How-To

Scheduling a Session

ChopShop

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

Google Calendars

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

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

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

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

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

Observe the following guidelines when reserving time:

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

Booking Study Doctors

To be supplied

Booking Rooms at the MIC

Some information is out-of-date.

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

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

Scheduling MRI Scans

Some information is out of date

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

Requesting a 3T slot for a study session

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

Reserving the 4T for a study session

To be supplied.

Requesting a Developmental Scan

Out of Date

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

Scheduling PET Scans at MGH

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

To book a PET scan:

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

To book a testing room for the PET scan:

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

 

Study Drugs and Supplies

ChopShop

Investigational New Drug (IND)

Out of date information:

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

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

Pharmacy

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

Setting up a study with the Pharmacy

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

Ordering new drug for a study

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

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

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

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

 

REDCap Surveys

ChopShop

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

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

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

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

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

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

 

IRB and Protocols

ChopShop

Regulatory Binders

This section needs to be changed to reflect LATN standards

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

All regulatory binders should include:

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

Insight

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

 

Amendments

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

Study Staff Amendments

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

 

Continuing Review

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

Ceding Review to Another IRB

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

 

Petty Cash

ChopShop

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

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

Requesting a Petty Cash set-up

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

Check Request

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

Cash Handling

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

Payments and Records

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

 

Some specific purchasing exceptions

ChopShop

Poland Springs Water

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

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

Here is a sample email:

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

Ordering Books via Rittenhouse

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

Independent Consultants and Contractors

Out-of-date

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

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

 

Credit Cards

ChopShop

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

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

 

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

Ordering Supplies or Services through a Website

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

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