10-CBA
Delegation of Responsibility & Staff Signature Log
CIBMTR CENTER # CENTER NAME PI Name:
Designee Full Name(printed) / Title
(PI, Sub-I, coordinator, data manager, etc.) / Designee Initials / Designee Signature / Delegated Activities
(see codes below) / Effective Date / End Date / # of years clinical research experience / Completion date of
Human Subjects Protection training
Study Activity Codes:
1. Medical History/ Physical Exam (Patient Care)
2. Drug Dispensing/Accountability
3. Query Resolution / 4. Recruiting/screening
5. Consenting/enrollment
6. Data collection (direct subject contact)
7. Adverse Event Assessment (Physician only) / 8. Study form Completion (including unscheduled forms)
9. Maintaining study files
10. Other-specify
Investigator’s Authorization: As Principal Investigator for the above mentioned investigational trial, I authorize the above staff to assume the indicated responsibilities. I understand that this in no way alters my responsibilities as defined in the Code of Federal Regulations, Title 21 CFR Part 50, 56 and 312.
Investigator’s Signature: Date: ______
In the case of log revisions, please re-sign and date:
Investigator’s Signature: Date: ______
Investigator’s Signature: Date: ______
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