From your desk, your phone has a button labeled “Message” that connects directly to your voicemail
• From inside the hospital, dial x3660 to connect to the voicemail system.
• From outside the hospital, access the voicemail system at 617-855-3660.

Note: McLean’s Caller-ID is Blocked

• When you call a number outside the hospital, the caller ID is blocked. The recipient just sees “Unavailable” or “Caller ID Blocked” displayed on their phone when you call.
• Sometimes people can’t or won’t answer blocked calls, including some subjects or candidates you’re trying to reach. If you know this will be a problem, there is a special access code, 165555, to be used instead of 165986.  However, don’t use this unless it’s necessary because calls using this access code are audited every month.

Paging within Partners

To page someone, dial 0 on a work phone and then give the name of the person who should be paged.

There are a number of training sessions you’ll need to attend, so you should work with the other RAs to schedule them as soon as they are available.

MRI Safety Training

All RAs need to complete the Imaging Center’s MRI Safety training, and pass the test. This will allow you to enter to the scanner rooms to help with setting participants up in the scanner. If you have not completed the training yet, you can still observe MRIs from the control room.

• Bob Baden is in charge of MRI Safety Training. Contact him (x3321, rbaden@partners.org) and let him know you are a new RA who needs to be MRI safety certified.
• Note that you will also need to contact him to set up your CPR/AED training (see below), so consider sending him one single email with both of these requests.
• He should contact you to pick up the safety training binder and fill out a request form, not necessarily in that order. Consult with another RA before filling in the request form to make sure you are being given suitable permissions.
• He will also set a date for you to watch the MRI safety video and take the test afterwards. Do not pick a date that will not give you enough time to prepare for the test, although it is not overly challenging.
• If you pass the test, you will be contacted and informed that your badge can now be used to enter the MIC and the scanning suites. If you fail you will need to set another date to take the test again.

eBuy Training

You will use E-Buy quite frequently to purchase items for the lab,

• You may do the eBuy training online, BUT attending the class seminars will teach you the tips and tricks (especially because they’ll teach you how to avoid the bugs in the system)
• To schedule attendance at an in-class seminar, click on “eBuy Hands-On Classroom Training Dates”
• Click on “McLean Hospital” and follow the directions OR
• Email ebuy@partners.org with the following information and request dates and times for the next training. Training is usually 2 hours.
• NOTE: You must fax in a form signed by your supervisor and have taken a class prior to contacting PHS Accounts Payable about adding Financial Productions to your PeopleSoft account.

eCheck and e-Expenses Training

You will use the eCheck system to send compensation checks to participants, and the e-Expenses system to submit expense reports.

• This training is held regularly at McLean. McLean staff should receive emails about upcoming trainings that you can sign up for, but you can also contact Cathy O’Connell (x2637; cmoconnell@partners.org) directly to ask about upcoming trainings and register.

HealthStream

McLean has a set of core training modules that every employee must complete, covering topics such as fire safety, infection control, and HIPAA compliance.  These are available online through the HealthStream system, at http://partners.org/healthstream. New employees should complete this training within their first 30 days.

• To sign up on the HealthStream website, use your Partners User ID and the default password “abc123”. You will change your password after logging in.

CPR/AED Training

All employees must take a standard course on CPR/AED first aid. This is not an immediate requirement to be allowed on campus, but you should sign up for this training ASAP as soon as it is offered. Courses are not always regularly offered and may be difficult to get into.

• Contact Bob Baden at the MIC (x3321, rbaden@partners.org) and let him know you’d like to sign up for the next CPR/AED training session.
• You must take a refresher course every two years.

PET Training

All RAs who run PET studies must attend a short Radiation Safety seminar at MGH, whether their study is at the MGH main campus or the Martinos Center. Briefings are usually given by Tara Medich (tmedich@partners.org), and you can contact Paula Lyons (617-726-2425, plyons2@partners.org) to schedule an appointment. Additional information can be found here: http://www.partners.org/researchcores/radiation/radiation_mgh.asp

If the PET study is being run at the Martinos Center, you must also attend the MRI safety class offered there. Sessions are held approximately every two weeks, and are announced on their mailing lists.

IRB, Insight, and Regulatory Binder Training

Training for IRB requirements and procedures is typically done on-the-job when the need arises, by one of the more experienced RAs.  However the IRB web site has a tremendous amount of information that can help with specific situations: https://partnershealthcare.sharepoint.com/sites/phrmapply/aieipa/irb.

Insight (http://insight.partners.org) is a web-based application used for IRB protocol administration.  Insight training is usually done on-the-job, however online video training and quick reference guides are available at https://partnershealthcare.sharepoint.com/sites/phrmResources/t/Pages/InsighteIRB-Training.aspx.

Regulatory binders contain all of the documents related to a particular study, including the IRB documentation and much more. They are mandatory for any studies involving treatment, drugs, or radiation, and for studies sponsored by private industry, and we maintain them for every study in the lab.  It is important to keep them up to date.  The Partners QI Program provides information about regulatory binders on their website at https://partnershealthcare.sharepoint.com/sites/phrmdepartments/poc/qi.

About once a year, people from the IRB and the QI Program from Partners offer a seminar at McLean.  Contact Dave to find out when the next one is scheduled.

After you’ve caught up with the Day 1 tasks, you can move on to these less urgent activities.

HR and Benefits Updates on PeopleSoft

You will use the PeopleSoft-HR application to update your benefits enrollments, view your paycheck, update your vaccination history, and complete many other HR-related tasks.  At orientation, the HR representative reviews many tasks that you need to complete in the first few days of employment.

1. Access PeopleSoft at http://peoplesofthr.partners.org. Log in with your Partners User ID.
2. Click the menu item “HRMS Production” to access the HR functions.

Keys

You will need the following keys:

1. The key to your office
2. The KB3 key: Opens the doors to the CDASR area, EEG rooms, and Behavioral Testing Room
3. A key to your desk and the file cabinet in your office.

IMPORTANT: The main door into the CDASR office area gets locked at 5:00 PM every day. You must bring your KB3 key with you if you leave the area (to go to the restrooms, for instance).

In most cases a set of keys will be ready for you when you arrive, passed down from your predecessors. If not, keys have to be ordered using the Facilities Work Order form:  http://phsmclgpm2/GpmWoRequest.aspx. It takes at least a week or usually more to make keys.  When they’re ready, you will get a confirmation email from the Work Order system saying that the keys have been cut, and you can pick them up at the Security desk in AB1. If you don’t get a confirmation after a week, you can call security (x2121) to see if they are ready.

The other keys you will need are in the safe, in the EEG control room. This includes keys to additional interview rooms, keys to the filing cabinets in the corridor, and keys for rooms at the MIC.

At the MIC, the DD11 key opens the interview rooms, the MIC conference room, and many other common spaces.  The DC11 key opens the BPRL Exam Room (e.g. for processing inflammatory markers). Both of these keys are available in the safe. Orders for MIC keys must be approved by Terry Mancini, at the MIC.

Update your Partners Telephone Directory (PPD) Entry

The PPD (http://ppd.partners.org) is the ‘headwaters’ of personal data, including items like office location, telephone number, and position title.  This information flows into the Outlook/Exchange address book. Your PPD entry is initially created by HR, but within a few days you should review it and fill in any missing information.  To update it, click on the “Go To My Entry” link and follow the instructions.

Harvard Library Privileges

RAs will need to obtain a ‘Special Borrower Card’ from the Countway Library at Harvard Medical School.  This will provide you with online access to all the academic journals you will need to conduct literature searches or create bibliographies for lab research.  The application form and a description of the program are available on the Countway website at https://www.countway.harvard.edu/about/research-assistants.

A Harvard ID is only issued to people who have faculty appointments at Harvard Medical School, such as postdocs.  In the past, some RAs were given appointments but this is no longer a common practice (it now requires a letter from Scott Rauch justifying why the appointment is necessary).

For updated website information refer to the file “Useful Websites”  in the folder common\Admin\Center_Directory_and_McLean_Contacts

McLean Sites

• McLean Hospital Website          http://www.mcleanhospital.org/
• McLean Intranet “Brainwaves”:  https://mclean.partners.org  (the “s” is required in https:)

Partners Sites

During 2016, most Partners web sites were being redesigned to use SharePoint, and many of these URLs may be changing.  SharePoint sites rely on Office365 for security, and this frequently requires multiple logins and difficulties.

Office 365 Login

When an internal website prompts you with an Office 365 login screen, enter your email address and press OK.  A password is not required on that initial screen. You will be redirected to a standard Partners login page.

• Research Navigator                                https://partnershealthcare.sharepoint.com/sites/phrmportal
  • All of the central research organizations such as the IRB, Research Finance, and Research IS have moved their web sites into the Research Navigator portal. Part of it is a public side, accessible without logging in, and part is private that has all the useful information.
  • According to their web site: “Research Navigator is a consolidation of research content, resources, and administrative systems for Partners employees hosted on the Microsoft Office 365 cloud.”
• “PartnersPulse” Intranet                         http://pulse.partners.org
• “PPD” Partners Phone Directory            http://ppd.partners.org
• Supply Chain (formerly Materials Mgmt) http://supplychain.partners.org
• Research Computing                              http://rc.partners.org

IRB Sites

• Overview of IRB approval processes: https://partnershealthcare.sharepoint.com/sites/phrmApply/aieipa/irb
• IRB Policies:  https://partnershealthcare-public.sharepoint.com/Pages/Policy_and_Guidance.aspx
• QI Program (Reg Binder information): https://partnershealthcare.sharepoint.com/sites/phrmdepartments/poc/qi
• IRB Cede Review (to submit requests for one IRB to cede review to another): http://catalyst.harvard.edu/services/irbcede/

Partners Applications

• Insight:                          https://insight.partners.org/
• PeopleSoft:                   https://PeopleSoftportal.partners.org/public/
• Outlook Web App:         https://partners.org/email
• Facilities work orders:   http://phsmclgpm2/GpmWoRequest.aspx
  • Easier to remember:    http://bit.ly/mcl-workorder
• IT help request:             https://partnershealthcare.service-now.com/phsess/main.do
• Egencia:                        https://www.egencia.com

Study-Related Websites

• Calcium:                        https://calcium.mclean.harvard.edu/cgi-bin/Calcium40.pl?login
• RedCap:                        https://redcap.partners.org
• NIH Clinical Trials:          https://register.clinicaltrials.gov/
• Osirix repository:            https://mini2.mclean.harvard.edu:3333/
• MGH PET Calendar:      http://petmanager.mgh.harvard.edu/

CDASR websites

• Main website:                             http://cdasr.mclean.harvard.edu/
• LATN Recruiting homepage:      http://www.mcleanstudies.org/
• Recruitment survey (REDCap):  http://www.mcleanstudy.org/

For updated contact information refer to the file “Useful Contacts”  in the folder “common\Admin\Center_Directory_and_McLean_Contacts”.

