Evaluation of Good Clinical Practice for Drug Trials Conducted According to Which Procedure?

According to the regulations in Circular 29, the process for evaluating compliance with Good Clinical Practice (GCP) includes 05 steps. To be specific:

- Step 1. The evaluation team announces the Decision to establish the evaluation team; the objectives, content, and evaluation plan at the clinical trial site;- Step 2. The clinical trial site presents a summary of its organization, personnel, implementation activities, application of GCP, or other issues as per the evaluation content;- Step 3. The evaluation team conducts a practical evaluation of the implementation and application of GCP at the clinical trial site according to each specific evaluation content;- Step 4. The evaluation team meets with the clinical trial site to inform about the level of GCP compliance of the clinical trial site, the unfulfilled contents that need rectification and corrections identified during the evaluation process; discusses with the clinical trial site in case the site does not agree with the evaluation team's assessment of each content.- Step 5. Prepare and sign the evaluation report. Note: The evaluation report must be signed by the Leader of the clinical trial site and the Head of the evaluation team. The report is made in 03 copies: 01 copy is kept at the clinical trial site, 02 copies are kept at the Filing Agency.

See the evaluation report regulations at Circular 29/2018/TT-BYT effective from January 01, 2019.

- Thanh Lam -

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