Along with a slew of clinical evaluation and clinical related guidelines updates (drafts) in support of the State Order 739, this clinical Trial Data Submission Guideline further clarified the requirement for data integrity in clinical trial. In the past year or so, more and more hospitals are asking requiring 3rd party audit before they close the study. Please contribute your feedback to this guideline. If you need help in providing this feedback, please email me.
NMPA issued the Guideline for Medical Device Clinical Trial Data Submission Requirements (draft) on September 15, 2021, for feedback. The feedback needs to be submitted by October 10.
Significantly referring to the Clinical Data Interchange Standards Consortium (CDISC) standards, the draft guideline details requirements on the original database, analysis database, explanatory documents, and program codes.
When providing Chinese translations for foreign materials, please note that for the original and analytical data sets, at least descriptive texts in variable labels and observations (such as descriptions of adverse events) should be translated.
Basic Principles
When submitting clinical trial data, the three principles of "true", "traceable" and "easy to read" should be followed.
- "True" means that the data should be consistent with that recorded in the Case Report Form, CRF. During the data entry process, data should not be changed without authorization. If there were abnormal values or clerical errors in the CRF table or the original record, the researcher should be notified in the form of a record (such as the query procedure), and the data can be updated only after the original record has been signed and confirmed by the researcher.
- "Traceability" means that the statistical results in the analysis database and clinical trial report can be reproduced from the original database according to the data and codes submitted by the registration applicant.
- "Easy to read" means that reviewer is familiar with the data variables and their structural relationships, and it's easy to retest of statistical analysis.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------