FOI release

Trial Documentation Inspection Findings concerning completeness, site personnel

Some or all of the information requested was not provided because we determined that the cost to do so would exceed the appropriate limit.

Case reference FOI2026/00059

Received 21 January 2026

Published 4 March 2026

Request

I would like to have access to any inspection findings concerning clinical trial documentation which concern: - Completeness: missing or incomplete documentation - Quality: miscataloguing of documentation - Timeliness: delays in capturing trial documentation - Site Personnel: any findings concerning documentation related to personnel involved in the planning and execution of the trial - Monitoring Visits: any findings related to the planning and execution of monitoring visits and their related documentation

Response

See attached

Documents

• FOI2026_00059 (redacted).pdf (872.7 KB)

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