Orientation: Set up and Trainings

This section of the training manual focuses on getting you fully integrated into the laboratory and the Partners network. It is roughly organized from highest to lowest priority tasks, all of which must be completed before you can fully start work as an RA. You will likely split some of these tasks with other RAs to facilitate this process.

Day 1 Instructions for New RAs

Every new RA arrives eager to get started, but first there are a number of hurdles to get over. There is a 1-page version of this checklist in the common/RA-Training folder.

Set up Accounts and Email

Activate your Partners User ID

You must do this step first. You will use your Partners ID to access your email, log into PeopleSoft, and to manage the IRB for studies you are in charge of. Before you can set up your 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 tell you your Partners User ID, and you will choose a password and some challenge questions. Your password must be at least 8 characters long and have letters and numbers.
4. Your Partners User ID will look like your initials followed by a number (such as “dap47”). You will use this Partners User ID to log in to all Partners systems such as email, PeopleSoft, and Insight.

Verify your Email

1. Visit www.partners.org/email and log in with your new user ID and password. If it works, 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 easiest way to find out what your email address is, is 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 can (and should) also have a ‘@mclean.harvard.edu’ address. Unless there is a specific reason to do otherwise, use your McLean email address for all correspondence.

1. To activate the McLean address, submit an IT 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).
2. Your McLean address will have the same username as your partners.org address.
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 mailbox. Mail sent to either address goes to the same place.

Set up your Jupiter account

CDASR has a server called “Jupiter.” All study data, IRB protocols, recruiting resources and anything else CDASR-related, as well as all your personal work files, are kept there. Jupiter is in the MIC data center and is managed by the MIC-IT team (Chrissy Bonello and Jesse Baer). They will create an account for you and set it up with access to the directories and files you’ll need to do your job.

1. You’ll receive an email from the system administrator when your account has been created, with instructions for how to access the account. The account name will have an initial and your last name, often the same as your email name.
2. Refer to the “Jupiter_Server_Setup_Instructions” document for information about setting up the password for this account.
3. Those instructions also explain how to connect to the network drives from your PC.
4. You’ll also be added to some group distribution lists such as mcl-latn, mcl-cdasr, and mic-plus.
5. If you have any problems with Jupiter access, contact Dave before reaching out to Chrissy and Jesse.

Security Requirement: Every lab member is given an individual account on Jupiter. You must only use your own account, and you must not share your account with anyone else. If you are using a shared computer such as a workstation on the countertop, you must Log On at the beginning and Log Off at the end of every Windows session so your connection to Jupiter gets closed properly.

CITI Training

Human Subject Protection training is mandatory in order to interact with study participants and must be completed before you can be added to the study staff for any project. You have to wait until your email address is activated, and use that address when you register.

1. 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. If not, you can use your partners.org address.
2. 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).
   • This should enroll you in the “Biomedical Research – Basic” course.
3. Complete all of the modules listed.
4. When you complete the CITI training, download a PDF copy of your certification and email it to Dave. Inform the other lab members you’ll be working with that you’ve completed the training.
5. Within 24 hours, your status will be updated on the Insight system, allowing the other RAs to submit amendments to add you to the study staff. You will receive a confirmation email directing you back to Insight to provide your approval.

For 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.

Set up your Google Calendar

All 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

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

If you already have a personal Google calendar that you want to keep private, you can create a second calendar that’s just for lab appointments following these instructions: https://support.google.com/calendar/answer/37095?hl=en.

Set up your Phone

Typically you will inherit an extension from a previous RA, or one will have been installed before you arrive. If you’re inheriting a phone and you need to clear the previous owner’s voicemail and password, contact Communications Services (x2113).

Voicemail Set-Up

To set up your voicemail, press “Message” button on the phone, or dial 3660.

Enter your 6-digit password. Traditionally the default password for new accounts is “mclean” (325326)

Once password is entered, press #4 for Main Menu – Personal Options

Greetings – press #3

Change personal greeting – press #1

Change recorded name – press #3

Follow directions accordingly.

Don’t forget to update your entry (phone and email) in the Partners Telephone Directory (ppd.partners.org)

Accessing your voicemail

There are three way to access your voicemail.

Most office phones have a button labeled “Message” that connects directly to your voicemail

Dial the extension 3660 to connect to voicemail

From outside the hospital you can access your voicemail by dialing 617-855-3660.

