Study Self Audit Tool
Regulatory Binder – Drug/Device/Biologic Good Clinical Practice (GCP) Studies
Date: ______/______/______Completed By: ______
RSRB#/Protocol# _____Study Title: ______Investigator: ______
Yes
/ No / N/A /Comments
IND/IDE/1572 /Is the FDA 1572 present, if applicable? /
Is the FDA 1571 present, if applicable? /
Is a Financial Disclosure Form present for applicable study team members? /
Is an Investigator’s Brochure/Package Insert/Device Manual present, if applicable? /
Is a copy of the IND/IDE FDA application present, if applicable? /
Is the IND/IDE FDA safe-to-proceed letter present, if applicable? /
Is the IND/IDE annual report present, if applicable? /
Are the IND/IDE application amendments present, if applicable? /
Are the IND/IDE safety reports present, if applicable? /
Are all FDA correspondence and associated documents present, if applicable? /
GCP Documents /
Are CVsof the Investigator, Co-I, and Sub-I(s) present? /
Are licenses of the Investigator, Co-I, and Sub-I(s) present (good documentation only)? /
If conducting studies containing lab samples (i.e. blood specimens), are lab certifications, licenses, and normal lab range values present? /
Is a Staff Signature Log present and complete? /
Is a Delegation of Authority Log present and complete? /
Is a Staff Training Log present and complete? (good documentation practice only) /
Is a Comprehensive Subject Log (including all subjects screened, screen-failed, withdrawals, and enrolled) present/complete? /
Is a Subject Identification Code list present/complete? /
Is a Randomization Log present/complete, if applicable? /
Is a Drug/Device Accountability and Dispensing Log present/complete? /
Is a Temperature Log present/complete, if applicable? /
Is a Sample of the Investigational Product label present? /
Are Point of Care monthly QI testing results on file, if applicable? /
Is a Conflict of Interest Management Plan on file? (if applicable; does not need to be in the regulatory file) /
*If any of these items, are keep electronically, place a Note to File in the regulatory binder indicating where it is stored.*
COMMENTS:______
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