1. Scope of application: This guideline applies to clinical trials conducted for medical device registration, including the ones conducted overseas.
2. Basic principles: (1) Truth; (2) Traceability; (3) Readability:
3. Related information and description of clinical trial data
Materials related to clinical trial data of medical devices usually include original databases, analytical databases, explanatory documents, and programming codes.
- (1) The original database usually contains original data collected directly from case report forms and external documents.
- (2) The analysis database is a database formed for statistics and analysis the original data conveniently. It is used to generate the statistical results in the clinical trial report (including baseline, efficacy and safety indicators, etc.).
- (3) The codes mainly include the code for generating the analysis database from the original database, and the codes for generating the statistical analysis results from the analysis database, etc.
- (4) Explanatory documents
- • Data explanatory documents: It is used to describe the content and structure of the original database and the analysis database, which helps the reviewer to quickly understand the data sets, variables, and their structural relationships in the database, and to accurately understand the submitted data content.
- • The explanatory documents of programing codes: It is used to explain the used method, system, and software environment of the programing code file, including whether to modify the program code when using the code file and how to modify the programming code.
- • Annotated case report form (CRF): It reflects the correspondence between variables in the database and CRF information collection.
- • Other explanatory documents
4. Submission format
The original database, analytical database, descriptive documents, and code shall be placed in four folders separately.
It is recommended that the original database and analysis database be submitted in the XPT data transmission format (XPT V5 or higher version).
The explanatory documents can be in PDF, Word, Excel and other file formats, among which the variable dictionary is recommended to be an Excel file, and the annotated CRF is recommended to be a PDF file.
The programming code is recommended to use the TXT file format.