Delegation of Authority Log
Protocol Title:
Primary Investigator:
Site Number:
Sponsor Name or Ethics ID Number:
The purpose of this form is to: (a) serve as the site signature log and (b) ensure that the individuals performing study-related tasks and procedures are appropriately trained and authorized by the
principal investigator to perform them. This form should be completed prior to the initiation of any study-related tasks and procedures. The original form should be maintained at your site in the
regulatory/study binder. This form should be updated during the course of the study as needed.
Print Name
Study
Role
Study-Specific
Tasks
Signature
Initials
Start date of
Responsibilities
(DDMMMYYYY)
End date of
Responsibilities
(DDMMMYYYY)
PI Approval (PI
initials & date)
Note: Staff should only be delegated to tasks after they have completed any required training for that task.
Study-Specific Tasks: Customize for Study
7. Make study-related medical decisions
14. Randomize Subjects
21. Other (specify):
1. Obtain informed consent
8. Conduct diagnostic interviews
15. Enter data into EDC
_______________
2. Subject prescreening/recruitment
9. Dispense study drug
16. Perform fMRI
3. Confirm eligibility
10. Perform drug accountability
17. Maintain essential documents
4. Obtain medical history
11. Conduct C-SSRS Interview
18. Regulatory submissions
5. Perform physical exam
12. Collect Samples
19. Project Management
6. Administer/Read Urine Drug Screen & pregnancy 13. Sample processing and/or shipment
20. Other (specify): ______________________
test
I certify that the above individuals are appropriately trained, have read the protocol and pertinent sections of 21 Code of Federal Regulations Parts 50 and 56 (21 CFR Parts 50,
56) and the International Conference on Harmonisation and Good Clinical Practice (ICH GCP) Guidance, and are authorized to perform the above study related tasks and
procedures. Although I have delegated significant trial-related duties, as the principal investigator, I still maintain full responsibility for this trial
PI Signature at Study Close-out to confirm accuracy of log: _____________________________________________
Delegation of Authority Log Template Version 1.0 March 2020
Date: ________________
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