(a) Reports of monitoring activities should include a summary of what was reviewed, a description of significant findings, conclusions and actions required to resolve them and follow-up on their resolution including those not resolved in previous reports. The requirements of monitoring reports (including their content and frequency) should be described in the sponsor’s procedures.
(b) Reports of investigator site and/or centralised monitoring should be provided to the appropriate sponsor staff as described in the sponsor’s procedures in a timely manner for review and follow-up.
(c) When needed, the report should describe findings requiring escalation for action and resolution. The sponsor should decide on the appropriate action to be taken, and these decisions and the resolution of the actions involved, where needed, should be recorded.