How to identify lack of sponsor oversight?

The sponsor should ensure that all trial-related tasks, which are outsourced to the contract research organisation (CRO)/vendor, are carried out in accordance with the protocol, written agreements, GCP and local requirements. Especially, when the trial tasks are outsourced to different CROs/vendors at the same time, it’s challenging to ensure oversight.

What is adequate sponsor oversight? How can lack of sponsor oversight be identified? These are some difficult questions. Based on the recent inspection findings, PharmaGCP has some thoughts about the topic, which we would like to share with you. Your comment is very welcome.

Here are some issues indicating lack of sponsor oversight:

• Co-monitoring visits were not performed in accordance with the monitoring oversight plan and were not reviewed as required.
• Inadequate documentation to demonstrate when monitoring visit reports created by CROs were reviewed, by whom and the outcome of the review.
• Inadequate documentation to demonstrate the review of protocol deviations.
• No communication plan describing how to escalate issues to the sponsor in timely manner.
• Errors and non-compliance occurred at site which were not detected through monitoring and of which the sponsor was not aware.
• Late reporting of SUSARs to the Ethics Committee by the CRO.
• Late reporting of SAEs by the investigators.
• Trial Master File was not maintained at on-going basis.
• Oversight activities were described in the CRO plan, but there was no evidence demonstrating compliance with the oversight activities plan.

The list can be longer and you are welcome to comment on this in the comment field below. Thank you.

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