How to Dial Internal and External Calls

Within McLean, dial the four digit extension.

Calls to area code 617: to call numbers in the 617 area code, dial 9 to get an outside line then 1, then the number. So to reach Mike’s Pizza in Belmont, dial 9-1-617-484-0130.

Other area codes: To call any other area code, dial the access code 165986 first, then 9, then 1 and the number. So to reach P&J’s Pizza, dial 165986-9-1-781-484-6136.

To reach a McLean extension from off site, dial 617-855- and the extension. If you don’t know the extension, call the main number at 617-855-2000 and they will transfer your call.

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; calls using this access code are audited every month.

Training Checklist

There are a number of external 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 MRI safety training, and pass the test. This will allow you to gain access to the MIC and scanning rooms, and 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.

Robert 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 and eCheck Training

eBuy Training

You will use E-Buy quite frequently to purchase items for the lab. View the training schedule at

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.

E-Check and Expenses Training

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.

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.

About once a year, people from the IRB and the QI Program at Partners offer a seminar at McLean. Contact Dave to find out when the next one is scheduled. The Partners QI Program provides information about regulatory binders on their website at https://partnershealthcare.sharepoint.com/sites/phrmdepartments/poc/qi.

Week 1 Items for New RAs

The following tasks should be done within the first week on the job.

Set up Outlook on your PC

Add a signature to the end of your email

To set up Outlook on your work PC, contact Dave

We also have a shared mailbox for recruitment: neurolab@mclean.harvard.edu

PeopleSoft-HR and Benefits Updates

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.

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

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

You should 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).

Keys

You will need the following keys:

Your office key

KB3: Opens the main door to the CDASR area, EEG rooms, and Behavioral Testing Room

A key to your desk and the file cabinet in your office.

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

In most cases these keys will be ready for you when you arrive, passed down from your predecessors. If needed, ordered keys using the Facilities Work Order form: http://phsmclgpm2/GpmWoRequest.aspx. It usually takes a week or 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.

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

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 additional keys must be approved by Terry Mancini, at the MIC.

Useful Contacts and Websites

Useful Contacts

Refer to the file “Useful Contacts and Links.doc” for updated information: Z:\common\Admin\Center_Directory_and_McLean_Contacts

Useful Websites

McLean Sites

McLean General Website http://www.mcleanhospital.org/

McLean Research Website: https://research.mclean.harvard.edu/ (mostly obsolete)

McLean Intranet “Brainwaves”: https://mclean.partners.org

Partners Sites

During 2016, most Partners web sites are being completely redesigned, so many of these URLs may become obsolete. Many new sites rely on Office365 for security, and this frequently requires multiple logins and leads to difficulty following links. It’s not your fault!

Office 365 Login: When you see the Office 365 login screen, enter your email address and press OK. A password is not required on that screen. You will be redirected to a standard Partners login screen.

Partners Intranet “PartnersPulse” http://pulse.partners.org

Partners Phone Directory “PPD” http://ppd.partners.org

Supply Chain (formerly Materials Mgmt) http://supplychain.partners.org

Research Computing http://rc.partners.org

Research Navigator https://partnershealthcare.sharepoint.com/sites/phrmportal

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.”

All of the central research organizations such as the IRB, Research Finance, and Research IS have moved their web sites into the Navigator portal. There is a public side, accessible without logging in, and a private side that has all the useful information.

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/

Web-based 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

Main website: http://cdasr.mclean.harvard.edu/

LATN Recruitment website: http://www.mcleanstudies.org/

Recruitment survey (for lablab) http://www.mcleanstudy.org/

General Lab Administration

Arranging a Meeting or Event

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. The coordinator’s responsibilities are:

Review the program of speakers and book the Academic conference room for every date.

We book the room, order catered food (tip: mini muffins sound good, but don’t taste as good as the big ones!), confirm the speaker in advance, announce the seminar, and make sure the projector works.

See “Z:\common\Admin\SpeakerSeries\CDASR Speaker Series” for separate document with instructions and email templates. You can also find the catering order forms here.

Booking Conference Rooms

The BrainWaves page at https://mclean.partners.org/departments/administration/conferenceRooms.aspx provides most of the information you’ll need, for all conference rooms. Each conference rooms has an Outlook Calendar, on which you can check availability. These are in the Folders section of Outlook:

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

Hint: drag the rooms you’re interested in to your Favorites folder so you don’t have to follow this path next time.

