Before implementing anEDC system upgrade, thefirst taskof the Data Manager is toassess the impact on the data.

According to theGCDMP (Chapter: Electronic Data Capture Systems)andFDA 21 CFR Part 11, any system upgrade must undergoimpact assessmentto determine how the change might affectdata integrity, functionality, validation, and ongoing study operations. This assessment ensures that no data are lost, corrupted, or rendered inconsistent during or after the upgrade.

The Data Manager should evaluate:

Potential effects on existing data, edit checks, and reports,

System functionality impacting current workflows, and

Any revalidation requirements.

Only after the impact is understood should the Data Manager proceed to communicate with sites (option A), update documentation (option B), or modify CRFs if required (option D).

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Electronic Data Capture Systems, Section 7.3 – System Upgrades and Change Control

FDA 21 CFR Part 11 – Change Control and Validation Requirements

ICH E6 (R2) Good Clinical Practice, Section 5.5.3 – Change Impact on Data Integrity and System Validation