Helpful information and links for researchers at the Women's.
Good Clinical Practice training
The Good Clinical Practice (GCP) guideline is the international ethics and scientific quality standard for conducting clinical trials.
In accordance with the National Clinical Trials Governance Framework, clinical trial investigators and their clinical teams must have access to - and undertake training in - the principles of GCP.
The Royal Women’s Hospital has adopted the International Conference on Harmonisation (ICH) GCP guideline for all clinical research studies conducted at the Women's.
What are the Women's requirements?
- All members of the Women's research teams must hold a current, valid GCP training certificate before they commence working on a research project. This includes Principal Investigators, Associate Investigators, Research Nurses and Research Coordinators/Managers, pharmacists, and anyone undertaking a trial-specific procedure that is additional to standard care.
- A valid GCP training certificate must be uploaded via the SSA form in ERM for all staff before the start of a research study at the Women's.
- Researchers must forward copies of their certificates to the Research Office.
Good Clinical Practice Training
The GCP training course must meet the minimum criteria set out by TransCelerate Biopharma Inc. and appear on their website.
You can access a free online course provided by the Australian Clinical Trials Education Centre (A-CTEC). This course is free but does require you to have an account with A-CTEC.
This course is TransCelerate-recognised and tailored to the Australian regulatory environment.
Further action:
Set up an Australian Clinical Trials Education Centre account.
Enrol in Australian Clinical Trials Education Centre training.
Grants and funding
The Women’s is committed to improving the health and wellbeing of women and newborns through research and innovation.
Funding is vital in advancing research and its translation into clinical practice.
Research grants and funding support can be sourced via the Australian Government, Victorian Government, donations and bequests, philanthropic grants and research partners.
Links to grant funding opportunities can be found under ‘Research’ on the Women’s staff intranet.
Statistical support
You may have also have to source paid external statistical advice depending on the complexity of your needs.
See below for options for external statistical consultation:
Statistical Consulting Centre (The University of Melbourne)
Public Health and Preventative Medicine (Monash University)
Health Sciences Library
The Health Sciences Library is the staff library for the Royal Women’s Hospital, RMH, PMCC and Victorian Mental Health.
All staff employed by the Women's can use the library services and resources. To request support, contact the library.
Access to library resources is enabled for all hospital computers.
Offsite and personal device access is available with library membership.
- Journals and articles - across all medical, nursing and midwifery, and allied health topics
- Research support
- Training on how to search, database advice, reference management and related topics. Sessions can be individual or small group, online or in person.
- Advice and support for systematic and other literature reviews
- Covidence – a web-based tool that streamlines the systematic review workflow.
- Help guides on topics such as how to search the literature, critical appraisal, publishing information, starting a literature review and more.
- Evidence-based practice
- Request a literature search to find evidence on your topic.
- Request full text of articles.
- Books - wide range of eBooks on medical and nursing topics plus a small collection of print books held at the library at Royal Melbourne Hospital.
- Databases
- Health literature databases such as Medline, Embase, CINAHL.
- Medical and drug information databases.
- Study space – ground floor of RMH, Transit Lounge corridor. After-hours access available on request.
Research agreements
When are agreements required?
Where research involves more than one party or organisation, a research agreement assigning responsibilities to each of the partners must be signed before research commences. More than one agreement might be required.
When preparing research agreements, researchers should consider:
- How long the project is likely to take?
- How will intellectual property ownership and licences be assigned?
- What are the publication rights for each party and investigator?
- What are the financial considerations i.e. costs for HREC/governance review, overall project budge, funding source, payment terms, invoicing and cost centres?
- What are the reporting obligations?
- What are the contributions and deliverables of each party?
- What are the terms of termination for each party?
It is the responsibility of the project sponsor to initiate the agreement. A key point to consider when planning a research project is that there are standard research agreements available (more detail below). Contract negotiation, where legal review is required by various parties, can be slow and delay research. Standard research contracts have been developed to help streamline approvals and authorisation of research. If wording of the standard agreement is changed, or special conditions included the agreement will require legal review and will delay the execution of standard form agreements.