CDASR Speaker Series

The CDASR speaker series generally begins in the fall and ends in June.  The series takes place on approximately every other Wednesday from 9:30-10:30 am in the Academic conference room in deMarneffe.

One of the RAs will be assigned to be the coordinator. Their responsibilities are:

• Review the program of speakers when Diego finalizes it (usually in August) and book the Academic conference room for every date.
• Before the event, the coordinator double-checks the room booking, orders catered food (tip: mini muffins sound good, but don’t taste as good as the big ones!), confirms with the speaker in advance, send an email announcing the seminar, and makes sure the projector works.
• See “common\Admin\SpeakerSeries\CDASR_Speaker_Series” for separate document with instructions and email templates. You can also find the catering order forms there.

Booking Conference Rooms

The BrainWaves page at https://mclean.partners.org/departments/administration/conferenceRooms.aspx provides most of the information you’ll need for most if not all conference rooms. Each room has an Outlook Calendar, where you can check availability.  The calendars are buried in the “Folders” section of Outlook:

Public folders > All Public Folders > Partners > McL > Conference Rooms

Hint: when you find the calendars you’re interested in, drag the icon to your “Favorites” folder so you don’t have to follow this path next time.

To book the Academic CR (room 218) or the Research CR (room 245), send your request to officeofcao@mclean.harvard.edu. Use this generic address, and either Laurie Sibilia or Caroline Rotundi will take care of. They can also help posting events on the McLean events calendar, and advertising it on the video displays in the cafeteria.

To book conference rooms in the Administration Building (e.g. Pierce Hall, Putnam Room, etc.), contact Mary Beth Traynor (x3581).

Media Services

Helpful info on booking rooms, requesting catering and room setup, A/V equipment, and recording, as well as the appropriate contacts for these services, can be found at: https://mclean.partners.org/departments/administration/conferenceRooms.aspx.

Catering

A sample catering order form can be found in common/Admin/SpeakerSeries. Fax to Dot at #2658 at least 48 hours in advance.  For events like prospective faculty talks, which may require fancy sandwiches (everyone loves these!!!), contact Colleen Sullivan (she’s very helpful and nice; csullivan34@partners.org, x3379 or 617-972-0789). The fancy sandwich menu can be found in common/Admin/SpeakerSeries.

Booking a Conference Call

You can either book a conference call online (this is the best option because it will send Diego a confirmation email and can be viewed/modified anytime) or by phone.

Booking a conference call online:

• Go to Verizon Manage My Meetings: https://e-meetings.verizonbusiness.com/global/en/login.php?langKey=en
• See passwords document (common\confidential\passwords) for login information
• Click tab “reserved audio calls”, then “add calls”
• Complete the forms
  • If the call has international participants, it needs to be “operator assisted”.
• Send Diego the call in number and passcode. He should also receive an automated email from Verizon with this information
• You should then be able to see the call and information (and make any changes if necessary) by going back to the “reserved audio calls” tab.

Booking a conference call by phone:

• Call MCI Conferencing at: 800-475-5000
• Choose option 1 (audio conferencing)
• Provide the operator with the following information:
  • Authorization code: 2160209
  • Name of the conference call leader
  • Type of call you want to have (premier, standard, or unattended)
  • Date, time, length of call
  • Number of participants on call
• They will then provide you with the call-in number and code. Make sure to circulate with Diego and others participating in the call!

Publicizing an Event

• Go to brainwaves for links to public affairs related issues: https://mclean.partners.org/departments/administration/businessDevelopmentMarketingPublicAffairs.aspx
• Adriana Bobinchock (x2171) is the director of Public Affairs and can send email announcements and post on BrainWaves to advertise events
• For getting events in the McLean News, contact Christine Tuohey, x2275
• To put your announcement on the video displays in the deMarneffe lobby and cafeteria, contact Laurie Sibilia (x3259).

 Center-Wide Events/ Holiday Functions

• The food/reservation expenses have been charged to Diego’s Sundry card. Because it is usually a center-wide event, these charges are then transferred by Janice over to the Pierce Sundry which doesn’t have a credit card. You should confirm with Diego whether this will be the case going forward.
• Before the event, you may need to get in touch with the Corporate Cards department, who are responsible for monitoring the corporate cards (mmcorporatecard@partners.org) to make sure that the facilities are approved.
• You will also need to fill out an advance authorization form from research administration regarding the specific number of people who will be attending, total cost, per person cost, and the date and venue of the event. You will also need a list of names of all attendees. The contact for this is Raquel Espinosa (x2868, respinosa@partners.org), but Janice will be able to provide up to date information about who the contact is for this.

Our experience with holiday parties:

• In 2012, the CDASR holiday party was held at the Asgard in Central Square. I’ve heard the food was good, but the space was a little cramped and it was hot.
• In 2013, it was held at Moksa in Central Square. It blizzarded that night so was underattended. There was plenty of room, but it was a little weird because it was basically a dance club. The food was so-so.
• In 2014, it was at Diego’s house and we ordered food from Sofra, which people liked very much. We also had a CDASR party at Diego’s house in summer 2014 and ordered catering from Basta Pasta in Cambridge, which was good.
• In 2015, it was at Flatbread Company in Somerville, which offers pizza and bowling. The food was very good, and they are able to accommodate nicely for food allergies. However, it was a little less festive than in years past.

Facilities Work Orders

You will submit work orders online for many different things:new keys, emptying recycling and CINTAS bins, emptying biohazard bin, urgent cleaning issues, temperature issues, new shelves, small construction projects, etc.  To create a Work Order or check status:

• http://bit.ly/mcl-workorder (aka http://phsmclgpm2/GpmWoRequest.aspx)
• Note that this can take a long time to get a response. Therefore, if it is urgent, you can call x2623

Laundry

To get clean towels and have the dirty ones picked up, follow the instructions in the orange EEG resources binder located in the EEG control room.

• Call x2620 or Roges at x2619 and leave message with location (DEM 235).
• Put the hamper outside of the EEG control room so that it can be picked up.
• Fresh towels get stored in the cabinet in the EEG control room.
• Make sure to record the date you called and your initials in the EEG resources binder.
• If having issues, contact Michele Holbrook at: Holbrook@dtz.com

Housekeeping

• Contact building services x2656
• Also, contact Roges Gedeon at x2619 for any persistent/urgent issues

One of the RAs will be responsible for booking Diego’s travel to conferences and meetings. Partners has an established relationship with Egencia (a Expedia corporation) that you should use to book all flights, and hotels that don’t have special conference rates

Travel Central (http://supplychain.partners.org/resources/travel-central.aspx) is the hub for all travel policies and procedures.

Egencia

Egencia is the corporate version of Expedia. Partners is able to get favorable rates for all travel booked through Egencia.

• Egencia website: https://www.egencia.com
• Remember to use the grant number to pay for the travel.
• Search flights on Egencia based on the dates/times Diego indicated.
• Find the best few around these times, screenshot the flight info, and email to him so he can choose which flights he wants. DO NOT BOOK UNTIL HE HAS CONFIRMED HIS PREFERENCE.
• After booking, Egencia will email you with the booking. Make sure to forward the flight information to Diego.
• Place the flight times into his work calendar. When making the event, copy and paste in the flight itinerary into the event message
• Add purchased flights to lab Expense Log: common/confidential/Expense_tracking/Expenses

Diego’s Flight preferences:

• Aisle seat
• Forward of wing
• Nonstop, if possible
• Jetblue or American Airlines if possible (ask Diego for his frequent flyer numbers)

Hotels

• When booking for a conference, check on the conference website to see which hotel the conference is being hosted at. Call the hotel to check for rates. You may have to book directly through the conference website.
• Email reservation confirmation to Diego.
• File the hotel booking electronically with the flight booking.

CDASR Website

We designed a new website for the CDASR in spring of 2012. Dave manages the website. Additional information about the website is located at the back of the training manual or at: Common/Admin/Website/UserGuide

• You should do a back-up of the website every month or so
• Diego will email you with announcements to go in the “News” section
• New members of the lab will also be added here
• Make sure that someone adds the speaker series schedule when it is planned and also if any changes occur

Recruitment Website

We maintain an external web page with simple study descriptions.  It provides a landing page for potential participants.

• The page/domain are http://www.mcleanstudies.org/.
• The site is hosted at wix.com, with an annual renewal fee of about $125.The account name and password are in the passwords file.
• When it’s technically feasible, this page should be merged into the CDASR web site and the Wix site should be retired.

Survey Website

We have a domain name http://mcleanstudy.org/ which links directly to our REDCap recruiting survey.  The domain name is registered at godaddy.com, and needs to be renewed annually.

Picking up Mail

• The CDASR Mailstop is 331. CAMDL & MLM gets mail delivered here in addition to the members of the LATN
• The RAs pick up the mail on a daily basis; you will have a day assigned to you
• Also, you will be responsible for bringing down outgoing mail. The outgoing mail box is on the file cabinet outside of the cubicles.
• Remember that if you are mailing unstamped mail out of the hospital, you will need to write the fund number of the grant you are using on the envelope.
• You can also Fedex mail from the mailroom. They have forms to use at the counter
• You can also pick up McLean envelopes and McLean letterhead for free at the mailroom, but not blank envelopes

Diego’s Calendar

One RA is usually in charge of managing Diego’s calendar, however all RAs are able to see and make appointments for him.

• To review general procedures, see: common\Admin\Pizzagalli\Diego_Schedule_Protocol (also see this folder for Diego’s electronic signature, CV, biosketch)
• This information is also at the back of the RA Training Manual
• Default meeting time is 45 mins
• You can email people the link to Diego’s calendar (cdasr.mclean.harvard.edu/index.php/dap-calendar) and then confirm once they choose a time. They can only see “busy” times and not the names of events.

Time Sheets

Monthly time sheets are administered by (Renee Braithwaite is gone, a replacement has not been named yet).  She sends out a blank form at the beginning of each month, which you fill in and return.

Partners Phone Directory (PPD)

This is the website where you can look up all Partners employees, their phone numbers, and their emails. Remember that the spelling of the name is important, and that you must have either full name.

• Located at: http://ppd.partners.org
• You can also use the paging service here for paging a study doctor.  (The simpler way to page someone is to dial “0” and ask for them to be paged.)
• Update you own location, extension, and job title here. This flows into the Exchange global address list.

