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).
- This reply was modified 9 months, 1 week ago by Kathie Clark.