The Women’s recommends use of standard agreements, including those developed by Medicines Australia and Melbourne Academic Centre for Health (MACH).
For investigator-initiated studies or collaborative research group (CRG) studies, the coordinating principal investigator (or their delegate) from the lead site will oversee initiation, drafting and signing of agreements.
For commercially sponsored studies, the project sponsor will generally be the contract research organisation (CRO).
The agreement should be in writing and must cover intellectual property, confidentiality and copyright issues; sharing commercial returns, responsibility for ethics and safety clearances; and reporting to appropriate agencies. It should address the protocols to be followed by the partners when disseminating the research outcomes and the management of primary research materials and research data.
The inclusion of this information is needed to:
- Minimise risk of conflict and confusion
- Clearly state what payments are involved
- Detail data/information use and storage conditions
- Clarify ownership of intellectual property
An authorised representative from each of the partnering organisations must sign-off on the agreement to make it binding. For the Women’s, this will be a member of the executive – the Chief Medical Officer.
A research agreement:
- Sets out the binding terms governing the relationship between the parties.
- Sets out the rights and obligations of each party and is a tool that can be used if things go wrong.
- Protects the interests of the sponsoring institution
- Helps mitigate risks, limit liability and make sure adequate insurance is in place
- Protects the sponsoring institution’s assets and intellectual property
- Ensures the sponsoring institution complies with obligations to funders and other collaborators
- Protects the interests of the researchers involved
- Sets out expectations
- Protects them from being personally liable if things go wrong
- Protects their intellectual property rights, including publication rights and right to use the results for research purposes
- Protects the interests of participants or other individuals involved in the trial by setting out confidentiality obligations and making sure parties comply with relevant privacy laws.
Types of research agreements
A CTRA outlines the obligations and responsibilities of both the sponsoring institution and the participating site with regards to:
- Protocol, conditions of ethics approval, applicable standard operating procedures, regulatory and legislative requirements
- Conduct of the study
- Investigational product
- Payments
- Provision of equipment & software
- Confidentiality
- Privacy
- Liability and insurance
- Publications
- Study results and intellectual property
- Disputes
CTRA templates have been developed for sponsored clinical trials. Please note the sponsor listed on the agreement must be an Australian entity. Templates from the following organisations have been reviewed and are approved for use by the Women’s Legal Counsel:
Medicines Australia has five Clinical Trial Research Agreements (CTRAs) – download templates on the Medicines Australia website:
- Commercial sponsor: Standard Medicines Australia Clinical Trial Research Agreement (CTRA) for a commercially sponsored trial – to be used when a commercial entity (e.g. pharmaceutical company) is sponsoring a clinical trial
- Contract Research Organisation (CRO): Standard Medicines Australia Clinical Trial Research Agreement (CTRA) for Contract Research Organisations acting as the Local Sponsor – to be used when a CRO is sponsoring a clinical study on behalf of an international sponsor.
- Collaboration (or Cooperative) Research Group (CRG): Collaborative or Cooperative Research Group (CRG) Studies Clinical Trial Research Agreement (CTRA) – to be used when a non-commercial entity, such as a research group, is sponsoring a clinical trial
- Phase 4 commercial studies: Standard Phase 4 Clinical Trial CTRA – to be used for Phase 4 drug trials sponsored by a commercial entity
- Phase 4 CRO: Standard Phase 4 Clinical Trial Contract Research Organisation (CRO) acting as the Local Sponsor CTRA – to be used for Phase 4 drugs trials where a CRO assumes all of the responsibilities of a local commercial sponsor.
