Guidance on Assessing GCP Compliance of Clinical Trial Facilities

16:07, 11/07/2024

Recently, the Ministry of Health issued Circular 29/2018/TT-BYT amending and supplementing Circular 03/2012/TT-BYT regarding regulations on clinical drug trials.

The assessment of compliance with Good Clinical Practice (GCP) of clinical trial facilities is divided into 03 levels, specifically:

- Level 1: The clinical trial facility complies with GCP without any issues that need to be addressed or corrected.- Level 2: The clinical trial facility has issues that need to be addressed or corrected to comply with GCP; these issues do not affect the quality of the research and the safety and health of the participants.- Level 3: The clinical trial facility does not comply with GCP in the following cases:- There are discrepancies with GCP standards that could impact the quality of the research and/or the health and safety of the trial participants;- Fraud, falsification, or manipulation of data, records, or documentation.

For more related regulations, see Circular 29/2018/TT-BYT, effective from January 01, 2019.

- Thanh Lam -

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