The Contact Caroline Rotondi (deMarneffe 214, x3145, CROTONDI@PARTNERS.ORG) for booking conferences rooms in deMarneffe and for posting events on McLean Brainwaves.

Contact Mary Beth Traynor (x3581) for booking other conference rooms (e.g. Pierce Hall, Putnam Room, etc)

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

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.

A sample catering order form for the CDASR speaker series is also in common/Admin/SpeakerSeries. Fax to Dot at #2658 at least 48 hours in advance.

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 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 information and 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 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

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

Go to brainwaves for links to public affairs related issues: https://mclean.partners.org/departments/administration/businessDevelopmentMarketingPublicAffairs.aspx

To put your poster up on the video displays in the deMarneffe lobby and cafeteria, contact Caroline Rotundi.

Holiday Functions/Center-Wide Events

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 materials management, who are responsible for monitoring the corporate cards (mmcorporatecard@partners.org). 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.

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 so was underattended. There was plenty of room, but it was a little weird because it was basically at a 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 (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

Facilities Work Orders

You will submit these online for many different things: temperature issues, new shelves/small construction projects, new keys, emptying recycling and CINTAS bins, emptying biohazard bin, urgent cleaning issues, etc

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

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).

Remember to put it outside of the EEG control room so that it can be picked up.

Fresh towels go 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: Michele.Holbrook@dtz.com

Housekeeping

Contact building services x2656

Also, contact Roges Gedeon at x2619 for any persistent/urgent issues

Miscellaneous Administrative Tasks

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)

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. 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/scripts/phsweb.mwl?APP=PDPERS&ACTION=JUMPMAIN

You can also use the paging service here for paging a study doctor

Update you own location, extension, and job title here. This flows into the Exchange global address list.

Paging within Partners

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

Lab Websites

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 is http://www.mcleanstudies.org/.

The site is hosted at wix.com, with an annual renewal fee of about $125.The Wix 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.

Booking Travel

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

This link will have further information on Egencia (see below), including how to make an account and also general Partners policies.

Egencia

Booking through Egencia is like booking through Expedia, except you need to log in. You create a username and password, and Diego needs to delegate that you can book his travel.

Egencia website: https://www.egencia.com/pub/agent.dll?qscr=logi&&zz=1156430977699&nojs=1&dchg=

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.

Purchasing and Finances

General Finance

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.

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

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

Where the money comes from: Grants from the NIH come in many shapes and sizes, and have designations such as R01, R21, K01, K23, UH2, as so on. In addition, Investigators sometimes receive project grants from external foundations such as BBRF (NARSAD grants), and the Dana foundation. There are also internal grants awarded within McLean, such as the Kipplinger award.

Tax Exempt Form

McLean Hospital is exempt from Massachusetts sales tax. When purchasing outside of PeopleSoft or a purchase order, it is important to make sure the vendor does not add a sales tax. Some online vendors will require that you contact them by phone to order.

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

You can also enter the number into the comments section when ordering from PhD posters.

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.

Managing and Filing Financial Paperwork

Cost centers and credit cards can be found at common\confidential\passwords

General Filing

IMPORTANT: log all spending in the expenses log: common/confidential/expense_tracking/Expenses.xlsm

If you spend any money, it’s up to you to keep the records. Each expense that is charged by an RA will need to be filed in his/her filing cabinet.

It is up to you to decide how to organize the files, however here are some tips

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

Subject payments records are PHI and must be filed in a LOCKED cabinet the with other PHI in the corridor.

Monthly Review of Expenses

Each month, Janice will email a copy of all of the expenses charged to Diego’s grants.

You should check all the items that are charged to your studies, to make sure you recognize them and the amounts are correct.

Check all subject payments to make sure you’ve been billed correctly

Sometimes Fed-ex charges appear without anyone knowing where they are coming from. Note that the requisition/PO number should be the same for the S&H charge and for the order itself. Try to figure it out, but this happens often, and Janice is used to dealing with it.

If a charge seems odd, and no RA has claimed responsibility, alert Janice

When you have indicated all of the charges you are responsible for, email Janice

Transferring between Funds

Sometimes you will need to make a purchase on a different fund than the one you want it charged to. Examples of this would be when the EMBARC fund was waiting on a new fund number, we charged the supplies to the Sundry fund and transferred the money later

When doing this, always use a sundry fund as the temporary source. it is much harder to transfer an expense off an NIH grant (R01 fund).

