Clinical Research and GCP Update

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CRITICAL sponsor findings – TMF SOPs

• The Standard Operating Procedures (SOPs) that were supposed to detail the eTMF best practices for quality management did not define the TMF and how it should contain all trial essential documents. It also did not define all the different systems that make up the TMF. • No clear policy and process to ensure the accurate completeness of the TMF contemporaneously.

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• Is it possible for a sponsor to issue a protocol waiver in response to an investigator seeking to modify trial entry criteria to make it easier to recruit trial participants?

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© Brookwood Global (Canary Ltd) 2021

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