Clinical trials – Data submission requirements for clinical trials of medical devices

Basic principles of clinical trial data submission: authenticity, traceability and readable

Material Submission

Material Content

Submission Requirements

Interpretation

Form of Submission

Raw Data Base

Case Report Form

Data sets and variables should be named in accordance with the principle of “readability”. It is recommended to refer to the English or pinyin of data sets or variables when naming them, so that the actual meaning of the name can be easily associated with the name

Interpretation:

①　There are no restrictions on the number and capitalization of the data set and a computerized optometer is added. For example, a computerized Optometer could be named COOP or DNYG.②　There is no mandatory requirement on identity variables and viewable variables, and there is no requirement on variable capitalization. You can freely name variables as long as they start with a letter.If the subject’s initials can be named SubIN or SSZXMSX, this also conforms to the “easy to read” principle.③ Suggestions for variable naming can refer to the unified standardized rules of drug clinical submission requirements.

XPT

（V5）

Raw data collected directly in external files

Analyzed Database

Variable data in the original database

The variable naming of the analysis dataset is the same as that of the original database.

XPT

（V5）

Data derived from the original database variable data in accordance with the methods previously determined in the clinical trial protocol and statistical analysis plan.

Information  Submission

Material Content

Submission Requirements

Interpretation

Form of Submission

Procedure Code

Code for generating analysis database from original database

The submitted code shall conform to the usual programming format and specification, with clear structure and easy reading. The program code shall include sufficient comments to describe the purpose of different program codes and other contents to be explained, so as to help reviewers better understand the code logic

If the submitted program code references the macro program, the corresponding macro program code shall be provided, and the software version and system environment for running the program shall be described.

①The submission of complex nested macro programs shall be avoided. If a complex nested macro program is submitted, it shall be fully verified to ensure that the program can be run in different computer system environments.

②Analysis and processing involving code are committed, support complex macros, and are executable.

TXT

Code that analyzes the database to generate statistical analysis results

Supporting paper

Data description file

It is recommended to use Excel files to list data sets, variables, variable types (such as character type and numerical type), labels, assignments and their corresponding relationships in the original database and the analysis database respectively in the form of tables

PDF

WordExcel，and so on

Instructions for the use of program code

Listing the program code files and data set file names used to generate each statistical result chart one by one in the form of a table.

The applicant for registration should state the encoding used for both the original data set and the analytical data set (e.g. UTF-8, EUC-CN, etc.) to avoid garbled data sets submitted.

Some redundant data unrelated to the analysis of clinical trial results may be collected in CRF. These data may not be included in the submitted database, but should be clearly marked as “not submitted” on the comment CRF, and the reasons should be clarified.

Other illustrative documents

In addition to the above illustrative documents, applicants for registration are encouraged to submit other illustrative documents (e.g., overview documents, other descriptions of special circumstances, etc.) that will help reviewers quickly understand the content and structure of the clinical trial database.