Notify Janice when you make the purchase so that she knows to keep an eye out for when it hits the funds. Janice will then submit a journal entry to transfer the charge.

You can also split purchases as well. If you only want 50% of the item charged to the Sundry, 50% to the R01 etc.

Supply Chain Systems

Website: supplychainpartners.org
Client Services help desk: 617-726-2142

Supply Chain Management (SCM, formerly called Materials Management) is a Partners organization that covers many central corporate functions including purchasing, accounts payable (A/P), contracts, and vendor management. Most importantly for us, they provide the eBuy system for creating purchase requisitions, and the eCheck system for processing subject payment. You would also contact SCM with credit card concerns.

The Client Services Helpdesk is probably the most helpful helpdesk you will ever encounter, so call them whenever you have a problem at 617-726-2142.

• If your subject complains that they haven’t received their check, call Client Services. They can look up when the check was sent and whether it was cashed. If the check was lost 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.

Access and Training for eBuy, eCheck, and Expenses

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

• The table below offers general information about each module and how to obtain access and training for each system.
• Access can be obtained via a self-enrollment page within PeopleSoft. Click for more information.

PeopleSoft Module	How to Get Access	Training Information
eBuy+ is Partners’ online requisitioning system for requesting goods and services.	PeopleSoft eBuy Requester Access Form must be completed and signed by manager. Click for more information.	eBuy+ Training is required before you can obtain access to the system. Both classroom training or web-based training are available.
eCheck is Partners’ online check request system for requesting that an individual or supplier be paid.	Access can be obtained via a self-enrollment page within PeopleSoft. Click for more information.	Training is strongly suggested, but you do not need to attend training before getting access to eCheck. Click for more information about our training options.
Expenses is Partners’ online system for requesting employee reimbursement for out-of-pocket and corporate card expenses.	Access can be obtained via a self-enrollment page within PeopleSoft. Click for more information.	Training is strongly suggested, but you do not need to attend training before getting access to Expenses. Click for more information about our training options. Corporate card users may also participate in supplemental training on reconciling transactions in Expenses.

Purchasing using eBuy

eBuy

To make a purchase, go to PeopleSoft then navigate to Financial Production > main menu > eProcurement >  Create Requisition

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.xlsm file.

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: $93.46

Urine Drug Tests: do a special item order 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
  • in item type, search for ‘lab’ and select ‘general lab supplies’

Toner/Ink: Order through the Staples web function

• • For black & white printer: Diversity Products Solutions by Staples™ Remanufactured Toner Cartridge, HP 38A (DPS38AR), Black, Staples Item # 554967
  • 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!

Note regarding purchasing software: Dave is in charge of this, so ask him first with any questions.

Paying an Invoice

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).

Create a purchase order for the invoice in eBuy:

Define Requistion

• • Vendor: look up vendor
  • 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

eCheck

eCheck is the system you will use to send payments to subjects for study visits.

Training: http://pulse.partners.org/services/training_echeck.htm

To submit a subject payment, refer to the check request form that the subject filled out at the study session

Login to PeopleSoft

Navigate to: Financial Production/Accounts Payable/Vouchers/Add/Update/ Regular Entry

Fill out the “gross invoice amount” with the amount the subject will be paid. Click “Add”

Fill in the subject’s information under the “single payment vendor” tab. If do not have a SSN, enter “foreign” in this field.

Click on “invoice information”. All you need to fill out is 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

You do not need to fax the receipt anymore

Store the document in file cabinet

Fill out the appropriate subject payment documentation log (under common/confidential/)

Issues, contact Partners Materials Management: 617-726-2142, option 3 (also call here if need a to know status of a check)

Cathy O’Connell is in charge of both E-Check and E-buy trainings. She is also a great resource for any questions about reimbursements, check requests, expenses or petty cash.

Payment Problems

To Be Supplied: Types of problems, how to follow up

Expenses

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

Training: http://pulse.partners.org/services/training_expenses.htm

Diego will name an RA as a delegate within the system so that you 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:

Note: some of these instructions are obsolete. Refer to the e-Expenses training material 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

Petty Cash

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

Items needed to request a Petty Cash set-up

Check Request

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

We have usually requested a larger check with enough money to run a number of participants

To fill out the check request, begin 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: 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”
  • Save and fax

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 sometimes she forgets, so 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 and the monies can be paid to the subjects.

