Pharmews

Guideline on the Submission of Clinical Trial Data (Draft for Public Review) Center for Drug Evaluation, NMPA May, 2020 Table of Contents 1. Background and Purposes 3 2. Submission Components of Clinical Trial Data 4 2.1 Study database 4 2.2 Analysis database 5 2.3 Data Definition File 6 2.4 Annotated CRF 7 2.5 Programming Code 7 3. Submission Document Format and Conventions 8 3.1 Portable document format 8 3.2 Extensible mark-up language format 8 3.3 Plain text format 8 3.4 Data transport file format 8 3.5 Dataset split 9 3.6 Dataset name, variable name and length 9 3.7 Dataset labels and variable labels 10 4. Other Considerations 10 4.1 Traceability of trial data 10 4.2 Data files under eCTD 11 4.3 Foreign language database 11 4.4 Communication with regulatory agency 11 References 11 Guideline on the Submission of Clinical Trial Data 1. Background and Purposes Clinical trial data is one of the important mate