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 email@example.com.
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 firstname.lastname@example.org 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.
|Wednesday 19 September|
12.00 pm - 1.00 pm
|Drafting study agreements||Closed|
|Monday 15 October|
1.00 pm - 2.00 pm
|Tentative topic - Launch of the new guidelines for Data Management in Research and supporting SOPs and forms||Book here|
Tuesday 13 November
|Important Research updates - What you need to know for 2019||Book here|
|Monday 10 December|
10.00 am - 11.00 am
|Budgets for all study types (from big $ to no money at all)||Book here|
Missed a session?
If you missed a session, click on a CSG session topic below to review the slides:
- August 2018 – Requirements and processes for iPM and ECM medical records
- September 2018 – Drafting study agreements
- October 2018 – Data Protection by design
REDCap Support Group – monthly sessions
REDCap is a secure web application for building and managing online surveys and databases. Using REDCap at MH means that the data is stored on the MH server. These sessions are aimed to support Melbourne Health users of the database and are run by the Office for Research in conjunction with the Business Intelligence Unit. The sessions will provide a basic overview of how to get started using REDCap and provide a platform for you to ask questions and obtain answers to any problems you may be having.
MH staff can request a login for the REDCap data account at https://BIREDCap.mh.org.au/signup.
Refer to the Office for Research MH REDCap FAQ sheet for further information about the system and getting started.
|Monday 3 December, 10.00 am - 11.00 am||Book here|
Good clinical practice (GCP) is the international standard for conducting clinical research. MH has implemented the requirement that ALL members of the Melbourne Health research team, 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 Face to Face GCP training sessions - for MH staff only
|Wednesday 5 September, 8.00 am - 12.00 pm||Closed|
Tuesday 16 October, 12.00 pm - 3.00 pm
|Monday 12 November, 9.00 am - 12.00 pm||Session Full|
|Thursday 6 December, 8.00 am - 12.00 pm||Book here|
Face to Face GCP Training
From 1 July 2019, face to face GCP training will be mandatory. Face to face sessions provide interactive and stimulating learning where researchers can ask questions relevant to their studies and experiences, challenge information and receive instant feedback.
Face to face GCP training is provided by MH onsite and free of charge for MH staff. Typically face to face GCP training sessions are approximately 4 hours in duration.
This initiative means that if your current GCP training is via an online module, you will need to book in and complete face to face training before 1 July 2019. It is MH's preference for research staff to maintain current face to face GCP training, renewed every three years, with online training used only in the instance where there are time pressures and only with prior approval from Research Governance Manager.
Quick reference information to complement GCP
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 Melbourne Health 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 Melbourne Health or shared with any third party.
- The documents are an aid and do not replace any regulatory documents or Melbourne Health 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 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.