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Should a Sponsor create folders on his own company’s server in accordance with TMF RM in order to file there electronically the docs collected, which concerns need to be taken into account?
Should same Sponsor delegate the task to a CRO asking the CRO to act in the same manner as described above, so at the end of the study the CRO is requested to transfer the files from his local drive to the Sponsor, which concerns need to be taken into account in such case?
Many thanks.
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The MHRA have stated in their GCP Guide that this approach is unlikely to meet the applicable regulatory requirements. For example, no audit trails and limited security features. I’d advise reviewing carefully all requirements pertaining to the TMF and checking those against the functionality provided by network file storage.
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