Make sure to keep a record of the subject payment

• • Fill out an excel document with the date, amount dispersed, and the name of the person who dispensed the money to the subject
  • Also, have the subject fill out the Petty cash record sheet with their name, the amount dispensed, and their signature. File this record in a secure location

When requesting more money, you must attach a copy of the subject payment record so far, complete with an indication of when the last petty cash check was received, and the number of subjects who receive money from the previous check.

The receipt should stay in records for a period of 3 years after the close out of the study

Credit Cards

Diego has three corporate credit cards (LATN Sundry, ELS, RDoC).

Dave manages the credit cards for the lab.

Specific information about each card can be found in the Common/confidential subfolders

Sometimes the card will get declined because a purchase isn’t on the list of ‘approved’ purchases. Sometimes this will happen paying for taxis, or some online equipment purchases.

You need to email mmcorporatecard@partners.org to get approval for the purchase. Usually they are pretty reasonable, but a little slow with returning emails. They will ask you to email when you have purchased the item so that they can remove the allowance again

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

Ordering Supplies through a Vendor’s 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 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. Other times, software can only be purchased this way, or permissions to reproduce images in papers
• Do this in the same way that you would usually order something online.
• The Corporate Card Management department reviews all credit card spending. If you know this is a big ticket item, or it is not obviously related to academics (i.e not society membership, poster printing, or travel related), 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.

Other purchasing

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 (Scott.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 though Rittenhouse: call +1 (800) 345-6425 and use acct # 012959 – we get a 17% discount with them. For questions contact Josephine Amico.

Independent Contractors

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

Recruiting

Overview of recruiting

Privacy and Confidentiality

Lablab

An entire section of lablab information

Recruiting Methods

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

Online Recruitment Survey

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 Advertisement Postings:

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!

Clinical Trials at Partners (http://clinicaltrials.partners.org/Main.aspx)

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 on common/confidential/passwords

Paid Advertisement

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/

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.

Phone Screening

When you contact a potential participant, or they contact you, be sure to follow the correct procedure. See the procedure outlined in Lablab and supporting documentation, located at Y:\common\Participants

Lab Suicidality Procedure

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

Again, for further instruction, please see common\participants\Phone_screening_materials\Suicide assessment and prevention materials

Eligibility

LATN standard criteria

Assessment of mental health

Assessment of Drug Use

Study-specific Eligibility Criteria

Running a Study

IRB and Protocol Administration

Regulatory Binders

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 for details http://www.partners.org/phsqi/vrb/files/index.htm#. 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

1. 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.
2. Licensure:
   • Valid licenses for all licensed professional study staff
   • Human subject protection training document (CITI training)
   • Medical licenses for the study physicians
3. 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
4. IRB:
   • Copies of all signed and dated IRB submissions
   • File in reverse chronological order (most recent first)
5. Consent Forms:
   • File all copies of originally stamped consent forms (should have red stamp)
6. 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 update the study staff to make sure that there are no expired CITIs

You can also submit an amendment with the CR, either a study staff or a regular amendment.

• • When you do this, you submit all of the documents that are altered in the amendment, and then only submit the unchanged documents with the CR.

Diego likes to review all CRs before you submit them to the IRB

Cede-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/

Investigational New Drug (IND)

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\Human_Subjects_IRB\_McLean\McLean_Protocols\IND_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

ClinicalTrials.gov

Creating a REDCap Survey

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 administer. 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. This is slow, but is usually done when making a new questionnaire.

Study Drugs and Supplies

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. RA’s 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

Ordering eartips and tubes for LowMood EEGs

Order at http://www.etymotic.com/ (accepts credit cards)

Replacement tubes: ER1-06 Single Use Eartips™ adapters with tubing ($13.50)

Eartips: ER10D-T08 8mm Single Use Eartips ($30)

Running Study Sessions

Arranging a Session

Scheduling

Google Calendars

Here is a list of relevant google calendars that all RAs should have or request access to as of June 2016:

Clinicians:

Lynn Alexander

Mei Hall

Laurie Scott

Nancy Brooks

Laptops:

Dell

Pizzagalli Laptop (Asus)

Macbook Air

Large Lenovo

Small Lenovo

Testing Rooms:

Behavioral Testing Room 237

Control Room (235/236)

Experiment Room 243

227 Testing Room

228 Testing Room

Other than this, you can request access to other postdoc/RA calendars on an as needed basis.

