Application of annotated case report form based on study data tabulation model in domestic clinical trials
TAN Lei
CHAO Jian-qian
Abstract：The data interchange standards created by the Clinical Data Interchange Standards Consortium(CDISC),which have been recognized and promoted by most countries,can greatly improve the data quality of clinical trials and the efficiency of reviewers.The US FDA and the Japan Pharmaceuticals and Medical Devices Agency have specified that clinical trials of new drugs must comply with CDISC standards.China National Medical Products Administration also encourages the application of the standards,but most of the raw data and annotated case report form(aCRF)submitted by local clinical trial sponsors do not meet the CDISC standards.They have various forms and non-standard structures,which greatly affect the review period of new drugs.This article introduces the concept and importance of the study data tabulation model(SDTM)aCRF,focuses on its production processes and requirements,and discusses the application of standardized aCRF in clinical trials of China,aiming to promote the standardization of clinical trial data in China.
Keywords：clinic trialdata submissionClinical Data Interchange Standards Consortium Standardsstudy data tabulation modelannotated case report form
Publication Date：2024-02-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：4( 270-273 )