We have protocol that is split into multiple parts/studies - we are debating if we should create SDTM/ADaM separate for each part or combine them - We expect it to be under one SAP, CSR. Are there any FDA requirements for these and any recommendation/expereince of one approach vs the other.
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Hi,
We have protocol that is split into multiple parts/studies - we are debating if we should create SDTM/ADaM separate for each part or combine them - We expect it to be under one SAP, CSR. Are there any FDA requirements for these and any recommendation/expereince of one approach vs the other.
Thanks
Deepika