Protocol Deviations

The CDASHIG DV domain is intended to collect protocol deviations or violations that occur after enrollment. It is not intended to collect information about inclusion/exclusion criteria; that data should be collected in the IE domain.

Considerations Regarding Use of a Protocol Deviations CRF

Sponsors must employ a robust and systematic method for recording protocol deviations; this may include the use of a dedicated CRF for this purpose, or the intentional inclusion of data collection fields throughout the entire set of CRFs that will detect protocol deviations.

The DV domain metadata and example CRF were developed as a guide that sponsors could use for designing a DV CRF and associated database, should they choose to do so.

A CDASH CRF for Protocol Deviations was not included as part of this effort. The eCRF Portal team decided to purposely exclude this CRF as part of the package, as protocol deviation capture is so specific to each company and technology. The team wanted to allow for users to decide the format that is best for their situation. If you decide to capture Protocol Deviations in an EDC system, whether it is Site documented or CRA documented, please create your CRF using the Protocol Deviation domain and standard CDASH nomenclature using the CDASHIG as a guide.