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Hello,
I’m requesting opinions related to filing Clinical Study Reports in an eTMF system. My company prepares CSRs in an authoring system that is separate from our eTMF. Our CSRs include a stand-alone synopsis section, a report body, and multiple individual appendices (one of which contains the wet-ink signatures). Some CSRs are submitted immediately upon signoff; some are submitted at a later date. The components of a CSR that are submitted to reg authorities is determined by the requirements of the particular country, therefore one CSR submission may have different components than another. I would appreciate hearing how folks file their CSRs in an electronic TMF system. For example, following CSR signoff, do you file all the CSR components (including all appendices) in 02.03.01 at study level? Do you then also file the applicable CSR components in 03.03.02 at country level once a submission has occurred, or do you only file the submission cover letter that indicates the CSR components that were submitted to the agency? Thank you. -
There are a few points to consider here:
* In the US, CSRs are generally submitted in the granular format using the study tagging file. As a result, a monolithic report may not exist, but the granular format is not very digestible for users of the eTMF (nor for transfer back to the sites, which I believe is a requirement). I know several of my clients took time to produce a somewhat condensed single file report that was then filed in eTMF.
* some CSR appendices (protocol, sample CRF) already exist in eTMF. It would probably be confusing to re-file these.
* other items listed as appendices (investigator curricula vitae, ethics committee approvals, informed consent forms, and batch numbers per subject) are in the TMF or clinical supply database and should generally not be included in the CSR appendices.So I think either a condensed CSR or the body, synopsis and certain selected appendices would be filed. (interestingly, the synopsis is actually smack dab in the middle of the report even thought it is a separate component in the STF). If you didn’t file the CSR but only a cover letter, then you would have to explain how people that need access to the actual CSR would get it (they may not have access to the submission system).
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