Page 354 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Rec-003 SOP Title: Secured Shared Drive
• 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).
Serious Adverse Events/Unanticipated Problems:
This section should include Instructions how to report adverse events and serious
adverse events.
Protocol Deviations:
This section should include copies of:
• Protocol deviation form or memo.
• Requirements for reporting protocol deviations are specific to each local IRB;
review the requirements to make sure that they are followed appropriately. Clinical Site Monitoring Visits:
This section should include copies of:
• A site visit log signed by the clinical site monitor(s) at each visit
• Visit reports
• Visit correspondence, such as a confirmation or follow-up letter.
Refer to Appendix B: Page 10 for sample. Sponsor Correspondence:
This section should include:
• Records of correspondence with the sponsor, including approval of initial study documents, approval of protocol amendments, and approval to initiate the study.
• Correspondence may be kept in a separate binder. In this case, note to file should be included in the appropriate section of the regulatory binder referencing where these documents are stored.
Data Safety and Monitoring Documents: This section should include copies of:
• The Data Safety and Monitoring Plan (if not included as part of the study protocol)
• Study reports generated for the independent safety monitor(s)
• Minutes from the independent safety monitor(s) meeting(s)
• Recommendations and correspondence from the independent safety
monitor(s). Other:
This section should include:
Other important study documents, such as certificates of confidentiality, literature or publications, etc.
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