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Guideline on the Submission of Clinical Trial Data in China (2020.5 Draft for Public Review)

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 Purposes3
2. Submission Components of Clinical Trial Data4
2.1 Study database4
2.2 Analysis database5
2.3 Data Definition File6
2.4 Annotated CRF7
2.5 Programming Code7
3. Submission Document Format and Conventions8
3.1 Portable document format8
3.2 Extensible mark-up language format8
3.3 Plain text format8
3.4 Data transport file format8
3.5 Dataset split9
3.6 Dataset name, variable name and length9
3.7 Dataset labels and variable labels10
4. Other Considerations10
4.1 Traceability of trial data10
4.2 Data files under eCTD11
4.3 Foreign language database11
4.4 Communication with regulatory agency11
References11




Guideline on the Submission of Clinical Trial Data
1. Background and Purposes

Clinical trial data is one of the important materials submitted by sponsor to regulatory agencies. It is a valuable resource for both regulatory ag…