Design of case report form for oncology clinical trials based on CDASH / 中国临床药理学与治疗学

ABSTRACT

AIM: To investigate the design significance, method and content of the oncology clinical trial case report form (CRF) based on the clinical data acquisition standards harmonization (CDASH). METHODS: Compared with CDASH v 2.2, the characteristics of oncology clinical trial data were analyzed, and a standardized CRF was designed to meet the actual needs of oncology clinical trials. RESULTS: The CDASH was applied to the design of the CRF of the oncology clinical trial, and the data collection of the oncology clinical trial was standardized, so that the CRF design of the oncology clinical trial was relatively standardized and the data quality was improved. CONCLUSION: The implementation of oncology CRF design based on CDASH can promote the exchange and sharing of oncology clinical research data, which is conducive to improving the reliability of oncology clinical research results.