Amendments handled without stalling programming
Changes are scoped and specified quickly enough that ongoing dataset QC and interim programming keep moving on the current specification version.
What's included
Keeping specifications synchronized with the protocol and SAP
- Change impact assessment against the SDTM mapping spec and ADaM spec for every protocol amendment or SAP revision
- Redlined specification updates with a version history that ties each change back to its source amendment
- Downstream review of affected edit checks, derivations, and TLF programs before the next dataset refresh
- Sponsor and biostatistics sign-off captured before an updated specification is released to programming
- Version-controlled specification archive maintained for audit and inspection traceability
One team catches the ripple effects
Because the programmers writing the update sit alongside the biostatisticians who revised the SAP, downstream impacts on derivations and TLFs get caught at the source.