Page 234 - CHST Research Administration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No: R101 SOP Title: Regulatory Binder
• Documentation of study product (e.g., botanicals, probiotics, or other natural products disposition and accountability, or memo as to where records are located (e.g., research pharmacy) and who is maintaining accountability logs.
• For blinded clinical studies, it is recommended that study product accountability records be filed in the research pharmacy to maintain the blind. A note to file should be included in the appropriate section of the regulatory binder explaining how these documents are stored and maintained at the pharmacy with the pharmacy contact information.
Refer to Appendix B: Page 6 for sample.
Local Clinical Lab Certificates/Reference Ranges:
For studies that use clinical laboratories for specimen testing, this section should include:
Lab reference ranges if the reference range is not included on the lab form
• A copy of certifications or accreditations (College of American Pathologists [CAP], Clinical Laboratory Improvement Amendments [CLIA], or state certificate) or a memo indicating the laboratory maintains CLIA certification.
• A copy of the Lab Approval letter (see attachment)
• A copy of the Lab Director’s CV and License
• 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. Refer to Appendix B: Page 9 for sample.
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:
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