Self- Assessment FAQ

    1. What is an Investigator Self-Assessment?
    2. Is the Investigator Self-Assessment required?
    3. Where can I find a copy of the Investigator Self-Assessment?
    4. To whom can I send my completed Self-Assessment?
    5. Why should I complete an Investigator Self-Assessment?
    6. How was I chosen to complete an Investigator Self-Assessment?
    7. I completed a Self-Assessment within the past year, why did I get an invitation to complete another one?
    8. How do I complete an Investigator Self-Assessment?
    9. Do I need to have CVs on file for everyone involved in the study?
    10. When the Self-Assessment refers to “study correspondence,” what does it mean?
    11. Where do I get a copy of the IRB Roster?
    12. What is an FWA and where can I find it?

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1. What is an Investigator Self-Assessment?

The Investigator Self-Assessment is a checklist that can be used to assist researchers in maintaining and organizing study documentation (i.e., regulatory documentation and participant files) and ensuring compliant study practices.

2.Is the Investigator Self-Assessment required?

The Investigator Self-Assessment is not required; however, QIP periodically selects, at random, protocols for which a Self-Assessment is recommended. Completion of the Self-Assessment at that time is still voluntary. The intention in collecting assessments is not punitive; but rather an effort to assist investigators, learn how best to respond to investigators’ needs, and to document internal monitoring activities.

3. Where can I find a copy of the Investigator Self-Assessment?

The Investigator Self-Assessment can be found at https://www.hsph.harvard.edu/ohra/qip/study-management-tools/

4. To whom can I send my completed Self-Assessment?

To receive a confidential customized report including corrective actions and/or best practice recommendations, email your completed Investigator Self-Assessment to qip@hsph.harvard.edu or any member of the Quality Improvement Program (QIP) team.

5. Why should I complete an Investigator Self-Assessment?

The Investigator Self-Assessment serves as a guide to assess whether your regulatory documentation and/or participant files are complete and well organized. The purpose of the Self-Assessment is to provide an internal gauge of compliance. If you would like a customized report back from the QIP team, including corrective actions and best practice recommendations, send along a copy of your completed Self-Assessment to qip@hsph.harvard.edu. This report will not be shared with the IRB as it is intended as a tool for the study team.

6. How was I chosen to complete an Investigator Self-Assessment?

This year QIP is selecting a random sample of all non-exempt human research protocols that received initial approval between July 1, 2013-June 30, 2014 for the Investigator Self-Assessment initiative. The criteria changes for selection every fiscal year.

7. I completed a Self-Assessment within the past year, why did I get an invitation to complete another one?

Protocols rather than PIs are selected for Investigator Self-Assessments. Please keep in mind that the Investigator Self-Assessment checklist is a voluntary quality improvement initiative meant as a useful study monitoring/record keeping tool. The checklist should be quick and painless to implement, especially if study records are in good shape. Regardless of whether QIP selects a protocol for Self-Assessment, you can access the current Investigator Self-Assessment tool anytime and “submit” the results to QIP for a report. In fact, this may become part of your study monitoring process, which could be implemented regularly to ensure compliance.

8. How do I complete an Investigator Self-Assessment?

Review your Regulatory Documentation using the Investigator Self-Assessment. Simply check off which documents you are currently maintaining in your research files. Once complete, if you would like to send your Self-Assessment to QIP, they will provide you with a customized report including corrective actions and best practices. The report is kept confidential from the IRB and shared only with the HLMA PI and person who completed the Self-Assessment (if separate).

Is your project a clinical research study?
If your study involves clinical research (including IND or IND studies), please also complete the Clinical Research Addendum of the Investigator Self- Assessment. Answer all questions as they pertain to study documentation maintained in your regulatory files and provide confirmation of your study conduct.

Does your study have participant files kept on-site?
Complete the Participant File Assessment page of the Self-Assessment only if you have direct access to participant files, e.g., they are stored locally and/or easily accessible virtually/remotely. Feel free to have study staff who maintain participant files on-site complete the checklist if desired. It is not necessary to review every participant file for the purposes of this self-assessment. QIP recommends randomly sampling approximately 10 participants’ files, though you are welcome to review more at your discretion.

9. Do I need to have CVs on file for everyone involved in the study?

It is best practice to have CVs for every staff member covered under the HMS/HSPH/HSDM IRB on file with your Regulatory Documentation. If kept separately from your regulatory files or in electronic files, write a note to file indicating where the CVs are kept. As part of best practice, CVs should be updated, signed, and dated every 2 years. Updated CVs must be maintained when a protocol is required to follow Good Clinical Practice Guidelines.

10. When the Self-Assessment refers to “study correspondence,” what does it mean?

When the Investigator Self-Assessment uses the term “study correspondence” it means (significant) emails, phone logs, and/or letters relevant to the study and its review.

11. Where do I get a copy of the IRB Roster?

Email qip@hsph.harvard.edu and they will send you a copy of the current HMS/HSDM or HSPH IRB Roster for your records.

12. What is an FWA and where can I find it?

An FWA (Federalwide Assurance) is the assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under an FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR part 46, as well as the Terms of Assurance (http://www.hhs.gov/ohrp/policy/faq/assurance-process/what-is-fwa.html).
If your study was approved by the HSPH IRB: FWA #00002642
If your study was approved by the HMS IRB: FWA #00007071