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

For Clinical SCIDs, book 2 hours.

For HC SCIDs, book 1 hour.

If you have additional measures, or the subject has a particularly complicated history, you may need to book more time.

Be sure to leave clinicians at least 30 minutes free for lunch around the middle of the day.

ALWAYS reserve laptops on the gcal when you use them. Do not take a laptop without reserving.

It is your responsibility to leave an experiment room on time if another session is booked immediately after yours.

Study Doctors

Booking Rooms at the MIC

To book rooms for sessions at the MIC, use the website 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 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.

Status sign for each testing room should be changed to reflect current status; i.e. “vacant’ should be displayed after leaving the testing room.

There are four testing 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). These rooms are used for REW22, REW21, and ELS studies

There are also 4 exam rooms that can be booked for labwork and MRI scan sessions:

3T: must email the people who are using the scanner at this time to make sure they aren’t using it. It is the best room to book for REW22/trauma MRIs. Should be the second choice for bloodwork because it is the only other exam room with a table for ECG. You will need to get the ECG from the 1.5T exam room. The internet is the best in this room. Wi-fi signal is great

1.5T: Internet is not great here. Sometimes you can get wi-fi, and the Ethernet hookups are difficult to access. This should be your first choice for bloodwork/ECGs because the ECG is there and the bed has the best set-up.

4T: This is the exam room that is used the least. A blood draw could be done here, but not an ECG. There is a centrifuge here for spinning blood. The freezer for saliva samples is here.

MIC exam room: This is the room next to the 3T. 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. Used for MIDAS.

For MRI scans, book any exam room with a bathroom (for urine drug/pregnancy testing)

Subject Transportation

Transportation requirements and options

Public Transportation

73 Waverley Bus; Commuter Rail

McLean Shuttle

McLean has a shuttle that you can arrange to pick subjects up and bring them to McLean from the Waverly bus stop. The schedule is online at http://www.mclean.harvard.edu/about/directions/shuttle.php

If the subject needs to be picked up outside of the rush hour times, call security 2121 to arrange the pick up

Taxis

*As of 2015-2016, 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, if taxi use is 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.

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

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)

Updating Logs and Spreadsheets

Enrollment log, subject info, lablab

Common Session Procedures

Informed Consent

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

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.
  • Quest specimen pick-up box is located in the foyer of the MIC. 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

Administering REDCap Suveys /Data Entry

To administer a survey to a participant:

• • 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”

Another method to administer a survey:

• • 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).

Another option is to 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.

Session Data Management

Updating Session Log Files

Enrollment Log, Subject Info

Downloading REDCap Data

Retrieving MRI Data with Osirix

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

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

Running an MRI or PET Session

Requesting MRI Scans

You may also need to request a development scan to test a new scan, or task in the scanner. You do not get charged for development scans, but you need to request and get approval for them ahead of time. To request development scans, get a Blue Sheet from Diane Zilonis (Dr. Lukas’s assistant). Blue Sheets are also required to set-up new MRI studies. The Blue Sheet needs to be filled out, signed by the PI, signed by Dr. Lukas, and brought to Kathleen Thangaraj. Development scans also have their own consent forms, which you can get from Wendy Tartarini at the MIC.

In addition, 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 becomes available on the calendar. If you do not have a subject booked for your reserved time slot 48 hours in advance, the time will be released as “open time” and anyone can 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 Developmental Scan

You must fill out a ‘blue sheet’. These are kept in the supply/copy room at the NIC.

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.

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 (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.

PET Rooms and PET Scans

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 room for the PET scan:

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

MRI Tips

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

MRI Safety Concerns

MR Safety Screening

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.

Running an EEG Session

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

EEG Training

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

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.

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 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.

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.

For training on EEG Analysis, please see the EEG training appendix

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

New Topics 2016

McLean Seminars and Training

CDASR and MIC seminars,

External training: CITI, Healthstream, MRI Safety, eBuy webinar, Phlebotomy, Radiation Training, Martinos Center training

Information Systems

Orientation

Systems, Accounts, Departments

CDASR Computer Resources

Section to be supplied:

Jupiter Server, file structure, access, Common resources

MIC systems: Calcium

Google Calendars

File sharing, Syncplicity

IS Topics

Information Security

Section to be supplied

Remote Access, VPN, OWA

Printing

We mainly use the black and white printer and the color printer located outside of the cubicles.