Fund Numbers

Fund numbers are used in all billing, purchasing, payments, reimbursements and other financial transactions. Diego has two general funds (one for the lab and one for CDASR) and a handful of project funds. The project-specific funds can only be used for expenses that were explicitly in that project’s budget.

A complete and up-to-date list can be found in the Expenses spreadsheet.These are Diego’s primary fund numbers:

• LATN sundry aka Diego’s sundry: 400514
  • Used for expenses not directly related to a project
  • Used for most office-supply type purchases
• Pierce fund: 400619
  • For CDASR-wide expenses, such as EEG maintenance and supplies
• Placebo R01: 401150
• ELS R01 fund: 401181
• RDoC R01 fund: 401182
• UH Grant: 401185
• REWARD-31 fund: 401206

Other fund numbers exist for grants and awards for junior faculty and postdocs, which can be found in the Expenses file.

Tax-Exempt Status

McLean Hospital is exempt from sales taxes on anything we purchase. This exemption is taken care of automatically for purchases using a standard method such as eBuy or PeopleSoft.  For other purchases, including credit card spending, it is important to make sure the vendor does not add a sales tax.

• The tax-exempt number is 042-697-981
• A copy of the Tax exempt form (ST-5) is located on the server at common\confidential\Expense_tracking
• If you are making an in-store purchase, bring the form to wherever you are buying the item and hand it to the cashier. This is especially worth remembering if you use your own money to purchase something, because McLean will not reimburse you for the sales tax.
• Some online vendors will ask you to contact them by phone to place an order.
• Some online vendors (PhD Posters, for example) allow you to enter the number into the comments section when ordering.

There are many types of expenses including:

• Purchasing something, on eBuy
• Submitting an expense report (the Expenses module in PeopleSoft)
• Using a credit card
• Paying an invoice (a Special Item in eBuy)
• Booking travel (on Egencia)
• Sending a compensation check to a subject (eCheck)
• Incurring an expense from any internal department such as catering or the pharmacy
• Calling a taxi for a subject
• Obtaining and disbursing petty cash

If you spend any departmental money, you are responsible for keeping track of that expense and making sure that the correct amount and fund gets charged.   It is especially important to use the right fund number or right credit card in every transaction.  If you aren’t sure which fund to use, ask Diego.  If you ever use the wrong number—including times when you do it on purpose—tell Janice right away so the charge can be transferred quickly and correctly.

The Expense log files

When you spend money, you must record it in the Expenses spreadsheet, at common\confidential\expense_tracking\Expenses.xlsm, or in one of the specific log files for subject payments, petty cash, or taxi payments.

Receipts

You also need to keep a copy of the receipts. Each RA needs to file the receipts for each expense in his/her filing cabinet. Here are some tips

• Keep all receipts. If receipts are small, tape them to a piece of printer paper or scan as pdf and print a copy
• Keep the funds separate, and within each fund file the purchases by month.
• If multiple confirmations/receipts come for the same purchase, staple them together to avoid double counting
• Clearly distinguish between credit card expenses, purchases made through eBuy, and internal spending charged directly to the fund (e.g. pharmacy or catering charges)

Keep track of every subject payment in your study’s Subject_Payments log file.  These payments don’t need to be entered in the Expenses file, however you will need to reconcile them with the monthly spending report. Subject payments are PHI and any hardcopy records must be filed in a LOCKED cabinet the with other PHI.

Expense Reports

An expense report must be submitted for all travel costs, or whenever an employee is reimbursed for a personal expense. A receipt for every expense has to be included. The Expenses system is in PeopleSoft Finance, under the menu for “Employee Self-Service > Travel and Expense Center”.  All the related policies and procedures are on the Supply Chain intranet at http://supplychain.partners.org/resources/travel-central.aspx.

Each month, Janice will circulate a report listing all the expense charges that have hit Diego’s funds in the past month. Each RA reviews it to make sure all of their spending is listed correctly.  Here are the things to check for:

1. Are there any expenses that we don’t recognize? When you are the primary RA for a project, review every charge against that project to make sure they make sense because some other group might have charged our funds by mistake.
2. Did any expenses get charged to the wrong project within our lab? We might have charged something incorrectly.
3. Are there any expenses that didn’t show up when you expected them? Maybe it was charged to another lab by mistake and we need to find out quickly. Or, maybe the finance group didn’t send the check yet and the vendor will call us to complain.
4. Are the amounts correct?

It’s very important that any corrections or transfers are completed by the end of the month, so let Janice know if you see any.

Transferring between Funds

Janice is able to transfer a charge between funds within a certain time frame, so it’s critical to let her know as soon as possible when you notice a mistake. It’s extremely difficult to make a correction to a Federally funded grant such as an R01 or K23 if it’s not done right away.

Sometimes you will use a different fund on purpose. For example, not every project has its own credit card, so a Craig’s List ad for those studies would use the Sundry card.  A second example would be when you want to split the cost between two projects (e.g. 50% to RDoC and 50% to ELS).  A third example is for a new project that doesn’t have a fund number yet.

In these cases, let Janice know in advance that the charge will need to be transferred.   Always use a sundry fund as the temporary source, because it is much harder to transfer an expense if it was made to an NIH grant. because these changes are audited by the NIH and extra documentation may be needed.

Diego has corporate credit cards for each of his major studies: REWARD-31, GABA, UH, ELS, and RDoC (the ELS and RDoC cards will end in May 2017).  In addition there are two general purpose cards, one for LATN and one for the Center.

• Dave manages the credit cards for the lab.
• Specific information about each card can be found in the common\confidential folders
• You should file a hardcopy record of credit card purchases in the locked file cabinet in your cubicle. Place the receipt in the appropriate month for the appropriate card.
• Make sure to log all credit card spending in the Expenses.xlsm file
• If a card gets declined it is usually for one of two reasons:
  • The mailing address for the card was entered incorrectly.  Consult the Diego_Cards file, and use the address exactly as it appears
  • The vendor isn’t in an ‘approved’ category. This can happen unexpectedly with a new vendor, or even with a new taxi service while travelling.  The Corporate Card group can enable the vendor, or the entire category, for future use. You can email mmcorporatecard@partners.org or call to get approval. Usually they are pretty reasonable, but it will take a day or two to make the change.

Some studies or projects do not have their own corporate credit card, so they will use the LATN Sundry card instead (for example, to pay for a Craig’s List ad).  Whenever you use the Sundry card for a project, the expense will subsequently have to be transferred to the correct fund.  Enter a note in the Expenses file identifying the study and send an email to Janice including the date, vendor, amount, purpose and any other relevant information.  This will let her know that the charge needs to be moved from the Sundry fund to the correct project fund.

Ordering Supplies or Services through a Website

If something is not available through the eBuy portal, or if the vendor is not an approved Partners vendor, one option is to order the item online using one of Diego’s credit cards.

• Note that many items not available from a preferred vendor on the eBuy portal can be ordered using a Special Item Request on eBuy.
• Ordering through a website is usually done for psychological society memberships, conference hotel bookings when there is a conference rate that Egencia doesn’t have. Some software products and other digital products can only be purchased this way. Buying from Amazon.com can only be done with a credit card.
• The Corporate Card Management department reviews all credit card spending. If you know the purchase will attract attention (i.e it’s a large expense, or not obviously related to research), it is sometimes worth emailing to alert them that you will be ordering online. Similarly, if you run into problems, you would contact them to get permissions to order the item. Email mmcorporatecard@partners.org
• Remember to print the receipt and file under the appropriate grant card folder.

The purchasing and finance systems that we use most often are managed by Supply Chain Management (SCM, formerly known as Materials Management). SCM is a Partners organization that covers many central corporate functions including supplies, purchasing, contracts, and vendor management. Most importantly for us, they are responsible for the important financial systems we use: eBuy for purchasing, eCheck system for subject compensation, and Expenses for submitting expense reports.

SCM website: supplychain.partners.org (note: only accessible inside partners network)

SCM Client Services Helpdesk

Client Services help desk: 617-726-2142

The Client Services Helpdesk is without doubt the most helpful helpdesk at Partners, so call them whenever you have a problem.  Some of the situations Client Services can help you with are:

• If your subject complains that they haven’t received their check. Client Services can find out when the check was sent, what address it was sent to, and whether it was cashed. If the check hasn’t been cashed for over 45 days, they will stop payment and issue a new check.
• If a vendor says they haven’t been paid yet, call Client Services.
• If you need help submitting an expense report, or getting a reimbursement, call Client Services.

Training and Access for eBuy, eCheck, and Expenses

This table and the links were copied from the SCM website at http://supplychain.partners.org/training-and-application-support/getting-access-to-peoplesoft.aspx

To be rewritten

eBuy is the primary system for making purchases.

• To use eBuy, go to PeopleSoft then navigate to Financial Production > Main menu > eProcurement > Create Requisition (bookmark it!)
• Follow the instructions at eBuy’s web-based training
• Once a requisition has been submitted, you should file it in your cabinet under the appropriate grant that was used to purchase the item.

Common purchases

A list of commonly purchased items is maintained in the Expenses spreadsheet.

• Urine Pregnancy Tests: ordered through Fisher Scientific on the eBuy portal
  • Item: QuPID Pregnancy Test (50/pack)
  • Manufacturer: Stanbio Laboratory, Inc.
  • Vendor: Fisher Scientific Vendor ID: 0000001045
  • Vendor Item ID: SB-1220025
  • Manufacturer Item ID: SB-1220025
  • Units per box: 50
  • Price: varies
  • The item type is LABSP (Lab Supplies)
• Urine Drug Tests: use the Special Item order tab with the following information
  • Vendor ID: 0000364851
  • Item: AmediCheck Clia Waived 12 Panel Cup
  • Vendor Item Id: ABI-CW12
  • Unit of Measurement (UOM): PK
  • Price: $175.00
  • The item type is LABSP (Lab Supplies)
• Toner/Ink: Order through the Staples web function
  • For color printer: HP Inkjet Cartridge, 940XL, High Yield: Magenta (staples item # 772998) Cyan (staples item # 772994), Yellow (staples item # 772997), Black (staples item # 772995) and HP Printhead 940: Cyan/Magenta (Staples Item # 773876) and Black/Yellow (Staples item # 773874)
  • Recycle old toner, ink cartridges, and batteries at the mail room!
  • The item type for all Office Supplies is OFSUP.

The most common use for eCheck is to send payments to subjects for study visits.

• eCheck training information: http://pulse.partners.org/services/training_echeck.htm

Subject payments

To submit a request for a subject payment, refer to the information that the subject provided at the study session.  You will need their full name, mailing address, and their social security number. You also need the fund number of the study.

