Managing a Study

IRB and Protocols

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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

 

REDCap Surveys

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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.

 

Study Drugs and Supplies

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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