GCP Training

Good clinical practice (GCP) is the international standard for conducting clinical research and provides a framework for ensuring participants rights safety and well-being are protected and the data generated is credible. The GCP guideline details the requirements for stakeholder responsibilities, participant consent, documentation, protocols and amendments, requirements such as indemnity, reporting lines for adverse events and provision of medical care for trial participants. Originally developed for pharmaceutical trials, this guidance has become known as the "Good Clinical Practice" (GCP) guideline has becoming widely adopted as the standard for all clinical research.

The Therapeutic Goods Administration (TGA) has also adopted the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceutical for Human Use (ICH) GCP guidelines in Australia. The TGA has provided advice on the guideline relevant to the Australian context on the TGA website.

All Investigators and study coordinators conducting research at WH must hold current, formal GCP certification training.

No, ALL WH Investigators and study coordinators conducting clinical research at WH must hold current, formal GCP certification training. The clinical research may be Quality Assurance studies, retrospective audits, clinical research or clinical trials.

The current ICH-GCP guideline (can be downloaded on the right side link, from the TGA website.

Face to face training sessions will be available via the Office for Research in 2019. Please contact the Research Program Director, Mr Bill Karanatsios regarding upcoming dates for GCP training [email protected].

Face to face training is provided on site at WH and is the preferred training method as the sessions are interactive and researchers can ask questions that are applicable to their research study.

Alternatively, you can source any one of the many courses available through a training provider.

Important note: Remember to ensure that any GCP training you complete meets the minimum criteria set out by TransCelerate Biopharma Inc. and appears on the list of courses on TransCelerate Biopharma Inc. for the list of training providers (link below this page).

WH has adopted the minimum standards defined by TransCelerate Biopharma Inc. to recognise GCP training courses that contain material meeting the minimum criteria agreed to by its member organisations. Acceptable GCP training courses are those listed on TransCelerate Biopharma Inc website (link below this page).

Investigators and research personnel are required to provide evidence that they are holding current GCP certification. Therefore, you should:

1. File the GCP certificate in your training record;
2. Provide a copy of the GCP certificate to the coordinator for each clinical research project that you are involved in; and
3. Forward a copy of the GCP certificate to the Office for Research.

GCP certification is valid for three years unless the certification period stated on the GCP certificate is less than 3 years.

• For instance, if the certificate does not specify an expiry date, WH recognises GCP certification for three years.
• If the certificate states a two-year expiry date, then GCP training will be required after two years.

If you are still involved in research at WH, then you will need to update your GCP training by completing another GCP training course, this may be a refresher course.