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.
Good clinical practice (GCP) is the international standard for conducting clinical research
GCP training requirements for RMH staff
The Royal Melbourne Hospital (RMH) has implemented the requirement that all members of RMH research teams, including Principal Investigators, Associate Investigators, Research Nurses and Research Coordinators/Managers, conducting research at RMH hold current, formal GCP certification training.
The GCP training must meet the minimum criteria set out by TransCelerate Biopharma Inc. and appears on the list of courses located on the TransCelerate Biopharma Inc. website.
Important information regarding GCP training due to COVID-19
In line with RMH's response to the COVID-19 situation, including the requirement to implement social distancing measures to the greatest extent possible, the following changes to the GCP training requirements and session have been implemented for RMH staff until further notice:
- Face-to-face training: Sessions will be delivered via interactive webinar only until further notice;
- Online training
- Online training may be completed when a staff member is required to complete GCP training before the next available face-to-face GCP training session.
- Online training completed in 2020-2021 will be recognised for a period of one year. RMH staff who undertake the online training will be required to complete a face-to-face GCP training session within 12 months of the date of the certificate.
Note: Online training for courses must meet the minimum criteria set out by TransCelerate Biopharma Inc. and appear on the list of courses located on the TransCelerate Biopharma Inc. website.
For updates on how COVID-19 impacts research at RMH visit the Office for Research COVID-19 webpage.
Face-to-face GCP training schedule
|Session Type||Date||Booking information|
GCP Training for new RMH researchers
Thursday 7 October 2021, 4:00-6:00 pm
Refresher GCP Training
Tuesday 16 November 2021, 4:00-5:30 pm
The following fees and conditions apply to face-to-face training provided by the Office for Research.
|Attendee type||Fee (ex. GST)*|
|Royal Melbourne Hospital employee||No fee|
|External person (i.e. non-RMH employee)||$189|
* Note: Fees incur GST and a service fee from Eventbrite; and Fees may change without notice
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 canceled, or request to transfer was received, at least 24 hours prior to commencement of the session.
For external persons and students:
- Canceled 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.
- For the remainder of 2020 research staff may complete of online GCP training in place of face-to-face GCP training.
- Online GCP training courses must still meet the minimum criteria set out by TransCelerate Biopharma Inc. and appear on the list of courses located on the TransCelerate Biopharma Inc. website.
- On completion of online training courses you will need to print out the certificate of completion for your files and forward a copy to the Office for Research.
- Email Krystal.Kemerer@mh.org.au to arrange access to online GCP training managed through the Office for Research.
- Online training will be recognised for a period of one year.
- Research staff who undertake the online training will be required to complete a face-to-face GCP training session within 12 months of the date of the certificate
- Only University of Melbourne MDRP students undertaking activities at RMH may complete an online GCP training managed by the Office for Research;
- The RMH student supervisor, or the student (with cc to RMH student supervisor), should contact the Office for Research by email to firstname.lastname@example.org to request online training. Please include confirmation that the MDRP student is undertaking activities at RMH, the host department and provide the students RMH email address.
- There is no cost for online training.
Alternative online GCP training courses
- Staff may complete any online GCP training for courses that meet the minimum criteria set out by TransCelerate Biopharma Inc. and appears on the list of courses located on the TransCelerate Biopharma Inc. website. Several choices are available on the online training supplement .
- 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.
Quick reference information
IQVIA (formally Quintiles) have provided handy information cards to assist researchers and research coordinators in management of their studies. These cards have been provided by IQVIA to the RMH because we are IQVIA's prime site in Australia. Reading these cards is for information only and does not constitute GCP certified training.
- ALCOA Principal - Elements of quality source documents
- Clinical study documents - Amendment implementation
- Electronic data capture - Best practices for sites
- ICH GCP E6 R2 What does it mean for sites - External information sheet
- Note to file
- Ongoing informed consent checklist
- Principal investigator oversight
- Preventing out of window visit deviations
- Safety reporting
- Site audits checklist
- Site audit and inspection readiness
- SOP guidance
- Source documentation guide for investigators
- Investigator's guide to management of investigational product
- These cards are IQVIA’s proprietary information and should not be removed from the RMH or shared with any third party.
- The documents are an aid and do not replace any regulatory documents or RMH SOPs.
- These materials do not constitute legal advice.
If you have any questions regarding the content of these cards, please contact your IQVIA study Monitor or the Office for Research at email@example.com.
GCP Frequently Asked Questions
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 RMH researchers conducting clinical research at RMH must hold current, formal GCP certification training. This includes Principal Investigators, Associate Investigators, Research Nurses and Coordinators/Managers.
No; all members of RMH researcher teams 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.
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.
Face-to-face and online GCP training courses are available.
Face-to-face GCP training is mandatory for all RMH members of RMH research teams.
RMH-run training sessions and online training is available via the Office for Research.
Face-to-face training is provided on site at RMH and is the preferred training method as the sessions are interactive and researchers can ask questions that are applicable to their research study.
Research staff that complete online training may be asked to complete face-to-face GCP training prior to the expiry of their current GCP certificate.
RMH also has access to an online training program which is available only to RMH employees and University of Melbourne MDRP students undertaking activities at RMH.
See "Online Training" section on this web page for instructions on how to request access.
Via the RMH Office for Research
- Book into a training session using the links on this page; or
- For online training and queries, email Krystal.Kemerer@mh.org.au.
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.
Resarchers 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.
MH 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.
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:
- File the GCP certificate in your training record;
- Provide a copy of the GCP certificate to the PI and/or coordinator for each clinical research project that you are involved in; and
- 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.
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, 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.
Temporary extension of approval periods due to impact of Covid-19
RMH will extend the approval period of current face-to-face or online training that expires in 2020/2021 for one (1) year. For example a GCP training certificate attained on 5 April 2018 would normally expire by 5 April 2021, but the approval period is currently extended to 5 April 2022.
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.