Bulky Documents At Local Investigator Sites

Hi all

GCP states that the IB/ protocol etc must be located in the file of the institution (ISF) to document that the investigator has received this information.

Do other CTUs insist that entire IBs/ protocols must be filed, or would anyone consider it acceptable if only the front page/ signature pages of superseded documents were filed as evidence of receipt and agreement? We would insist that the full document was retained for the most recent version and we would obviously retain full versions in the TMF.

This policy would reduce costs for archiving at sites. Do any CTUs have experience or advice for this?

Thanks, Terry

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