About Good Clinical Practice (GCP)

GCP is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provided by International Conference of Harmonisation (ICH) GCP. Compliance with the GCP standard provides public assurance that the rights, safety and wellbeing of trial subjects are protected and that the clinical trial data are credible.

GCP is set of rules and regulations provided by International Conference of Harmonisation (ICH). All study staff involved in clinical trial is recommended to be refresh and update their knowledge of GCP at least every two years. GCP refresher reinforces the importance of concepts covered in the basic level of GCP for clinical trials.

When I took my GCP for the first time, I felt I was lost and unsure how a clinical trial is conducted. With this GCP Refresher, I’m able to grasp more information and I strongly encourage those with GCP certification to attend this refresher course.

Dr. Rozita ZakariaFMS, Klinik Kesihatan Sultan Ismail, Johor

I took my GCP 9 years ago, and I stop doing research for while. Through this GCP refresher course, I found that it’s important to look back at the guidelines and at the same time gain experience from fellow investigators.

Dr. Mohd Fauzi AdbullahFMS, Klinik Kesihatan Kuah, Kedah

The GCP certification itself is challenging for me, but for this refresher course I find it very interesting and I gain more understanding through the training videos. I’ll encourage my fellow clinicians to attend this course.

Dr. Rohayah IsmailFMS, Klinik Kesihatan Sentul, Kuala Lumpur

This is a good course to attend as it changes my views compared with my first time attending GCP course previously. The tips and encouragement given motivates me to persue more clinical trials.

Dr. Teoh See WeeFMS, Klinik Kesihatan Segamat, Johor

Why GCP Refresher?

The main objectives of the training are:

  • To provide a revision of GCP for study team.
  • To improve skills and knowledge on managing the conduct of clinical trial.
  • To share recommendation and lessons learnt with investigators on how to ensure GCP compliant.

Who Should Attend?

This GCP Refresher course are customised training for anyone who has previously completed GCP training that is approved by National Committee for Clinical Research (NCCR) and/or anyone who with GCP certified. This one day GCP Refresher training is dedicated to enhance competence of the investigators and research team.

Upcoming Workshop

Course Outline

The training begins with the completion of the GCP pre-assessment which contains of 20 Multiple Choice Question (MCQ) questions. The participants were also required to complete the GCP post assessment at the end of the training. The objective of this assessment is to determine the difference from GCP knowledge between pre- and post-assessment. Participant who completes the training will be awarded with certificate.

This GCP refresher training will refresh participant’s knowledge on:

  1. Introduction of GCP
  2. Investigator
  3. Sponsor
  4. IRB/IEC
  5. Protocol Deviations
  6. Informed Consent
  7. Safety management

Enquiry?

If you have any questions related to our GCP Refresher Workshop, send your message below

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