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
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