The NCI/CTEP is transitioning the existing NRDS initiative to the CDISC Implementation initiative to meet the the FDA mandate of submitting clinical study data sets in the SDTM format. Although the FDA does not require data to be collected in a certain format, the NCI is working in collaboration with CDISC to collect data in the CDASH format for the Oncology Patient Enrollment Network System (OPEN), Clinical Therapy Evaluation Program Adverse Event Reporting System (CTEP-AERS) and the Clinical Data Update System (CDUS). According to the FDA Study Data Conformance Guide, section 4.1.2 (SDTM General Considerations), it is recommended that sponsors implement the SDTM standard for representation of the clinical trial tabulation data prior to the conduct of the study. The use of case report forms that incorporate SDTM standard data elements such as CDASH allows for a more simplified process for the creation of the SDTM domain.
The CDISC Initiative will be implemented in a phased approach. Note these phases can run in parallel.
- Phase 1: Content collected in OPEN and the AE Forms within the SAE Integration
- Phase 2: Content collected in CDUS and the SAE Forms within the SAE Integration
- Phase 3: Oncology standards and LPO specific content
- Phase 4: NCI standards
The CDISC Implementation is a collaborative between with the NCI and the National Clinical Trials Network (NCTN) and Experimental Therapeutics Clinical Trials Network (ETCTN) to support all groups moving towards CDISC compliance.