• Login to PeopleSoft
• Navigate to: Financial Production/Accounts Payable/Vouchers/Add/Update/Regular Entry (bookmark it!)
• On the first form, fill in the “gross invoice amount” with the amount the subject will be paid. Click “Add”, and this advances to the second form.
• Fill in the subject’s information under the “single payment vendor” tab. If the subject does not have a SSN, enter “foreign” in this field.
• Click on “invoice information”.  Fill in the Dept. Number with six zeroes: 000000. Then fill in the “Account” as 990000, and the “Fund” as the grant number you are paying the subject with
• Click Save, then “printable view” and print the receipt
• Store the receipt in file cabinet
• Update the Subject Payment Log (under common/confidential/)

Issues

• If a subject has a problem with a check (typically they’d say in never arrived in the mail) contact Client Services at 617-726-2142.  They can tell you whether the check was mailed, and when, and to what address. And they can tell you whether it was already cashed (and even send you an image if the check, if you need to prove to the subject).
• If the check is truly lost, Client Services can stop payment and issue a new check.  But they won’t do this until 45 days after the check was sent.
• Cathy O’Connell is the manage of Research Finance at McLean, and she is in charge of eCheck training. She is also a great resource for any questions about reimbursements, check requests, expenses or petty cash.

The application you use to file expense reports is called Expenses.  All travel-related spending must be reported via e-Expenses, even if it was paid for using a corporate card or Egencia. This application is also used to obtain a reimbursement when someone spends their own money for something such as parking at the Martinos Center or printing a poster.

• Training: http://pulse.partners.org/services/training_expenses.htm
• Diego will name an RA as his delegate within the system so they can submit expenses for him
  • Diego should log into his PeopleSoft, navigate to financials production->employee self-service->travel and expense center-> Delegate
  • Then he should add you as a delegate by entering in your Partner’s ID

To submit an expense report:

Update is required: some of these instructions are obsolete, because of the new eWallet application. Refer to the training material on the Supply Chain website for the latest procedures.

• First, tape each receipt to plain paper. You can have multiple receipts on a page, but make sure they are all readable. It is good practice to write next to each receipt what it is for, and whether it was paid with the corporate card, personal card, or cash. Labeling isn’t necessary, but it makes things easier for AP, and also for you if you have to look back at old expenses.
• Login to PeopleSoft
• Navigate to Financial Production/Employee Self-Service/ Travel and Expense Center/ Create an Expense Report
• You will need to click the magnifying glass to indicate who you are creating this for (i.e you or Diego)
• Select “blank report”
• The approver is usually Janice, but for the MIC speaker series reimbursements, it is David Olson. Make sure to select the appropriate person. This is done on the top-right of the form.
• Write a description of the event
• Fill out the Expense type, date, amount, payment type, etc (usually local expenses).
• Business purpose is usually general expense
• Fill out location (Boston)
• Click on “*Detail” and provide a more in depth description of the expense. Diego likes to list who he went to dinner with and why for example.
• From “Detail”, select “Accounting Detail” and fill out the appropriate billing information, putting the cost center as the “Project” and “1600” for the GL Unit, and if necessary put “000000” under “Dept”
• Click check expense for errors. If they come up, write a reason in the appropriate box (if the dinner is coming up as too expensive, but it was for 2 people, indicate “dinner was for two people” in the Amount Exceeded row)
• Click submit
• Now upload the pdfs if you have them, or it is okay to fax the receipts with the coverpage of the expense report
• Print the expense report in NON-printable view. This will give you an itemized printout of the expense report which will make it much easier if you have to reference the report in the future.
• Click, printable view and print a copy, make sure the barcode prints properly
• If you are submitting an expense report for a trip Diego took, you keep all of the receipts for the trip in one expense report. You will also have to track down the hotel reservation and the flight booking to include in the faxed documents (even though these are booked through Egencia using a fund number and therefore don’t need to be officially added to the expense report). I usually write on the bottom of the reservations not included in the report, “Booked through Egencia using a Fund number, no reimbursement needed”. Finally, you will need to include a print out of the conference schedule, which can usually be found online. This is also included in the fax.
• File the expense report in the appropriate folder for the grant that was used to pay for the travel under the month that the expense report was submitted

For some of Diego’s behavioral experiments, it is more effective if subjects can receive immediate cash for their performance as opposed to waiting weeks to get a check in the mail. Petty cash can only be used for payments under $50 and only for one payment per subject.

Each study keeps its own petty cash in the cash safe. Cathy O’Connell (x2637) can answer any questions you have about the petty cash process

Requesting a Petty Cash set-up

• Pre-Approval from the IRB Office
• Memo from the PI to research director (email both Cathy and Raquel Espinosa) requesting a petty cash set-up that should include the following information:
  • PI Name
  • Study title
  • Protocol #
  • Project period
  • Person responsible for the cash and contact information (address, email & phone number)
  • Petty cash amount
  • Amount to be paid total per subject
  • Amount to be paid per subject visit
• Once the letter is returned, you can fill out a check request for the petty cash

Check Request

• We have usually requested a larger check with enough money to last six months
• Use the Expenses system to fill out the check request, as you would a subject payment
  • Under Single Payment Vendor: Name: “Petty Cash”
  • Under address: put the cash custodian’s (your) name here, then fill out McLean’s address
  • Under Invoice Information: Account 919700, Project: your fund number
  • Under comments put “Handling code ML”, and the contact name and phone number of the cash custodian.
  • Also include how the petty cash will be broken up ex:“$300 to pay 30 subjects $10 each”
  • Attach a scanned copy of the approval letter, and submit.

Cash Handling

• The check will come to Cathy O’Connell about 2 weeks after the request was made. She will call you when it is ready for pickup, but if you don’t hear from her it is worth calling to ask if it is available.
• Once a check is received by the person responsible, it can be cashed at a bank. (?? at petty cash office??)
• The cash should be stored in the petty cash safe. Each study should be keep its cash separated in an envelope or pouch of its own.

• The subject must sign a receipt when they receive cash. You should find preprinted receipt forms in the safe.

Payments and Records

• The receipts should stay in records for a period of 3 years after the close out of the study.
• Update the Subject Payment spreadsheet with the subject’s name, social security number, date, amount dispersed, and the name of the RA who dispensed the money to the subject
• When requesting more money, you must attach a copy of the subject payment record so far, complete with an indication of when the previous petty cash check was received, and the number of subjects who receive money from the previous check.

We occasionally have to process invoices, typically for services such as cortisol analyses. Note the standard Partners policy is to issue the check 45 days after the invoice is received.  If an invoice needs to be paid more quickly, be sure that everyone involved with this invoice is aware of the time required. To check on the progress of an invoice, call SCM Client Services (617-726-2142).

This must be rewritten

First, establish a purchase order for the invoice in eBuy:

• Define Requistion

• Buyer, category etc: can leave this blank as will define these in 2. Add items & services
• Accounting details: enter dept (should be 000000) and project (the fund #). If want to split payment up by several funds, hit “+” sign on left to add more rows and then enter “pct” (needs to add to 100)

• Add Items and Services
  • The type of purchase will almost certainly be a ‘special request’
  • When paying for a service such as a scan or cortisol analysis, select ‘fixed cost service’. Otherwise, use your best judgment or contact Materials Management
  • Fill out the various blanks as accurately as you can, using direct language from the invoice (e.g. service description, value of service). Category for services often will be “outside service – other”. Look up vendor name and ID. Leave start/end and quote info blank.
  • In the additional information box, add the send to/remit to information included on the invoice. Example:
• Please issue a check for the total amount cited above and payable to BRANDEIS UNIVERSITY. The check should be mailed to:
• Philip T. Gnatowski
• Department Administrator in Psychology
• Brandeis University
• 415 South Street (MS-062)
• Waltham, MA 02454-9110
  • If you don’t follow this step, the check will go to the wrong location!
  • Add the service or item to the purchase order
• Review and Submit:
  • add the same send to/remit to information from the invoice to the comments area. Indicate that the invoice is attached and should be consulted for further information.
  • attach the invoice in the comments area
• After a few days, you should receive an email from Purchasing that your purchase order has been processed. This email will include the purchase order (PO) number. If you do not receive this email within a few days and the invoice is urgent, contact Purchasing.
• Send the invoice and purchase order number to Accounts Payable
  • Print out the original invoice
  • Add a sticky note to the invoice with the purchase order number. Also include your contact information
  • Send the invoice to Accounts Payable via interoffice mail

Poland Springs Water

We have Poland Springs water available for mixing the electrolyte solution for EEG sessions (1 gallon distilled water), and small water bottles (500ml) for participants and speaker series.

• The small bottles are stored in the file cabinets outside of the cubicles (#3), and the larger gallon containers are stored in the EEG room.
• Water is ordered by sending an email to Scott DeFeo (Defeo@waters.nestle.com)
• Our account number is: 0438687238
• Use Center-wide (Pierce) fund
• The products to order are: cases of distilled water (6 gallons per case), and 24-packs of ½ liter bottles
• Make sure to ask for an invoice.

Here is a sample email:

Hi Scott,
I’d like to order more water for our lab at McLean Hospital. We would like:
    2 cases (48 bottles) of 500ml Poland Spring water bottles and
    12 Gallons (2 cases) of distilled water.
The address is:
   McLean Hospital, Mailstop 331
   115 Mill Street
   Belmont, MA 02478
Our account number is 0438687238 and the grant fund number we would like to use is: 400619.  If you could please send me the invoice or total amount, that would be great, thanks.

Ordering Books via Rittenhouse

• Amazon does not accept purchase orders, so orders for books need to be made through Rittenhouse: call +1 (800) 345-6425 and use acct # 012959 – we get a 17% discount with them. For questions contact Josephine Amico.

Independent Consultants and Contractors

Out-of-date

This is a way of paying for outside services that are not Partners entities, and we don’t want to set up as a Partners vender. Note that this process is a HUGE pain, and can take months to complete. Avoid it if at all possible.

• Joanne Miller is the contracts specialist for Partners, her email is JMILLER17@PARTNERS.ORG, and she can help guide you through the process.
• Info is on: http://pulse.partners.org/mm/indcontractor.htm
• Read over the 5 questions on the ‘Independent Contract Form’ found at common\Admin\Contracts
• If the answer to any of the questions is ‘yes’, there is a high likelihood that Partners will reject the independent contract request

To be supplied

Privacy and Confidentiality

To be supplied

Most of this section needs more information

We use a number of sources for recruitment in the lab. The most successful are the BU quickie jobs board, and Craigslist.

