When an updated version of adata exchange standard(such as CDISC SDTM, ADaM, or ODM) is released, the first factor that should be assessed isbackwards compatibility. This determines whether the new version can interoperate with or accept data from prior versions without significant reconfiguration or data loss.

According to theGood Clinical Data Management Practices (GCDMP)andCDISC Implementation Guides, assessingbackwards compatibilityensures that historical or ongoing study data remain valid and usable within the updated environment. If the new version introduces structural or semantic changes (such as variable name modifications or controlled terminology updates), it could impact mapping, validation, or regulatory submissions.

Once backward compatibility is confirmed, secondary assessments such ascontent coverage,availability of overlapping standards, andmigration costcan be considered. However, ensuring that the new version supports existing infrastructure and data continuity is thefirst critical stepbefore adoption.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Standards and Data Integration, Section 4.2 – Data Standards Updates and Compatibility Considerations

CDISC SDTM Implementation Guide, Section 1.5 – Backward Compatibility and Version Control

ICH E6(R2) GCP, Section 5.5 – Data Handling and Standardization