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January 3, 2020 at 2:44 pm #2769
My comments would be applicable to any document considered to be part of the TMF but kept outside the main eTMF/TMF.
- The documents must be included on the TMF Plan / TMF Index, together with the identification of the storage location/system
- The documents must be capable of being made readily available in the event of an inspection or audit; this includes being able to easily identify and retrieve relevant documents by study number, site number and/or PI name, as appropriate
- The documents must be accessible to relevant team members to confirm relevant quality standards and completeness requirements have been met
- The documents must be retained in accordance with GCP requirements, including transfer to an archive under the control of an archivist for the period of time required by pertinent regulations
- There must be a reasonable rationale for storing the documents in a system other than the main eTMF/TMF
For documents such as Master Service Agreements that cover multiple studies, sponsors who file these in the TMF usually have a level of filing above study level or file an electronic copy in each applicable TMF. I think there is likely to be a majority of sponsors who file MSA’s outside the TMF, in a contracts management system.
Hope this helps.