Online Recruitment Survey

Additional information to be supplied

There is a general recruitment database for LATN studies called “Lablab”. It is password-protected on the Jupiter common server. See instructions in the first tab of Lablab for use.

In order to contact participants from this database, you MUST be on study staff for the studies referenced.

Internet Advertising

Craigslist

Free Option ($0/ad):

• http://boston.craigslist.org/vol/
• At the top right corner of the “Volunteers” page, there is a link called “Post”
• When asked to choose a category, choose “Volunteers”
• When asked to choose a region, choose whichever best fits (e.g. metro west or Boston/Cambridge/Brookline)
• Put the IRB-APPROVED text into the “Posting Description” section (you may need to shorten your title to fit)
• Under “Compensation,” put the full amount of compensation subjects may earn
• Easiest way to post the ad, is to re-post!

Paid Option ($45/ad):

• http://boston.craigslist.org/etc/
• At the top right corner of the main page, under the “Jobs” column, scroll down and select “[ETC]”
• At the top right corner of the “Jobs” > “et cetera jobs” page, there is a link called “Post”
• When asked to choose a category, choose “et cetera”
• When asked to choose a region, choose whichever best fits (e.g. metro west or Boston/Cambridge/Brookline)
• Put the IRB-APPROVED text into the “Posting Description” section (you may need to shorten your title to fit)
• Under “Compensation,” put the full amount of compensation subjects may earn
• Easiest way to post the ad, is to re-post!

Other websites

• Clinical Trials at Partners (http://clinicaltrials.partners.org/Main.aspx)
  • Note: this is a Partners web site is not the same thing as ClinicalTrials.gov. See below for more information
• CenterWatch (http://www.centerwatch.com/)

College recruitment

• See document saved under common/participants/flyers
• BU quickie jobs is very easy and very high-yield!!

Clinicaltrials.gov

Any protocol that has an ‘intervention’ (MRIs count) must be registered on clinicaltrials.gov. This is a government website run by the FDA. You must provide yearly updates on the trial posting.

• https://register.clinicaltrials.gov/prs/app/template/MainMenu.vm?ts=1&cx=-9fe60x
• Password is in common/confidential/passwords

Paid Advertisements

Postcards

Both CAMDL and LATN have worked with Northpoint Printing to send out postcards to specific demographics within a definable radius of McLean. A postcard drop of 2500 costs about $1800. Here are the steps involved in creating and sending out postcards:

• Use Adobe Illustrator to create a postcard. You can find a past template here: Z:\common\Participants\Postcards for recruitment
  • Adobe Illustrator is installed on the Workstation-10 computer.
• Submit the postcard (in PDF or .doc format) to your study’s IRB. Make sure that your study protocol mentions use of postcards in the section on recruitment. If it does not, you may need to amend the protocol as well as submitting an image of the postcard.
  • Once the IRB approves your postcard, you can email a PDF version to Mike Sullivan at Northpoint Printing: ms@northpointprinting.com. Be sure to include:# of postcards you would like to drop
  • Geography > Radius > Address Based Radius (we have specified 10 miles in the past)
  • Demographics > Gender
  • Housing Type: (we have specified single family & multi family, not PO BOX)
  • Ask for a price quote.
• Once you approve the price quote with your PI and Mike sends out the postcards, you will need to use Peoplesoft to create a requisition. On the “Add Items and Services” page, you should click on “Special Request.”
• 1-2 days after submitting the payment to Northpoint Printing, you should receive an email from Josephine Amico that includes a PO# for the invoice. You must email this PO# to Mike Sullivan to complete the transaction.

Advertise on the T

• Expensive, and not exceptionally high yield
• http://www.mbta.com/business_center/advertising/

TrialSpark

To be supplied

Flyers

IRB-approved flyers are in common/admin/flyers.  In general, it’s a good idea to keep a list of places you flyer and every 2 weeks or so go check them out. You may need to post new copies up because the tabs are all gone. You also want to be sure to take them down before they reach the IRB expiration date. We have a google doc and google map of flyering locations in the area.

On the McLean campus, basically you can flyer anywhere there is space on one of the cork boards. Make sure to use IRB-approved fliers, they should have an IRB stamp on them. The hot spots are:

• Both doors of the cafeteria
• By Cole Resource Center (to the left when walking with your lunch to find a seat inside),
• In Admissions across from the elevator,
• In North Belknap next to the elevator,
• Across from the vending machines by the mail room in the tunnels
• Any place else you can find a cork board or other research flyers! If you want to post them in particular departments (say the Geriatric Psychiatry unit) you should ask the director or secretary of the department if it’s okay to do so. Most departments have locked cabinets where they hang flyers and have limited space for their own advertising.

If you want to flyer in the community, say at a coffee shop, grocery store, gym or library, it’s best to ask someone that works there if it’s okay to put up the flyer.  Harvard removes flyers around 8am on Monday and Thursday.

To Be Supplied

Add a complete section on Lablab and the recruitment survey.  This could be a separate KnowledgeBase of its own.

To be supplied

This page is for training only.  For further instruction, please see common\participants\Phone_screening_materials\Suicide assessment and prevention materials

Occasionally, you will phone screen a participant who endorses suicidal thoughts. When this happens, you will need to go through the lab suicidality procedure. This is available in common\participants\Phone_screening_materials\Suicide assessment and prevention materials; but make sure to have a copy at hand as it has the appropriate questions to ask as well as the relevant steps to take

When asking about suicidal ideation, try to make the distinction as to whether the subject could be considered to be at imminent risk for self-injury/suicide.

If the subject has: suicidal ideation, but no specific plans or intent to take action on a plan (some people have thoughts or taking their life/self-harm or even a plan, but say they could/would never do it); resources he/she can rely on and has relied on in the past (family, friends, therapist, counseling, etc); plans for the week/next week—then he could be considered to not be at imminent risk

On the other hand, the following are risk factors for imminent risk: suicidal ideation with a specific plan and (at least) some intent to take action on a plan, prior suicide attempts and instances of self-harm, few resources he/she can rely on, few plans for the week

If you determine that the subject is not at imminent risk, you can contract for safety and then proceed with finishing screen. Make sure to send the participant a copy of community resources.

If you feel that the subject could be at imminent risk for self-harm/suicide, ask him/her to contract for safety. In addition, keep the subject on the phone! Ask others in the lab to help out by calling Diego, Dr. Olson, Nancy, Rosi, Alexis, Dr. Vitaliano, Laurie, Christian. Calling 911 may be necessary

To be supplied

LATN standard criteria

To be supplied

Study-specific eligibility criteria

To be supplied

Assessing mood and mental health

To be supplied

Assessing drug use history

To be supplied

Regulatory Binders

This section needs to be changed to reflect LATN standards

Every active study needs to have a corresponding regulatory binder that holds all relevant study information. See previous study binders for example. See the Partners Human Research Quality Improvement (QI) Program website (http://www.partners.org/phsqi/vrb/files/index.htm) for details. This website has an explanation of everything that needs to go into a regulatory binder. Also see the QI tools website http://www.partners.org/phsqi/ToolsPage.htm for appropriate forms and worksheets (you can adapt to suit your study) that need to be completed and included in the regulatory binder for each study.

All regulatory binders should include:

1. Protocol
   • Original protocol and all amended versions with dates
   • Copy of protocol signature page for original protocol and all amended versions
   • Protocol Version/Amendment Tracking Log
2. CV’s
   • Signed and dated CV’s for all study staff
   • **HOWEVER, you may create a lab-specific CV and CITI Certification Binder for your group, in which all your staff CVs and CITIs are filed. You will need to create Note-To-Files regarding the location of the CVs and CITIs and file this under the appropriate tabs.
3. Licensure
   • Valid licenses for all licensed professional study staff
   • Human subject protection training document (CITI training)
   • Medical licenses for the study physicians
4. Logs
   • Pre-Screening Log: for studies that perform screening procedures
   • Enrollment Log
   • Staff Signature Log
   • Delegation of Responsibility Log
   • Monitoring Log
   • Drug Accountability Log: for studies that involve drug administration
   • Protocol Version/Amendment Tracking Log
   • Adverse Event Log
   • Protocol Deviation/Exception Tracking Log
   • Protocol Violation Log
   • Subject Contact Log
   • Temperature Log: for studies involving storing samples in a freezer
5. IRB
   • Copies of all signed and dated IRB submissions
   • File in reverse chronological order (most recent first)
6. Consent Forms
   • File all copies of originally stamped consent forms (should have red stamp)
7. Data Collection:
   • File blank copies of source documents, study visit checklists, etc
   • File any forms given to subject for completion

Insight

• Insight is the website to manage the IRB for all protocols online
• https://insight.partners.org/public/
• McLean has trainings for learning how to use insight
• Insight works best using internet explorer or Mozilla firefox. If you get errors while using Insight, it is best to try a different browser.
• To see all of the protocols which you are listed as study staff on, click on the “Humans” tab
• You can see the details of the IRB submissions by clicking on the protocol title
• On the pending applications tab, you can track submissions that have already been submitted. You can see where they are in the process of getting approved by clicking ‘workflow history’
• Submissions (initial submission, amendment, continuing review) you are working on, but have not yet submitted, can be found in the ‘Works in Progress’ Tab. Make sure to hit ‘Save’ often while working on a submission
• Actions you need to take, such as approvals, can be found in the ‘Activity List’. Insight should also send you an email when you need to approve something, but Insight is not reliable!
• When preparing an amendment or continuing review to go into insight, it is best to prepare documents on the server before and then just upload them into insight. Another helpful hint for amendments is to keep track of what changes you are making to the protocol and why and also where the IRB administrator can find the relevant pages (e.g. “We would like to increase the enrollment limit for the study, due to a higher-than-expected rate of participants enrolled who do not meet criteria. For the relevant changes please see page 8 of the detailed protocol”)

Amendments

• If you are making any changes to a protocol, you will need to submit an amendment
• There are two types of amendments, study staff and regular amendments
• For regular amendments, you will need to upload marked (track changes) and unmarked versions of all of the documents in the protocol that are being changed in the amendment. Note that in order for insight to recognize ‘marked’ documents, you will need to upload it as a pdf and NOT a word document. For unmarked copies, it is best to upload as a .doc/.docx. ‘Marked’ and ‘clean’ versions should be added on the same line, with the ‘marked’ version added first and the ‘clean’ version added second, such that the ‘clean’ version is the top, most-recent version.
• Print off the submission when you submit, and save it on the server.
• When the IRB receives the submission (after Diego or other PI signs off on it ) you will receive a notice through email
• Periodically check the workflow to check on progress and see if the amendment gets stuck awaiting a signature/approval
• When the IRB approves the amendment, you will receive the approval document through email. Save this on the server and in the IRB binder
• Sometimes amendments that have significant changes will go to full board review. The IRB board only meets once or twice a month, so when an amendment goes to full board review, it will take longer to get approved.

