CHECKLIST: PI Participant File Review

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Participant Files
(Complete for sample of enrolled participants. If participant files are not accessible, disregard this section.)
Principal Investigator      
IRB #      
Study Title      
Last Approval Date      
Total # Participants Enrolled      
# Participant Study Files Reviewed      
Participant IDs
     
(list ID for each Participant File Reviewed)
Name of Person Completing Checklist      
Date Completed      
Participant Selection
Yes No N/A 1. There is a completed eligibility checklist
Yes No N/A 2. The eligibility criteria checklist includes dated signature/initials of the person making the eligibility
determination
Yes No N/A 3. For participants who did not meet eligibility (e.g. screen-failures), identifiable information was destroyed
or authorization was obtained to keep participant information
Consent
Yes No N/A 4. Pages are numbered correctly and all pages are present
5. Signatures include all appropriate and consistent dates
Yes No N/A 6. The number of participants who have signed consent forms, i.e., enrolled, is no greater than the IRB-
approved sample size/enrollment
Yes No N/A 7. Investigators obtained consent/assent from each participant prior to the start of any study procedures
Yes No N/A 8. Original copies of all consent forms/assent forms signed/dated by participants are on file
Yes No N/A 9. Validated, most up-to-date IRB-approved consent forms/assent forms were used
Yes No N/A 10. Consent forms/assent forms are free of any handwritten changes or corrections
Yes No N/A 11. The participant/participant representative signed his/her own consent forms. (Exceptions: IRB-approved
surrogate)
Yes No N/A 12. The participant's/participant representative’s receipt of a copy of the consent form is documented, e.g.,
Enrollment Log
Yes No N/A 13. If a witness signature was required, the witness signed/dated the consent form/assent form
Yes No N/A 14. If a witness signature was required, the witness entered the same date as the participant/participant
representative on the consent form/assent form
Yes No N/A 15. Consent is obtained from enrolled minors that reach local age of majority during the study
Yes No N/A 16. Waiver of the requirement to obtain consent and/or alteration of consent process on file
Yes No N/A 17. Wavier of documentation (signature requirement) on file
Yes No N/A 18. Reconsent was required and documented
Short Form Consent for enrollment of non-English speakers
Yes No N/A 19. Confirm the use of a short form is permitted for this study (Use of a short form is allowed unless
specifically stated otherwise in the Tufts Health Sciences IRB approval letter, and provided the study
sponsor allows use of a short form.)
Yes No N/A 20. Confirm no more than 5 short forms in the same language have been used in the study in a 12 month
period
Yes No N/A 21. Confirm IRB approved version of short form was utilized (a version approved and available for use on
the IRB website)
Yes No N/A 22. Confirm study specific information (title, PI, department, contact information) was typed into the short
form (this text can be inserted in English)
Yes No N/A 23. Confirm a translator/interpreter or interpreter services was utilized
Yes No N/A 24. The participant/legally authorized representative signed the short form. (Exceptions: IRB-approved
surrogate)
Yes No N/A 25. The witness signed, dated, and printed his/her name on the short form (the witness may be staff,
translator/interpreter, family member, or another person not on the research team)

Yes No N/A 26. Name of translator: was noted on the short form
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Yes No N/A 27. The PI and witness signed the long form ICF.
Data Collection Source Documents
Yes No N/A 28. Data collection complete/accurate for each participant. (e.g. no blank fields/missing data)
Yes No N/A 29. Source documentation is available to support data entry
Yes No N/A 30. The source documentation/CRF for each participant includes dated signature/initials of the person
obtaining the information for each participant
Yes No N/A 31. Changes/cross-outs, additional comments (if any) in participant files routinely initialed and dated
Yes No N/A 32. For any changes/cross-outs being made, the original entry is still legible. (e.g. use of white-out or pencil
erased entries is not acceptable)
Yes No N/A 33. Access to on-site research records is restricted to delegated and trained personnel
Yes No N/A 34. Access to on-site electronic research data is restricted as applicable, to delegated and trained personnel
Self-Assessment Review Summary & Recommendations. Describe each “No” check above, referring to the point #: