NMPA Issues Guideline on Management and Archiving of Required Documentation for Drug Clinical Trials

The National Medical Products Administration (NMPA)  of China has released a circular as a guiding principle for the preservation of essential documents for Drug Clinical Trials. The Guideline has been formulated and issued effective from 01 July 2020 onwards.

The aim of the guideline is to secure necessary documents for drug clinical trials which is referring to the documents for evaluating the implementation of clinical trials and the quality of data. The preservation of documents will ensure that researchers, sponsors, and inspectors have complied with “Test Quality Management Standards” and relevant laws and regulations of drug clinical trials.

NMPA has tabulated the mandatory document, purpose, investigator or clinical trial organization, and sponsor.
Among the documents required are such as The Investigator’s Handbook where the investigator certifies that the sponsor has provided them with the latest scientific research results and possible damage to the human body related to the trial drug to the investigator. Others include a signed clinical trial plan (including revised version), sample case report form, the information provided to the subject (sample), the financial contract of the clinical trial, relevant documents of the subject’s insurance (if any), and more.

The guideline also lists the documents for the phases of the clinical trials conducted and after the clinical trials have been completed.

The necessary documentation for drug clinical trials provides evidence authenticity of trials and integrity of the collected data. The process is an important aspect of the regulatory inspection.

More information can be obtained from :-http://www.nmpa.gov.cn/WS04/CL2138/378032.html