10. Who should review the oversight and monitoring strategy documentation?

The review of the documentation should be undertaken by appropriately qualified individuals within the sponsor organisation. Where there are several documents prepared by different areas, it is recommended that there is a cross-functional review to ensure consistency and compliance with the overall risk–based strategy.

There is no requirement to send additional documentation outlining the oversight and monitoring strategy to the MHRA or the REC as part of the approval process, as there is no requirement for this to be approved by the MHRA or REC, and there are currently no plans for this to be introduced in the future. The protocol musta, however, according to the principles of GCP that mustb be adhered to, contain the monitoring policy though this may not contain the level of detail that other sponsor documentation (plans/SOPs etc.) contains.

a. SI 2004/1031 (as amended) Schedule 1, Part 2 (7)
b. SI 2004/1031 (as amended) Regulation 28 (1) and (2)

Version 1: 22 February 2013