Clinical Investigation Research Agreements (CIRA) – for devices
The Medical Technology Association of Australia (MTAA) have developed Clinical Investigation Research Agreements (CIRA) for sponsored device clinical trials. An important distinction between CIRAs developed for the pharmaceutical and the medical technology industries is the use of the international standard ISO 14155 for the study of medical technology. The MTAA agreements reference this standard. These standard templates can be used if the sponsor is an Australian entity:
- The MTAA Standard Clinical Investigation Research Agreement (CIRA) – for use in a commercially sponsored trial or interventional study
- The MTAA CIRA: Standard Clinical Investigation Research Agreement Post Market – for use in a commercially sponsored trial or interventional study
- The MTAA CIRA: Contract Research Organisation acting as the Local Sponsor – for use in a commercially sponsored clinical trial or interventional study where CRO is acting as local sponsor
- The MTAA CIRA: Post Market Clinical Trial (Medical Devices) – Contract Research Organisation acting as Local Sponsor - for use in a commercially sponsored clinical trial or interventional study where CRO is acting as local sponsor
- The MTAA Standard Indemnity Form for a Clinical Investigation – standard indemnity for use in a commercially sponsored clinical trial or interventional study. Indemnity is the responsibility of the Women’s where it is an investigator initiated clinical trial or interventional study.
Download templates on the MTAA website
Melbourne Academic Centre for Health (MACH) has an agreement for non-interventional investigator initiated projects – download template on the MACH website.
Where two or more institutions/parties are involved in developing the trial protocol or sharing other Sponsor responsibilities, a RCA would be required.
The RCA would define the terms of the collaboration and the protocol must be inserted into Annexure A.
Download template: CTRA: Collaborative or Cooperative Research Group (CRG) Studies, Medicines Australia (Word)
A Service Level Agreement (SLA) outlines expectations and obligations between a service provider and the institution. Examples in the context of research may include external pathology providers, or external electronic data capture or data management providers.
Where an investigator-initiated trial receives support from a commercial company or other service, a service agreement will need to be completed before that support is provided. The service provider will usually have a template.
NHMRC grant-funded research that involves collaboration between two or more sites must have a NHMRC Multi-Institutional Agreement (MIA) in place. The MIA is an NHMRC template agreement that details how the NHMRC funds will flow to the parties over the funding period and include details on who the administering institution is, intellectual property ownership, publication rights, insurance and indemnity obligations etc.
More information: Funding agreement, NHMRC
Where material or data owned by the Women’s is to be sent to an external body that is not a participating trial site or the sponsoring institution, a Material Transfer Agreement (MTA) must be completed.
The Women’s has an MTA template. Email research.office@thewomens.org.au for a copy.
If an external party requests access to data collected as part of an investigator-initiated trial, a Data Transfer Agreement (DTA) will need to be executed by the individual/third party requesting access to the data and the sponsoring institution prior to the transfer of data.
The DTA sets out the obligations of the data requester in relation to storage and use of the data. It describes the terms and conditions which must be agreed to prior to the release of data, including obligations to:
- Only use the data for the purposes of the project described in the data access application.
- Comply with all applicable laws in relation to the use and storage of the data.
- Keep the data secure and not to further distribute it without the sponsoring institution's prior permission.
- To give the sponsor investigator the opportunity to contribute and potentially be named as author on publications if appropriate, and to acknowledge the sponsoring institution as the source of the data.
The sponsoring institution retains all ownership and intellectual property rights to the data. The data requester is granted a limited license to use the data for their specific project. The recipient is required to inform the sponsoring institution of any new intellectual property rights developed from use of the data, and the parties will then negotiate their respective ownership rights.
DTA templates covering the Women’s either as a recipient or provider of data are available. Email research.office@thewomens.org.au for a copy.
If confidential information will be shared with, or received from an external organisation, a Confidentiality Agreement (otherwise known as a confidential disclosure agreement (CDA) or non-disclosure agreement (NDA) will be required.
The agreement ensures that the external organisation/individual maintains the confidential nature of the information and only uses the information for the specified purpose.
Date reviewed: 24 January 2025
Date reviewed: 24 January 2025