Study Staff Amendments

• Go to humans, and click on the protocol
• Click on create new process -> amendment
• Click save, then click the Staff and access tab
• Click ‘add new staff’
• Search for the staff member
• Allocate their role in the study
• To remove study staff, next to the staff’s name, click edit, then remove, then save
• Finally click submit, print the amendment, and save it on the server

Continuing Review

• Each year, a continuing review of the protocol must be done, even if the study is not yet recruiting or has completed recruitment
• You should receive an email notifying you 90 days before the protocol expires. However, try to keep in mind when the protocols you are responsible for expire. Again, Insight does not always reliable send out emails. It is important to submit the review within 45 days of the protocol expiry date so that the IRB has enough time to review it. You will receive a notification of the 45 day date through email
• For a continuing review, you will need to submit all protocol documents, the minor violation tracking log, the adverse event log, and an enrollment report
• You will need to review the study staff to make sure that there are no expired CITIs
• Diego likes to review all CRs before you submit them to the IRB

Ceding Review to Another IRB

• Some of our studies have procedures that take place at sites outside the scope of the Partners IRB (such as Harvard). In this case there are two options: 1) Each site has an IRB protocol (e.g. separate protocols and consents). 2) One site cedes review to the other site’s IRB and relies on their oversight (e.g. Harvard IRB cedes review to Partners IRB, so we only have a protocol and consent). Have one site cede review to the other will save a lot of hassle in the long run

• To learn more about the cede-review process: http://catalyst.harvard.edu/services/irbcede/

Update this section to include the “R”-style design.

All of our studies use an online data collection system called RedCap. So long as you have an internet connection, you can use RedCap to administer surveys to participants. By having participants fill out the questionnaire themselves, it reduces data entry errors.

To learn about how to use RedCap, watch the tutorials on: http://www.project-redcap.org/index.php

When setting up a survey, and then moving it to the production stage, this will have to be approved by a RedCap administrator. This can take a couple of days. Also, if you need to make changes to a survey once it is in production stage, you need to request this from the administrator as well. Keep this in mind when making changes to existing surveys

When making a survey, there are two ways to do this: the Excel ‘data dictionary’ way, and the manual ‘online designer’ way.

• Use the Excel data dictionary when you want to combine many already existing questionnaires into one survey (ex. BIS-11, BDI, TCI all in one survey). To do this, open the data dictionary for each of the already created questionnaires, copy and paste the questions into a new excel sheet, and then upload the compiled data dictionary. This is by far the fastest way to create a survey
• You can manually create a questionnaire as well, using the ‘online designer’ in REDCap. This is slow, but is usually done when making a new questionnaire.

Investigational New Drug (IND)

Out of date information:

For REW22 and the Trauma grant, we use a drug called Amisulpride which is not FDA approved in the US. Because of this, we have an IND from the FDA that allows us to use the drug. Both of these studies are covered under the same IND. Information on the IND is located at: common\Reg_Binders\Shared\Drug_and_Safety_documentation\IND_107564_Amisulpride

• There are two main forms that we have for the IND: the 1571 (application) and the 1572 (for study staff)
• For any amendment and annual report, you will need to submit the 1571. Track the number of the application through the serial number section on the IND.
• At the anniversary of the IND approval, you need to submit an annual review of the study protocol. This will include a progress report, and a cover letter, and also the drug information
• During the annual review, you can also submit any changes to the protocol, and changes in study staff
• You mail hard copies of the review to the FDA. You will not hear back about the review unless something is wrong with it.
• To find the questions you need to answer on the annual review, copy and paste from the previous year review

Pharmacy

Find additional information at common\admin\pharmacy. The process for amisulpride order/supply is subject to change. Be sure to always check with Laura Godfrey.

Setting up a study with the Pharmacy

• When you are designing a study for the first time (in the protocol writing stage) you should contact the research pharmacy to discuss study design and manufacturing the drug. Laura Godfrey x2777 is who you want to be in touch with. She only works M-Th in the mornings.
• She will then start the process and will review the protocol, and then set up a meeting with you and the PI to discuss specifics on the randomization and the manufacturing.
• She will be able to provide you prices for services as well
• Laura will make an order form for the study which we will fill-out, have signed by the study doctor, and then bring to the pharmacy. Of note, Laura generally needs 1 week notice for dispensing (organizing pills and putting in blister packs) and 1 month notice to make a supply of pills.
• Laura needs a signed letter from Diego authorizing her to dispense the drug for and also noting who is authorized to pick up the study drug. RAs can be authorized for this.

Ordering new drug for a study

• Plan ahead! One month notice is required for the manufacturing of new pills and one week is required for dispensing new blister packs
• During the study, the randomized drug will expire and you will have to order new drug.
• You do this through the pharmacy order form, also email Laura to let her know you will be coming by. Remember, Laura is only in Monday-Thursday in the mornings.
• Note which subject number you would like the new drug to start on, and how many pills you would like.
• You will need to have the study doctor sign the form and then you will need to drop the form at the pharmacy

What happens if a participant takes a pill but does not complete the scan?

(e.g., subject discomfort/claustrophobia, adverse event, scanner malfunction)

• Alert Laura, she will move this participant’s randomization code to the bottom of the group’s list
• If the subject is re-scheduled, use the next pill/randomization for him/her

When you are scheduling a session, be sure to reserve everything you need right away to avoid schedule conflicts.

Google Calendars

You will need access to the Google calendars for the people (clinicians, doctors) and resources (laptops, testing rooms) that are required for a study session. One of the other RAs will be able to give you access to most of them, but you may need to contact some individuals to ask for access. Beyond these, you should request access to the calendars of RAs and investigators as-needed.

Clinician calendars: Lynn Alexander, Nancy’s Calendar, Laurie Scott, Mei Hall (ask her for access), Emily LATN Calendar (for Emily Belleau)

Laptop calendars: Dell laptop, Large Lenovo, Lenovo Ideapad, Lenovo Laptop – Small Screen, Macbook-1, Macbook-2

Testing Room calendars: 227 Testing Room, 228 Testing Room, Behavioral Testing Room 237, Control Room (reserves 235 & 236), Control Room 243a, Experiment Room 243.

Study Doctors at the MIC: Dr. Olson for Pizzagalli, Gordana Vitaliano

Observe the following guidelines when reserving time:

• Include the study, your name and extension
• If a subject cancels, go back and release the time of everyone’s calendar
• For Clinical SCIDs, book 2 hours.
• For HC SCIDs, book 1 hour.
• If the clinicians will administer additional measures, or the subject has a particularly complicated history, think about booking more time
• Be sure to leave clinicians at least 30 minutes free for lunch around the middle of the day.
• ALWAYS reserve laptops on their calendar. Do not take a laptop without reserving. Also, sign the laptop out on the sheet in the cupboard. Make sure the laptop is fully charged when you return it.
• When reserving EEG rooms, include some time for setup and clean-up
• It is your responsibility to leave an experiment room on time if another study is booked immediately after yours.

Booking Study Doctors

To be supplied

Booking Rooms at the MIC

Some information is out-of-date.

There are three interview rooms at the MIC.  They can only be reserved during a scanning visit. The MIC has set the following rules for using these rooms:

• To book rooms for sessions at the MIC, use Calcium:
  https://calcium.mclean.harvard.edu/cgi-bin/Calcium40.pl?login
• No more than 2 ½ hours may be reserved per subject per group per room. Multiple blocks may be reserved but for no more than 2 ½ hours at a time.
• No group may reserve the same testing room for multiple, consecutive blocks on a given day. If multiple blocks are required, groups should alternate testing rooms as possible.
• Both testing rooms (169 and 171) rooms MAY NOT be reserved by the same group at the same time for the same study.
• Individuals responsible for the time reserved should indicate name, extension and study name for each time spot reserved.
• Staff should NOT knock or open the door if unsure if the room is in use; timed testing is often invalidated when subjects are interrupted during the completion of a task.
• All of your equipment, paperwork, accessories etc must be removed from testing rooms at the conclusion of the allotted time frame. Leaving laptops and other equipment behind causes needless delays for other groups and poses violations of subject/patient privacy and confidentiality.
• If you have reserved a time block and find that you will not need it, PLEASE remember to remove it from the Calcium calendar.
• The sign on the outside wall should be changed to reflect current status; i.e. make sure it says “vacant’ when you leave the testing room.
• There are four interview rooms in calcium, we use these rooms for SCID interviews that take place at the MIC (any study that requires labwork or requires Dr. Vitaliano or Dr. Olson to consent).
• There are also exam rooms at each scanner that can be booked for labwork during MRI scan sessions:
  • 3T Trio exam room: if someone else has a scan booked when you want to use the exam room (e.g. you need to do a blood draw before your scan) you must email them to make sure they aren’t using the exam room. It has a table for ECG, but you may need to get the ECG from another exam room. The internet is the best in this room. Wi-fi signal is great
  • 3T Prisma exam room: To be supplied
  • 4T exam room: This room is used the least, but it is usually available. A blood draw could be done here, but not an ECG. There is a centrifuge here for spinning blood. The -20C freezer for saliva samples is here.
  • MIC exam room: This is the room next to the 3T. It is not equipped as an exam room, so you must bring all your own supplies.  It is very cramped and there is no internet. There is no centrifuge, so if you use this room you will have to book an additional room for spinning the blood.

Scheduling MRI Scans

Some information is out of date

Each time that you book a participant for a study, you will need to request a scan time for them. You can do this in the reserved time for your study, or in “open time” that’s listed on Calcium. If you do not have a subject booked for a reserved time slot 48 hours in advance, you will lose the reservation and the time will be released for anyone to book it. Therefore, it is important to try to book participants in your reserved time first, rather than try to book open time on the scanner

Requesting a 3T slot for a study session

• If you are requesting a time from your reserved time slot, it is important to request it more than 48 hours in advance so that it will not get released as open time
• If you are booking open time, you can request it at any point. However, MRI requests for open time are completed on a first come first serve basis
• You will need to print the MRI Request form (stored in the exp folders of each study) and fill out the study doctor, the PI, your name, the date and time of the scan, what scans will be done, and also the subject’s name, DOB, and gender. You must also answer the yes/no questions at the bottom. The address and contact information for the subject is unnecessary
• It is important to use the subject’s full name (not nicknames) and print very clearly
• The form gets faxed to 617-855-3757
• If you have questions call Lynn Hathaway (she does the MRI bookings) at x3385
• Lynn will call you when she books the scan to give you the MRN for the subject. Write this on the top of the MRI request, and store the request in the locked cabinet in the folder labeled “MRI requests”
• To release pre-scheduled time, email 3TSCHEDULE@mclean.harvard.edu
• If your study is canceled on the day of (e.g. no-show, late cancellation), you must:
  • email the MIC list-serve to let them know that the 3T/4T is now free from X time to X time (same even with new scheduling system), include the reason the for the release (e.g., subject no-show, issue with scanner, etc)
  • email 3TSCHEDULE@mclean.harvard.edu with the same above information
• We are not charged for no shows and last minute cancellations.  This was factored in the utilization percentage for each group as this happens for all groups.  Scott recommends that groups with subject populations that tend to have cancellations to book a back-up subject.  There is IRB-approved language for this that can be shared to others.

