Facilitated by Cinzia Piccini, Eli Lilly & Co
According to ICH E6, direct access should be granted to regulatory inspectors to examine, analyze, verify and reproduce any records and reports that are important to evaluation of a clinical trial. What are the considerations and challenges to grant such access in the Sponsor’s systems (e.g. eTMF, EDC, eCRF, ePRO, IVRS…)? Are there different approaches according to the type of systems (on-line/off-line), locations of the inspection (site vs. sponsor vs CRO)? What should sponsor expect from regulatory inspectors (e.g. being trained, hardware/software configurations etc.). Participants are encouraged to share their ideas and experiences!!
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