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30th May 2018, 03:11 PM
#1
Essential Documents and Non-Selected Sites
During the site selection phase, there may be a small set of documentation generated for a site that is not selected. The documentation is typically artifacts such as Confidentiality Disclosure Agreements, letters regarding pre-qualifying visits, etc. The reason for non-selection is typically contained in summary documentation which is included in the TMF. Considering that these sites contributed nothing to study (no patient data, no HA/RA approvals, no IRB/IEC approvals, no IP receipt), would this small set of documentation be required for the TMF?
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