Reserving the 4T for a study session

To be supplied.

Requesting a Developmental Scan

Out of Date

• You must fill out a ‘blue sheet’. These are kept in the supply/copy room at the NIC.available online.
• Fill out the reason why you are requesting a scan, and how many you are requesting.
• Have Diego review this document
• Send it to Scott Lukas to sign off on
• Then it must be manually dropped off to Kathleen
• She will keep this on file.
• You may only request a development time slot on the scanner 24 hours in advance
• If you need to request additional development scans for the study, you can edit the blue sheet (it will need to be approved again) or just fill out a new one.

Scheduling PET Scans at MGH

There is an online calendar for viewing available PET scan times. An interview room for questionnaires and computer tasks can be booked through this website. You will need to book a room for the beginning of the session and the end for a computer task and questionnaires

To book a PET scan:

• Go to: http://petmanager.mgh.harvard.edu/
• Log in with your partners id and password
• Click on the calendar
• We can book PET scans for our studies at 11:15am and 2:15pm. Sometimes other times (e.g., 10:30, 12:30) are available if you ask. PET scans usually take 1hr 15 mins ish.
• Call the MGH registration line (866-211-6588) to get the subject’s MRN number (mention that you are calling on the subject’s behalf and that he/she is only participating in a research study). Information needed: Name, DOB, Phone, and Address
• Note MRN in “Subject_Info.xls” in common/restricted/
• When you have the subject’s MRN, you will need to email Steve Weise (weise@pet.mgh.harvard.edu) to reserve the PET scan time. You should email him the following information:
  • Name of Subject:
  • Date of PET Scan:
  • Time of PET Scan Start:
  • MRN:
  • Date of Birth:
  • Subject contact phone number:
  • WOCBP:
  • Consenting required: No
  • IRB Protocol Number:
  • Imaging Compound: (ex:11C-Altropane)
  • PeopleSoft Fund Number:

To book a testing room for the PET scan:

• We use Room 233 in the White building for testing
• Log into the PET calendar website
• Click on “Shared Events” and create a new event
• This will allow you to book White room 233.

There are a number of options for subject transportation.  While we want to avoid unnecessary expenses, sometimes it is worth spending the money to ensure a subject can get to their appointment.

Public Transportation

• 73 Waverley bus from Harvard Square to Waverley Square
• Commuter Rail from North Station on the “Fitchburg/South Acton” line to Waverley Square

McLean Shuttle

McLean runs a shuttle from Waverley Square continuously during commuting hours (e.g. 7:00 AM to 10:00 AM), and on-demand throughout the day.  You can arrange to have a subject picked up and brought to deMarneffe or to the MIC by calling security at x2121.  Be sure to allow for the fact that the shuttle is not always available immediately.  The schedule is online at http://www.mclean.harvard.edu/about/directions/shuttle.php

Taxis

Note: As of 2015, LATN has tried to minimize taxi usage by encouraging use of public transportation or offering compensation for other means of transport (up to $25 or study-specific amount). Taxis are very expensive, and we have had many problems with communication between drivers and participants in the past. However, a taxi can be used if necessary.

McLean has a relationship with Veteran’s Taxi to provide taxis to and from McLean Hospital (and MGH as needed) for participants. This should only be used if participants cannot come by public transportation or drive.

Review to make sure these are up to date:

Booking a taxi:

• Make a taxi voucher, see below
• Call 617-527-0300
• Tell them you are calling from McLean Hospital with account 6410
• Provide the information about the date, time and person (and their phone number) who is being picked up, and also the drop off location (include building if at McLean). Also provide your phone number so that they can call you with any issues. For sessions at the NIC, remember to provide your cell phone and not your extension
• Email participant to remind them of the cab pick up and the company of the cab. Let them know they will receive an automated call with the driver arrives.

Taxi Vouchers

• We have taxi vouchers that we can use to monitor the charges to our account
• Blank taxi vouchers can be picked up from the mailroom
• Only put the participant’s first name and last initial on the voucher
• When a subject is dropped off at the session, give the voucher to the driver, and they will fill out the amount **(note that there should not be a tip on there). The driver will then give you the pink copy back, which you will later give to Dave.
• When a subject is leaving (call ahead to ensure the cab will be there on time. For taxi’s around rush hour, it is a good idea to call the morning of the session if possible) give the subject the voucher and one of the pre-paid return envelopes (see below). Remind them to put the pink copy of the voucher in the envelope and mail it back
• If you experience a problem with the taxi, fill out the back of the pink form with your complaint and give it to Dave, who will fax it to Kevin Kent.

Pre-Paid Envelopes

We use pre-stamped envelopes for taxi vouchers

• To get more envelopes, you need to go to the mail room and request pre-paid envelopes. Make sure to give our grant number
• Then fill out and print mailing labels with our address and mailstop and stick them on the envelopes

MGH Parking Passes

Review to make sure these are up to date:

For studies at MGH, we have parking passes that cover 4 hours of parking in the MGH parking garage. These can be used for both you and the subject.

• Put the sticker on the parking ticket, and bring it to the cashier when you are leaving
• To request new parking passes:
  • Use the parking pass request form that is located on the server at common/Admin/Parking_passes
  • White out the date, and put the current date
  • Fax the request over
  • Go to the parking office (same as the security off, located on the second floor of the Wang building) approximately one week after the request was sent to pick up the passes, make sure to bring over the request form!
• Call Steve Weise with any questions (617-726-5299)

Informed Consent

To be supplied

Drug and Pregnancy Tests

• For all interview sessions, our participants must pass a drug test for inclusion into the study. We use Amedi-Check urine drug tests, and they are in the file cabinet in the cubicles. For REW22 and Trauma interview sessions, we also do a urine pregnancy test
• For all MRI sessions, the participants must pass a urine drug screen and a pregnancy test. Pregnancy tests are stored with the drug screens.
• For PET scans, participants must pass a urine drug test, and the serum pregnancy test (female participants must show up ~1.5 hours prior to the PET scan to give ample time for the analysis of the serum pregnancy test)
• If a subject tests positive on either test, ask them about the result, and if they deny possibility of the positive result, it is okay to re-do the test if they are willing.
• Each of our studies have a urine drug test at every session

Urine Protocol

• When having a participant do a urine drug screen, you will want to use an exam room with a biohazard bin. Ideally the room will have a two way door that connects to the bathroom. The 1.5T and 4T exam rooms have this.
• Give the test and the paper bag to the subject. Ask them to screw the top on tightly when they are finished and to either a) place the test in the shelf of the two-way door or b) place it on a paper towel on the shelf near the mirror
• Be sure to wear gloves
• Peel back the label on the drug test to analyze. If you are doing a pregnancy test at the same time, use the urine from the test to drop into the pregnancy test.
• When you have confirmed the test is negative, you must pour the urine into the toilet and screw the cap back on.
• Then with one hand gloved (to hold the test) and the other ungloved (to open/ close doors) bring the tests back to the exam room and dispose of them in the biohazard bin.

Physiology: Blood Tests, ECGs, and Biopsies

Taking Blood Samples

To be supplied

Quest

• As noted earlier, we use Quest Diagnostics for our bloodwork
• During the study session, be sure to bring the Quest form and the quest baggie to the session.
• Once you have obtained your blood samples:
• Be sure to label each tube with the subject ID, DOB, and sex. Fill this out on the form as well.
• On the form indicate the tests you want run, check the box “bill to my account”, write “Dr. Olson” as the study doctor, and check “Fax results to: 617-855-4231”
• Call Quest for specimen pick-up
  • 617-547-8900 (provide study-specific or general screening account #) to schedule pick-up
    • write down confirmation number on your copy of the requisition
  • If you have expired tubes to dispose of, let them know that they will be picking them up as well and place them by the specimen pick-up box.
• The Quest specimen pick-up box is located on the ground to the right of the wooden desk in the foyer of the entrance of the MIC (clearly marked, keyed access).
  • Keys to the Quest specimen pick-up box are by the front door of the RA office 127b
  • Bob Baden will be able to order you a key to open this box.

ECG (“EKG”) Training

• You will need to be trained on administering ECGs
• In order to do an ECG on a female you must be female or have a doctor present
• Rooms that you can do the ECG in are the 1.5 and the 3T exam rooms (for the 3T, you must bring the ECG)
• The ECG will print out an analysis of the recording. It is often hyper sensitive, and therefore it will often report an abnormal ECG when it is in fact fine. You must bring all ECGs to the study doctor to approve.
• If an ECG prints out as abnormal, replace the electrodes, and try again. If it is still abnormal, try to find the study doctor to review while the subject is still at the NIC. Otherwise, save the ECG for review later. Don’t tell the subject that they have an abnormal ECG. Only the doctor can determine this. Say “I am only trained to administer the ECG, and not to read it. We need to have the study doctor review the ECG for study eligibility”
• Remember to write the subject ID on the ECG printout

Biopsies

To be supplied

Administering REDCap Suveys /Data Entry

Some information may be out of date

• Method 1: Open a public survey
  • Log in with your partners ID
  • Go to “My Projects” and select the survey
  • Click “Manage Survey Participants” on the left hand side
  • Click “Open public survey”
• Method 2: Open a survey for this participant
  • Log in with your partners ID
  • Go to “My Projects” and select the survey
  • Click “Add/Edit Record”
  • Enter a new or existing Participant ID (e.g., REW23-001)
  • Fill out the first section of the survey for the participant, this includes the Study ID (e.g., REW23, ELS), the Subject ID (e.g., 001);, the Session Number (e.g., 2); and the Date (select Today).
• Option 3: Send a link to the survey
  • click “Participant List” under the manage survey participants tab.
  • This will send an email to participants with a link so that they can fill it out at home
• When you are ready to download the data to analyze, go to “Data export Tool” and click “export data now”. You will most likely want to export the “raw” excel spreadsheet
• If you need to change existing data (e.g., entered the wrong subject ID, administered the wrong questionnaire), you can export the data, make your changes, and then use the “data import tool” to upload your edited data.
• You will have to design an excel template that analyzes the questionnaire data exported by RedCap. Design the template so that you can copy the subject data and, without having to edit the data, paste it into the template.
• Scoring templates and data dictionaries for individual questionnaires can be found in common/admin/measures/scoring templates.
• It is also important to share access to questionnaires so everyone can use them. To do this, first select the project to share, under applications select “User Rights”, enter the Partners ID of the person who you are giving access as ‘New user name’ and hit tab, you then select their permissions: select everything in the first third, hit Save Changes. The person you added should then receive an email to let them know.

