GCP Refresher Workshop

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 a set of rules and regulations provided by the International Conference of Harmonisation (ICH). All study staff involved in a 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.

Why GCP Refresher?

The main objectives of the training are:

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

Who Should Attend?

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

Workshop Outline

The training begins with the completion of the GCP pre-assessment which contains 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 between pre- and post-assessment. The participant who completes the training will be awarded a certificate.

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

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