Good Clinical Practice Malaysia

Ministry of health malaysia institute for clinical research block b4 national institutes of health nih no 1 jalan setia murni u13 52 seksyen u13 40170 shah alam selangor darul ehsan malaysia phone.

Good clinical practice malaysia. The 12 modules included in the course are based on ich gcp principles and the code of federal regulations cfr for clinical research trials in the u s. Malaysian guideline for good clinical practice 4th ed page 8 introduction to malaysian guidelines for gcp good clinical practice gcp is an international ethical and scientific quality standard for designing conducting recording and reporting clinical trials that involve the participation of human subjects. The drug control authority dca had endorsed guideline for good clinical practice inspection in accordance with the regulation 29 under control of drugs and cosmetics regulation 1984 in the 221 meeting on the 29th october 2009. Take up the quiz below and get to refresh your memory as you test your understanding.

The malaysian guidelines for good clinical practice. Have you just taken the gcp 101 course and feel ready for the upcoming exams. Clinical practice guidelines cpg can be access via. Gcp serves as the international standard for designing conducting monitoring documenting analyzing and reporting clinical trials.

Pharmacists at ministry of health malaysia moh who attended the workshop and passed. The production of the malaysian guidelines for good clinical practice gcp is indeed very timely and necessary in the wake of a greater demand by the pharmaceutical industry to conduct clinical trials in malaysia. Gcp certification is a mandatory requirement for researchers who want to participate in clinical trial. Good clinical practice gcp is an international standards concerning the ethical and scientific quality in designing implementing documenting and reporting of clinical trials involving human subjects.

It is of utmost importance. Laman sesawang kementerian kesihatan malaysia di http www moh gov my atau di klik pautan ini http www moh. The good clinical practice gcp course is designed to prepare research staff in the conduct of clinical trials with human participants. Good clinical practice gcp is a set of guidelines for clinical research done on human subjects.