Additional information should be added

MR Safety Screening

Section must be rewritten

• Participant must fill out MRI Safety Screening form at the interview/SCID session and at the MRI scan session
• Make sure to review MRI safety concerns with the subject, also let them know that they can end the scan at any time (squeeze ball), let them know that the scanner is very loud (make sure the earbuds are really in!)
• Have the subject remove his/her belt, any jewelry at all, anything in their hair, pockets, wrist, etc
• ALL metal (MR-safe or unknown) implants need to be checked.
• If you are acquiring documentation for technologist/Clinical Director review, you need:
  • Participant to sign a healthcare release authorizing the sharing of private health information to you
  • Surgical note from the implantation. Highlight anything in the document that could indicate a metal piece was used
  • Manufacturer’s information on the implant and whether or not it is safe at the field strength you are using for the scan (1.5T/3T/4T)
• If you know the material is MR-safe (e.g. dental work), you still need to check that the implant will not cause an artifact during scanning. You need to obtain the following:
  • Location information (e.g. ask participant to identify on dental chart)
  • Implantation information (to make sure that nothing not MR-safe is holding down the implant)
  • Review and approval from the physicist that this item in this location will not be an issue during the particular scan he or she is running (e.g. if you are scanning the liver, the dental work might not matter)
• The scanners have weight limits, but the most important thing is the size of the bore (girth of the subject is extremely important for this assessment):
  • 3T scanner
    • Weight limit: 350lbs (someone of that size has never been able to fit into the scanner)
    • Bore size: 15″ table to top x23″side to side
  • 4T scanner
    • Bore size: Inner bore diameter is 22 inches.  This equates to an inner circumference of 69 inches (maximum girth of subject successfully scanned at 4T is 52 inches).
  • Significant risks may exist for people with:
    • Cardiac pacemakers
    • Metal clips on blood vessels (also called stents)
    • Artificial heart valves
    • Artificial arms, hands, legs, etc.
    • Brain stimulator devices
    • Implanted drug pumps
    • Ear implants
    • Eye implants or known metal fragments in eyes
    • Exposure to shrapnel or metal filings (wounded in military combat, sheetmetal workers, welders, and others)
    • Other metallic surgical hardware in vital areas
    • Certain tattoos with metallic ink (please tell us if you have a tattoo)
    • Certain transdermal (skin) patches such as NicoDerm (nicotine for tobacco dependence), Transderm Scop (scopolamine for motion sickness), or Ortho Evra (birth control), or metal-containing IUDs
  • If you are unsure whether the subject has any of these items in your body, you should know that most would have been implanted as part of a surgical procedure. So, trying to have the subject remember any past operations may help. Subjects should also be asked whether you have any implanted devices or history of exposure to shrapnel or metal filings, and if so, they may not be able to participate in the study. It’s important to ask if they have ever worked with metal before, and if they have, if they wore eye protection AND if they ever suffered an injury (especially to the eyes). It’s also helpful to know if they have had MRI scans since that time.
  • MR Implant/Device Documentation Review Steps:
    • In order to scan anyone who has a metal implant or device, please follow the steps listed below.
    • Ask the PI if the implant (with the self-reported knowledge you have from the participant or the collaborator: e.g. implant location, material, previous MRIs) will affect his/her scans (based on the acquisition, voxel placement, type of scanning, etc.).
    • NOTE: For implants that are known not to be safe at 3T or conditionally safe at 3T and conditions cannot be met, subjects should be excluded.
    • Obtain the following documents to submit to the reviewer (required for review and approval)
      • Implant location, material, previous MRIs
      • Surgical note regarding the implant operation
      • Requires SIGNED healthcare release form to release the documents from the subject to the RA
      • Make/model of the implant (can be derived from the surgical note)
      • Manufacturer’s implant/device brochure
      • Manufacturer’s implant/device statement of MRI safety and previous safety studies
      • If the subject has previously had MRI scans safely with the surgical implant (anecdotal evidence not acceptable alone, but helpful to know for implant/device review and approval)
      • Check MRIsafety.com by Dr. Shellock if an implant is MRI safe. Check for any “conditions” (i.e. conditionally safe within specified SAR limit) and inform the reviewer and scanner operator of any “conditions.”
      • Coil information (e.g. transmit/receive) and body part being scanned
    • To obtain these documents, it is simplest for the subject to contact the surgeon’s office to obtain the surgical note and then forward the note to MIC staff (after having signed the release form). However, it is also possible for an RA to do so (subject would have to sign release form prior to RA contacting surgeon’s office to request medical records).After obtaining the surgical note and any other documentation provided by medical records/the subject/collaborating RA, the McLean RA should review all documentation for the following:
      • Verify where the implant is located
      • What implant was used
      • Ensure no other metal implants, clips, staples, etc. were placed during the surgical procedure.
      • (Highlight all applicable information) for implant/device review and approval
      • If this information was not already provided, contact the implant manufacturer to inquire about the MRI safety of the implant (e.g. a brochure or product information guide citing studies done at 1.5T or 3T where the implant was scanned safely).
    • It may be difficult to find information regarding 4T safety, but check Google and/or the Partners library resources.
    • To obtain approval for the scanners, forward the documentation to the following individuals:
      • For 1.5T or 3T approval, submit all documentation to Kathleen Thangaraj or any of the MRI techs. The techs may either sign off on the documentation or forward the review to Dave Olson, Clinical Director of the MIC.
      • For 4T approval, submit all documentation to Dave Olson.
    • If the implant(s) is approved for conditional scanning at 3T/4T, confirm with PI and/or scan operator that the scan will be performed within the “X” conditions.
    • NOTE: All documentation must be initialed and dated with the date of review and the reviewer. The reviewer should note whether the implant/device is safe at 1.5T/3T/4T and whether there are any additional conditions that must be met during scan.

FORP Set Up

To be supplied.

MRI Prescription Glasses

• Usually located at the 3T scanner
• Try to arrive 5-10 minutes early in order to sort these out, if needed
• Prescription ranges from 0.5-6.0 (weakest RX to be confirmed)
• Use “screen saver” wipes to wipe off your fingerprints prior to giving to the subject
• To use, simply select the RX lenses and “pop” them into the frame
• There should be an eye test sheet located near the MRI glasses case
• There is a login/logout book on the shelf above the iSCAN computer to log use

Some information is out of date or incomplete
Information about ActiCHamp system to be supplied.

The EEG system is located in our office at deMarneffe. The EEG rooms are reserved through the Google calendar

EEG Procedures

Out of date

Please review the “Working with EEG Nets” training document for additional information on net placement and care. EEG training is best done hands on. For training on EEG Analysis, please see the EEG training appendix

• During our EEG sessions, we have the main EEG room lights off, and the standing lamp on
• We also use a video camera and microphone to communicate with participants during the session. Make sure to turn on the microphone when you want it and off when you don’t.
• During the EEG session, log the name of the EEG and also note any problems (bad channels) that occurred during the session in the EEG use log (orange binder near the TV)
• Replacement supplies for the EEG can be ordered though EGI (salt, replacement nets, warranties) or small things (shampoo) can be bought at CVS and reimbursed.
• Make sure to save the EEG data on the appropriate locations on the NetStation Mac, the server, and also burn to a CD or DVD

Instructions for Participants

When scheduling an EEG session, it is important to email the participant the following information: Make sure to relay these instructions to participants before they come in for their EEG session, at least a full 24 hours in advance.

• Please do not wear any make-up during your session
• Please do not leave any hair product (sprays, gels) in your hair. Shampoo and conditioner are fine, but please make sure to rinse them out.
• Please do not style your hair.  It should be combed out as straight as possible.
• Please let us know if you have recently dyed your hair. It can discolor the EEG net.
• Please let us know if you have any head or facial piercings that cannot be easily removed.
• Please let us know if you have your hair in any of the following hair styles: corn-rows, dread locks, afro, or beehive. Unfortunately, due to the nature of these hair styles, it is nearly impossible to get good connectivity between the EEG net and your scalp.
• Let us know if you aware that you have head lice. We cannot run the EEG experiment on people with head lice due to the possibility that it could spread to future participants.
• We often find that we get the best results when the participants have recently-washed hair. If possible, if you could wash your hair 1-2 hours before the start of your session, that would be greatly appreciated. Otherwise, we should still be able to get good data.
• If you wear eyeglasses or contacts, consider bringing lubricating eye drops to the study session. Computer tasks can dry out your eyes slightly and using some drops beforehand may make the session more comfortable.

Updating Session Log Files

Enrollment Log, Subject Info. To be supplied

Downloading REDCap Data

To be supplied

Retrieving MRI Data with Osirix

Information is out of date

Osirix is the website/program that we currently use to download MRI data and to store it on the server.

• When a scan finishes, ask the tech to send the data to the “research” server
• Check the next day, or in a couple of hours on the osirix website to see if the scan is there:
  • https://mini2.mclean.harvard.edu:3333/
  • Username: latn
  • Click “study list”
  • You can download the file as a whole (works for shorter scans without multiband) by clicking the arrow next to the name
  • Larger scans may need to be downloaded scan by scan. To do this click the subject’s name, and click the arrow next to each file
  • Store the downloaded scans on the server and burn to a DVD

Results of Standard VA Brain

Information is out of date

If a subject has never been scanned at McLean before or has not had a VA brain in the past year, then they are required to have one at McLean. A VA brain is an anatomical scan that is read by a radiologist

• VA Brains take about 10 minutes to do
• You will be faxed two copies of the report; a preliminary report and a final report. It is important to file them in a locked cabinet
• In general, all PHI from a particular scan can be filed together in a locked cabinet
• Any abnormal VA brain that comes back will be reviewed by Dr. Olson. If it is serious enough, he will contact you and will discuss the appropriate way to be in touch with the participant.
• See Franzi for further details – more is required for this procedure