ABSTRACT
Migrating is the process of moving existing data into a new system. The new system in question may be an entirely new application, a signi—cant version upgrade to a clinical data management (CDM) system currently in production, or movement of clinical data from one electronic case report form (eCRF) version to another for electronic data capture (EDC) studies. Whenever data is migrated, companies should be prepared to provide proof that the migration did not adversely affect existing data in any way (through deletion, addition, or modi—cation) in order to comply with the explicit requirements of 21 CFR (Code of Federal Regulations) Part 11 and also the recommendations found in the Food and Drug Administration (FDA) comments that preface the rule. This veri—cation of the data may be very simple in the case of a version upgrade where the structures underlying the application (e.g., data management system) remain largely the same. The veri—cation, and in fact the whole process of migration, is much harder when moving data to a new system where the data being migrated is transferred or mapped to new structures and possibly even transformed somewhat in the process.
