Page 256 - CHST Research Administration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration Department SOP No: R102 SOP Title: Creating Study Logs
monitor visit log in order to confirm that the accuracy of monitoring reports and regulatory accountability, are confirmed, completed, and properly documented in the essential study files in the regulatory binder.
Where there is no mandatory outline of the monitor visit log, it is important to list the protocol title, protocol number, site name/number, PI name, and sponsor name in the header of each page. Also, the page number in the sequence of pages included in the DOA is typically seen in the footer. Additionally, the visit date, reason for visit, sponsor representative name printed, sponsor representative signature, site representative name printed, and site representative signature are displayed as columns in the monitor visit log and each visit entered as a new entry in the rows of the log. Please, see the example below for reference.
MONITOR VISIT LOG
Protocol Title:
Protocol No:
Site Name:
Sponsor:
Principal Investigator:
Visit Date(s)
Reason for Visit (SEV, SIV, RMV, etc.)
Sponsor Representative
Printed Name
Sponsor Representative
Signature
Site Representative
Printed Name
Site Representative Signature
Footer: Page X of X
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