Standards for Investigators in Clinical Drug Trials

Nguyen Trinh

18:39, 11/07/2024

Recently, the Ministry of Health issued Circular 29/2018/TT-BYT stipulating regulations on clinical drug trials.

Individuals who are researchers in clinical drug trials must meet the following conditions and standards:

- Possess a degree or professional certificate issued or recognized in Vietnam, suitable for the job position;- Hold a valid practicing certificate appropriate for the assigned task;- Possess a valid GCP completion certificate issued by the Ministry of Health or a GCP training institution, updated every 3 years;- Possess a valid certificate of completion for a safety reporting course in clinical drug trials per GCP, issued by the Ministry of Health or a safety report training institution, updated every 3 years;- The research team must have a sufficient number of members, with the right composition for the assigned task, and have adequate time dedicated to the research.

More details can be found in Circular 29/2018/TT-BYT which takes effect on January 1, 2019.

>> CLICK HERE TO READ THIS ARTICLE IN VIETNAMESE

0 lượt xem

- This translation is generated by OpenAI's GPT-4o model;
- The legal regulations in this article are according to Vietnamese Law;
- This English translation is for reference purposes only and not a definitive translation of the original Vietnamese texts;
- Articles may be compiled from a variety of sources;
- Applicable Terms may have expired at the time you are reading;
- If you have any questions about the copyright of the article, please contact us via email [email protected]