A clean handoff is less about moving files and more about transferring meaning. Programming teams need an agreed view of source structure, standards versions, derivation logic, metadata and downstream reporting expectations.
Questions to resolve
- 01
Freeze the expected SDTM inputs and document known limitations
- 02
Agree ADaM dataset purpose, population flags and key analysis variables
- 03
Link derivations to protocol objectives, SAP decisions and output shells
- 04
Track cross-dataset dependencies and controlled terminology decisions
- 05
Define acceptance checks, review evidence and issue ownership
Applicable standards and versions depend on the study start date, sponsor plan and current regulatory expectations.