Page 195 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration Department SOP No: R-Reg-103 SOP Title: Creating Study Logs
Please, see the departmental Note to File documenting that lab personnel are not represented on the delegation of authority (DOA) log as they do not meet the criteria for being considered study team personnel and as such do not complete sponsor specific training (see attachment).
DELEGATION OF AUTHORITY LOG
Protocol Title:
Protocol No:
Site Name:
Sponsor:
Principal Investigator:
Printed Name
Signature
Initials
Start Date
End Date
Role
Responsibi lity Code(s)
PI Initials/Date
1. Administer Informed Consent
2. Obtain Medical History
3. Conduct Physical Exams
4. Obtain Vital Signs
5. Review I/E Criteria
6. Drug Dispensing /
Accountability
7. Obtain ECGs
8. AE/SAE Assessment
9. Phlebotomy
10. Lab sample processing
11. Review labs/ECGs
12. Determine eligibility
13. CRF Completion
14. Source Documentation
15. Query Resolution
16. Screening
17. Investigator Binder
Maintenance
18. IRB Correspondence
19. Study Management
20. Other: _______
End of Log page: COV - PI’s printed name, signature and date Footer: Page X of X
5.4 Monitor Visit Log: This log is important for tracking instances when the monitor has visited the study site to oversee the conduct of the study. Monitors are responsible for visiting the sites at planned and routine increments in order to evaluate the site feasibility (i.e., Site Evaluation Visit), to train and active the site (i.e., Site Initiation Visit), to monitor the conduct and quality of the study and the data obtained throughout the duration of the study, and to close the site once the study has been completed, closed or terminated.
The FDA and GCP provide outlines for appropriate study monitoring. It is both the study coordinator’s and the sponsor’s responsibility for documenting each monitor visit. Also, the sponsor and regulatory agencies can refer to the
Page 6 of 8