Is an IRB member roster present and ☐ ☐ ☐ ☐ up to date? Is an FWA present and up to date? ☐ ☐ ☐ ☐ Has a final protocol closure report been submitted to regulatory ☐ ☐ ☐ ☐ authorities and filed appropriately (if applicable)? Informed Consent/HIPAA ☐ Not Yes No N/A Notes Authorization Forms Reviewed Are all versions of the IRB approved informed consent/assent present and ☐ ☐ ☐ ☐ filed? Are all versions of the IRB approved HIPAA Authorization(s) present and ☐ ☐ ☐ ☐ filed? Are all versions of the IRB approved information sheets present and filed ☐ ☐ ☐ ☐ (if applicable)? TIP: Tracking/version history logs are often used to track informed consent versions approved with corresponding IRB submission and a summary of the changes. A template can be found in the . ☐ Not FDA Related Documentation Yes No N/A Notes Reviewed This section is applicable only to studies conducted under an investigator-held IND, IDE, or BLA. Did the PI submit the necessary ☐ ☐ ☐ ☐ regulatory application(s) (e.g. IND)? Are all IND/IDE submissions and supporting materials (if applicable) ☐ ☐ ☐ ☐ available? TIP: It is highly recommended to include a Submission Summary Table with each IND, IDE or BLA. Was the FDA properly notified of ☐ ☐ ☐ ☐ amendments and new information? Have Safety Reports been reviewed ☐ ☐ ☐ ☐ and reported as appropriate? Have all annual reports been ☐ ☐ ☐ ☐ submitted in a timely manner? Is FDA correspondence (including confirmation letters, ☐ ☐ ☐ ☐ acknowledgement letters, and reports) on file? Is a list of studies for which the PI Note: The list is only applicable in is/was responsible available and up preparation for an external ☐ ☐ ☐ ☐ to date (should include title, start and stop dates)?
Is an IRB member roster present and up to date? ☐ ☐ ☐ ☐ Is an FWA present and up to date? ☐ ☐ ☐ ☐ Has a final protocol closure report been submitted to regulatory authorities and filed appropriately (if applicable)? ☐ ☐ ☐ ☐ Informed Consent/HIPAA Authorization Forms Yes No N/A ☐ Not Reviewed Notes Are all versions of the IRB approved informed consent/assent present and filed? ☐ ☐ ☐ ☐ Are all versions of the IRB approved HIPAA Authorization(s) present and filed? ☐ ☐ ☐ ☐ Are all versions of the IRB approved information sheets present and filed (if applicable)? ☐ ☐ ☐ ☐ TIP: Tracking/version history logs are often used to track informed consent versions approved with corresponding IRB submission and a summary of the changes. A template can be found in the . FDA Related Documentation Yes No N/A ☐ Not Reviewed Notes This section is applicable only to studies conducted under an investigator-held IND, IDE, or BLA. Did the PI submit the necessary regulatory application(s) (e.g. IND)? ☐ ☐ ☐ ☐ Are all IND/IDE submissions and supporting materials (if applicable) available? ☐ ☐ ☐ ☐ TIP: It is highly recommended to include a Submission Summary Table with each IND, IDE or BLA. Was the FDA properly notified of amendments and new information? ☐ ☐ ☐ ☐ Have Safety Reports been reviewed and reported as appropriate? ☐ ☐ ☐ ☐ Have all annual reports been submitted in a timely manner? ☐ ☐ ☐ ☐ Is FDA correspondence (including confirmation letters, acknowledgement letters, and reports) on file? ☐ ☐ ☐ ☐ Is a list of studies for which the PI is/was responsible available and up to date (should include title, start and stop dates)? ☐ ☐ ☐ ☐ Note: The list is only applicable in preparation for an external
Self-AuditToolRegulatoryFileReview-2016_11_11_clean.docx