The Good Clinical Practice (GCP) guideline is the international Ethics and Scientific Quality standard for conducting clinical trials

RMH has adopted the GCP guideline for all clinical research

RMH Requirements

  • All members of RMH research teams must hold a current, valid GCP training certificate - this includes Principal Investigators, Associate Investigators, Research Nurses and Research Coordinators/Managers.
  • The GCP training course must meet the minimum criteria set out by TransCelerate Biopharma Inc. and appear on their website.
  • Face to face (live) GCP training should be undertaken (this may be remotely delivered).
  • Online training is acceptable in the short term and only for a period of 12 months from the training date. For overseas based on-line training, research staff should also read the online training supplement for Australian specific content.

What GCP training does the RMH provide?

  1. GCP Training for Staff with no prior GCP training
  • Staff that have not undertaken GCP training previously are required to undertake a standard GCP training course (not a refresher course that assumes prior knowledge).
  • Sessions organised by the RMH are currently remotely delivered, live and interactive.
  1. Refresher training -
  • Refresher GCP training courses are acceptable for for updating training for staff that have previously completed a GCP training course (live or online).
  • RMH provides a refresher training course for staff that have previously completed a GCP training course. The sessions are currently remotely delivered, live and interactive.

Recognition of GCP Certification

GCP certification is valid for three years unless the certification period stated on the GCP certificate states otherwise.

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

Online training is acceptable in the short term and only for a period of 12 months from the training date.

RMH GCP training schedule

Remote delivery via Zoom of live interactive sessions

Session TypeDate & TimeBooking information
GCP training for staff with no prior trainingTuesday 13 September 2022
4:00-6:00 PM
Register here
Refresher GCP trainingWednesday 19 October
4:00-5:30 PM
Register here
GCP training for staff with no prior trainingTuesday 9 November 2022
4:00-6:00 PM
Register here
Refresher GCP trainingWednesday 29 November
4:00-5:30 PM
Register here

Fees

The following fees and conditions apply to face-to-face (may be delivered remotely) training provided by the Office for Research.

Attendee typeFee (ex. GST)*
Royal Melbourne Hospital employeeNo fee
Students$89
External person (i.e. non-RMH employee)$189

* Note: Fees incur GST and a service fee from Eventbrite; and Fees may change without notice

Cancellation conditions

For RMH employees

  • Cancellation of the booking will not attract a fee if notification is received at least 24 hours prior the session
  • Bookings may be transferred to another session if request to transfer is received at least 24 hours prior to commencement of the session.
  • Non-attendance will incur a $50 fee unless the booking was cancelled, or request to transfer was received, at least 24 hours prior to commencement of the session.

For external persons and students:

  • Cancelled bookings will not receive a refund
  • Bookings may be transferred to another session if request to transfer is received at least 2 days prior to commencement of the session at no extra cost.

Online GCP training courses

  • Online training is acceptable in the short term and only for a period of 12 months from the training date - also refer to the online training supplement .
  • The GCP course must meet the minimum criteria set out by TransCelerate Biopharma Inc. and appear on their website.
  • Several choices are available on the online training supplement, however the list is not exhaustive.
  • For overseas based on-line training, some information is incorrect or not applicable for Australian researchers. Refer to the information provided on page 2 of the online training supplement for a summary of the Australian updates.
  • The RMH Office for Research is not responsible for payment of fees incurred from external training, including online training.

GCP Frequently Asked Questions

What is the Good Clinical Practice (GCP) Guideline?

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.

Adoption of the GCP guideline - why do I have to comply with it?

Originally developed for pharmaceutical trials, the Good Clinical Practice (GCP) guideline has becoming widely adopted as the standard for all clinical research.

RMH has adopted the GCP guideline for all clinical research.

The Therapeutic Goods Administration (TGA)

  • The 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.

The National Clinical Trials Governance Framework

  • The Australian Commission on Safety and Quality in Health Care -The National Clinical Trials Governance Framework and user guide for health service organisations conducting clinical trials recommended that all trial investigators and their clinical trial site staff have an understanding of, and receive training in the Principles of GCP for the conduct of clinical trials
Who needs GCP training?

All RMH members of the researcher team must hold current, formal GCP certification training. This includes Principal Investigators, Associate Investigators, Research Nurses and Coordinators/Managers.

Note: The Australian Commission on Safety and Quality in Health Care -The National Clinical Trials Governance Framework and user guide for health service organisations conducting clinical trials recommended that all trial investigators and their clinical trial site staff have an understanding of, and receive training in the Principles of GCP for the conduct of clinical trials.

Does the requirement for GCP training apply only to researchers conducting clinical trials?

No; all members of RMH researcher team conducting clinical research at RMH must hold current, formal GCP certification training. This include the study principal investigator, associate investigators, research nurses and coordinators, data managers.

The clinical research may be Quality Assurance studies, retrospective audits, clinical research or clinical trials.

How can I access the GCP Guideline?

Click here to access the current GCP guideline (revision 2) from the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceutical for Human Use (ICH) website.

What type of GCP courses are available at Royal Melbourne Hospital?

Face-to-face (live) GCP training

The RMH Office for Research organises face-to-face (live) GCP training for RMH staff at no cost.

Face-to-face GCP training is mandatory for all RMH members of RMH research teams.

The RMH Office for Research is not responsible for payment of fees incurred where staff attend other training courses.

Online training - is not provided by the RMH

Online training is accessible from a wide number of providers.Several choices are available on the online training supplement .

Persons that complete an oline training course should also read the online training supplement .

The RMH Office for Research is not responsible for payment of fees incurred where staff attend other training courses, including online training.


How do I access GCP training?

Via the RMH Office for Research

  • Book into a training session using the links on this page; or

Other courses*

RMH research staff are also able to access face-to-face GCP training from external training providers. The RMH Office for Research is not responsible for payment of fees incurred from external training.

Researchers are reminded to ensure that any GCP training completed meets RMH requirements:

  • Training is face-to-face; and
  • Meets the minimum criteria set out by TransCelerate Biopharma Inc; and
  • The training provider appears on the list of courses on TransCelerate Biopharma Inc. web page.
What GCP training is acceptable?

RMH 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.

What do I do with my GCP certificate?

Principal Investigators (PI) are required to provide evidence that all RMH researchers and staff involved in the conduct of a research study at RMH are appropriately qualified, including 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 PI and/or 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 certificates for all RMH researcher team members should be included in the study research governance application submitted to the Office for Research.

How long does GCP certification last?

Face to face training (including remotely delivered live courses)

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

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

Online training

Online training is only recognised for a period of 12 months of the training date.

Research staff that complete online training are required to complete face-to-face GCP training within 12 months of the training date.

Online training is accessible from a wide number of providers. When accessing online training ensure that the course meets minimum Mutual Acceptance requirements of Transcelerate Biopharma INC.

Also refer to the online training supplement .

GCP training should be refreshed at least every three years in order to remain up to date with current regulations and guidelines (Australian Commission on Safety and Quality in Health Care -The National Clinical Trials Governance Framework and user guide for health service organisations conducting clinical trials)
What happens when my GCP certification expires?

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

Related links