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Multiple acrfs for one study
SergiyHi Paulina, Data packages…
Hi Paulina,
Data packages for FDA submissions are driven by your Clinical Study Reports (CSR) in submission eCTD structure. In Module 3 (or 2 for non-clinical) you have folders [study] for study documentation such as CSR, Protocol, SAP, etc. In Module 5 (or 4) /datasets/[study], you need to have a folder with the same study name [study]. In regulatory submission, study data support study reports.
Therefore, in general if you have a single CSR for your study, then you need to create one SDTM/ADaM data package with combined aCRFs. If you have several CSRs and several folders in Module 3 for the same study, then you need to have separate data packages for each of them.
Be aware that this is just a common approach. You need to communicate with your Regulatory team and FDA reviewers assigned to your submission to confirm your plan or discuss their own preferences. Study Data Standardization plan is a good tool for such communications.
Kind Regards,
Sergiy
Hi, I have a question regarding multiple acrfs for one study (three-part study with two CRFs). What is the correct approach? Should two SDTM packages be created, or can there be only one with acrfs merge to one pdf for submission? Is it important whether the data has been collected into one or two initial databases? Thanks a lot in advance!