Sponsors
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We are preparing for a sponsor audit. They have specified the studies they want to review. They have also, originally, requested demonstrations of the computer systems used. This has now changed to include a demonstration of a new EDC we’ve adopted that was not used for those studies.
We don’t think this is relevant. Certainly out of scope as it was not the data capture tool used and is irrelevant.
It seems more like they want to to see what we use for any future studies of their we may conduct to me but that is a vendor assessment and not auditable (SP!).
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