The larger laser printer (name: XRX…PCL6) only prints black-and-white, however it is very fast and supports two-sided printing, which you should use whenever possible.

The smaller printer (name: HP officejet pro 8500…) supports color

Dave is responsible for ordering new cartons of paper when the supply runs lower than 4 reams. Let him know if you notice paper is low.

Dave is also responsible for ordering replacement ink and toner. Let him know if you see a message about low levels.

Faxing

The smaller (black) printer is also a fax machine.

Our fax number is 617-855-4231

To send a fax, just dial the number then press “Black Fax” on the keypad

To fax inside the hospital just dial the 4-digit extension

Remember to dial 9-1-617- for local calls

To fax outside the “617” area code, dial the access code 165986 first, then 9-1- and the number

Copying

Use the large printer outside the Academic Conference Room (#218) for large copying jobs

You must key in our code number “4230” (Diego’s extension)

This machine can also scan a document to PDF and send it to your email address

You can set up a username as a shortcut for yourself, rather than keying in your whole email address

Printing at the Mailroom

Sometimes there are printing jobs that are too large for the CDASR printer to handle. The best example of this is the SCID. For these jobs, the mailroom makes copies for us.

There is a form at the mailroom you will need to fill out. Put the fund number, and also indicate the number of copies, double sided etc. Max, who manages the mail room, is very helpful for filling out these forms.

The mailroom also has copies of various forms we use: order forms for medical supplies, taxi vouchers, McLean letterhead and envelopes.

Corporate Information Systems

Section to be supplied

PeopleSoft, Insight,

Navigator, Brainwaves,

Obtaining Hardware and Software

Lab Software

Dave is responsible for managing the software licenses for the lab. CD/DVDs of software are kept in binders in locked storage cabinet #1 outside of the cubicles. Chrissy Bonello can also help with purchasing software. The main software that you will be asked about are Matlab, SPSS, and Eprime.

Information on Software, including copies of installation files and license codes for some programs, can be found at common/software

In addition, licenses, websites and log-in information for software can be found at common\confidential\Passwords\Passwords.doc

Matlab

Matlab is managed through the company Mathworks

We have a server license that allows multiple people to use this at once

We also have a couple of individual licenses

These can be managed online: http://www.mathworks.com/

There are licenses on the Dell, Asus, and Macbook laptops

E-Prime

E-Prime is what most of our scripts are programmed in for our studies

E-Prime has two progams:

E-Studio is used to design, create, and test scripts. To run it you must plug a HASP into your USB port (this is a thumbdrive that contains the license)

E-Run is used to run the script. E-Run is installed on all the laptops and does not require a HASP. Note however that the laptops have different versions of E-Prime

When you open E-Run, you press F7 to start the task. A subject number of 0 will not save the file

There are a number of versions of E-Prime (E-prime 1, E-Prime 2.8 and Eprime 2.10)

The HASP USB sticks kept in the safe that have E-Prime 1 or 2 on them. It is important to sign these out if you are using them, and for them to be returned to the safe asap. Our license # is also located on the package of the dongles, you may need this to register e-prime on a new computer

Because the computers have different versions of E-Prime on them, certain tasks can only be run on certain computers currently. Before running a subject, make sure you have the right computer to run all of the tasks

Microsoft Office

We now get Microsoft Office 2013/2016 free from Partners. Before you can install it, you must submit a request to the IT Helpdesk asking to be signed up for Office. They will enable your account on the Microsoft portal and send you directions for what to do next.

Copies of older Microsoft Office installation discs are in the Software Binder in one of the storage cabinets.

Net-Station

This is the program used to record EEG signals. It is on the Mac in the EEG control room

Sigdet Analyze

This is the program that analyzes Diego’s Sigdet task (AKA face game or PRT task). Training for this is located at common/scripts/Sigdet training

Brainvision and EEGscore

These are the processing streams that we use to analyze EEG data. Training for these programs are located at: software/brainvision/brain vision manuals

Files Referred To

Appendixes are listed by title, but are actually in separate files in the RA_Training_Modules folder.

Day_1_checklist for Employees

Useful Contacts and Links

Jupiter_Server_Setup_Instructions

LATN Information Security Policy

Et Cetera