[John Parker]

Hi David

In my experience it will vary and I would take in to account the risks associated with the study in respect to the TMF and the knowledge and experience that is built up with the Phase I CRO if they have been delegated responsibility for managing the Sponsor TMF. There is no mandated frequency, only that the Sponsor will implement an appropriate level of QC to ensure the right level of quality is achieved.

[Author]

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