The success of any clinical research study depends on highly trained study teams. Each study team should have effective and efficient processes and have a mind-set that is absolutely focused on protecting patients’ rights and assurance of data integrity as well as the day to day conduct of the study.
To achieve this, each member of the research team must be appropriately qualified and experienced for their role on the research study and must participate in ongoing training and education appropriate to their role.
The Office for Research supports the ongoing education and training of its researchers and study staff by providing a range of education and training options. We also encourage researchers to provide suggestions for potential education sessions that may be of benefit. Please email you suggestions to firstname.lastname@example.org.
Research email updates – to ensure you receive training and other research updates send your Melbourne Health (MH) email address along with your position description (i.e. PI, AI, research nurse) to email@example.com and include “Request to add researcher to research email list” in the subject line of the email.
Coordinator Support Group – monthly sessions
Research Coordinators and Managers are vital to the efficient and effective conduct of clinical research. The Office for Research is committed to helping you manage your research projects and find solutions to the problems that you encounter along the way. The support groups will provide a platform to share knowledge, ask for ideas/help, discuss problems, raise issues that collectively we may be able to find solutions to and share successes. The sessions are safe spaces to encourage open sharing of ideas and problem solving but will only be effective with input from you.
|Monday 27 August|
11.00 am - 12.00 pm
|Requirements and processes for iPM and scanning research documentation into the MH medical records ERM system - information and feedback session.||Book here|
|Wednesday 19 September|
12.00 pm - 1.00 pm
REDCap Support Group – monthly sessions
REDCap is a secure web application for building and managing online surveys and databases. REDCap at MH means that the data is stored on the MH server. These sessions are aimed to support users of the database at Melbourne Health who have queries or problems, not for training new users in the system.
The MH Business Intelligence Unit will be coordinating some more formal training sessions which twould be ideal for new users as a starting point. MH staff can request a login for the REDCap data account at https://BIREDCap.mh.org.au/signup.
|Friday 24 August, 1.00 pm - 2.00 pm||Book here|
|Wednesday 12 September, 1.00 pm - 2.00 pm||Book here|
|Monday 8 October, 10.00 am - 11.00 am||Booking not yet open|
|Tuesday 6 November, 12.00 pm - 1.00 pm||Bookings not yet open|
|Monday 3 December, 10.00 am - 11.00 am||Bookings not yet open|
Good clinical practice (GCP) is the international standard for conducting clinical research. MH has implemented the requirement that ALL MH researchers, including Principal Investigators, Associate Investigators, Research Nurses and Research Coordinators/Managers, conducting research at MH hold current, formal GCP certification training that meets the minimum criteria set out by TransCelerate Biopharma Inc. and appears on the list of courses located on the TransCelerate Biopharma Inc. website.
Upcoming GCP training sessions
|Wednesday 5 September, 8.00 am - 12.00 pm||Book here|
|Tuesday 16 October, 12.00 pm - 3.00 pm||Book here|
Other MH and precinct partner training and education links
- Melbourne Health Grand Rounds
- Victorian Comprehensive Cancer Centre Monday Lunch Live sessions
- The Doherty Institute Seminar Series
- Walter and Eliza Hall Institute of Medical Research
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 MH researchers conducting clinical research at MH must hold current, formal GCP certification training. This includes Principal Investigators, Associate Investigators, Research Nurses and Coordinators/Managers.
No, ALL MH researchers conducting clinical research at MH must hold current, formal GCP certification training. 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 training sessions and online training is available via the Office for Research.
Face to face training is provided on site at MH and is the preferred training method as the sessions are interactive and researchers can ask questions that are applicable to their research study.
Melbourne Health also has access to an online training program. 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.
Important note: 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.
MH researchers who do not hold current GCP certification should email the Manager Research Governance and Audit at firstname.lastname@example.org to arrange to undertake GCP training.
An MH training program is also available on this page (refer under GCP Training above)
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 MH researchers and staff involved in the conduct of a research study at MH 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 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, MH 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 clinical research at MH, then you will need to update your GCP training by completing another GCP training course, this may be a refresher course.