CRF version management
A case report form (CRF) is a document that captures and stores data in pharmaceutical and medical device clinical trials following the Title 21 CFR Part 11 guidelines.
Important
In eClinical, CRFs are designed and maintained in the Study Designer (SD) application and then populated to EDC for data entry. In EDC, you can only upgrade the CRF version for sites or subjects to keep the system up-to-date.
Each time there is a need to implement any changes to a CRF, a new version for it is created in SD and you can upgrade your sites, subjects, and study to the latest CRF version in EDC. Furthermore, keeping track of all the CRF versions throughout a trial is vital for compliance reasons.
In EDC, with the CRF Version functionality, you can perform versioning management during the study development as well as make post-production changes after a study goes live.
In this section, you can learn about the following features of EDC in terms of CRF versioning: