Clinical Trial Governance
- What is clinical trial governance?
- What does the Clinical Trial Governance Office do?
- What is a site-specific assessment (SSA)?
- How do I submit my SSA?
- Risk Assessment
- Clinical Trial Notification (CTN) Changes Effective 1 July 2015
- Clinical trial agreements
- Starting a new trial to be sponsored by the University
- Online Applied Good Clinical Practice (GCP) Training for Researchers
- Site File Templates (Essential Documents) for Researchers
- Self-Audit Checklist
Clinical trial governance refers to the processes used by institutions to ensure that they are accountable for the research conducted at their sites. To be properly governed, research must be conducted according to established ethical principles, guidelines for responsible research conduct, relevant legislation and regulations and institutional policy. Clinical trial governance is also about credentialing and training of researchers and managing institutional risk. When assessing the risk, clinical trial governance is concerned with the quality, safety, privacy, risk management, financial management and ethical acceptability of the research.
Clinical Trial governance encompasses both the ethical review of research and the institutional considerations about undertaking research. Elements of research governance include:
- ethical approval
- compliance with legislation, regulations, guidelines and codes of practice
- legal matters, including contracts, and indemnity/insurance frameworks
- financial management, risk management and site-specific assessment
- institutional policies and procedures for responsible
research conduct and managing research misconduct
- management of collaborative research
- reporting requirements
The framework at the University of Sydney ensures clinical trial research conforms to relevant institutional and national standards, applicable laws and the Australian Code for the Responsible Conduct of Research.
Clinical Trial Governance provides guidance and support to researchers facilitating the University of Sydney’s obligation to the effective governance of clinical trials involving humans. The Clinical Trial Governance Office is responsible for assessing the suitability of a clinical trial to be conducted at a University of Sydney site and making a recommendation to the DVC-Research. The DVC-Research makes the final decision whether to authorise a clinical trial to be conducted at a University site.
Site-Specific Assessment is a key element of clinical trial governance, which involves the review of HREC approval, HREC approved documents, Site Specific Assessment (SSA) form, site specific documents, study budget, CTNs, Clinical Trial Research Agreements (CTRA), and insurance and indemnity arrangements (where applicable).
The University of Sydney undertakes a site-specific assessment (SSA) of each clinical trial being conducted at a university facility/site. This allows us to consider whether the project is suitable for the site, including whether we have capacity to conduct the clinical trial at that site. This SSA involves consideration of such matters as physical resources, staff, insurance and indemnity requirements and other matters.
You do not need to wait until you have approval from an ethics committee to start the SSA process - the SSA and HREC ethical and scientific review may occur in parallel. The final decision to authorise or not authorise the commencement of a clinical trial at the University of Sydney is only made when the responsible HREC has granted approval and the SSA has been satisfactorily completed. It is important to note that the SSA process is not part of the ethics application.
All SSA applications must be made on the Site Specific Application Form and submitted to the Clinical Trial Governance Manager at . A Site Specific Application (SSA) Checklist is also available to detail the documentation required for submission.
If you have submitted a SSA form to a hospital for the same study we are happy to accept that form updated for the University site.
Applications can be submitted at any time (there is no agenda closing date), however applications must be complete at the time of submission. If you are unsure of the requirements please contact the Clinical Trial Governance Office.
Clinical Trials must not commence at the University of Sydney until governance authorisation has been obtained.
Effective risk management is an integral and essential part of ensuring patient safety in clinical trials.
Risk management supports decision makers in understanding the benefits of conducting a clinical trial versus the risk and/or hazards associated with participant safety.
The University is required to maintain a risk management framework that aligns with the principles and practices of the Australian/New Zealand Risk Management Standard (AS/NZSIS0 31000:2009).
In support of the emerging transformation in how clinical trials are managed, US FDA released the “Guidance for Industry: Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring”(August 2013), and on its heels, the European Medicines Agency (EMA) issued the “Reflection Paper on Risk Based Quality Management in Clinical Trials” (November 2013).
Risk management concepts can be extracted from the ISO 14971: Risk Management for Medical Devices and ICH Q9: Quality Risk Management. The basic steps to risk management include: identify and assess risks, mitigate risks, and review risks. Additional steps that are required throughout the process include communication of risks and documentation of activities.
The Organisation for Economic Co-operation and Development (OECD) has published Recommendation on the Governance of Clinical Trials which promotes the use of a simple risk categorisation process to help investigators and sponsors develop proportionate systems for managing and monitoring their trials.
The Therapeutic Goods Administration (TGA) released an online CTN form on 1 July 2015. The form can only be submitted by clinical trial sponsors. At the University of Sydney all CTN Forms must be submitted by the Clinical Trial Governance Manager.
The paper-based notification form will no longer be available, as there are some differences in the required information for the new online form. Any paper based forms the TGA receives after 1 July will also need to be submitted online. If this impacts your clinical trial, please contact the Clinical Trial Governance Manager at .
If your clinical trial involves a medicine or device you will need to develop an agreement between the parties involved. This is true whether you are involved in a:
- collaborative clinical trial project,
- commercially sponsored trial,
- contract research organization trial, or
- trial funded from a grant.
You may also need to arrange for indemnity for the University, ethics committee or research premises. Standard templates for clinical trial agreements and indemnities have been developed and should be used wherever possible in order to minimise the need for legal review.
Templates for contracts and indemnities are maintained by:
- Medicines research: Medicines Australia
- Medical device research: Medical Technology Association of Australia
Clinical Trials insurance gives the University protection for legal liability to pay damages or compensation as a result of any claim or claims made by research subjects for bodily injury caused when participating in a clinical trial undertaken by the University. Each clinical trial sponsored by the University or completed within University facilities, should be listed on the policy. To ensure your clinical trial is listed on the University’s clinical trial insurance policy, Clinical Trial Governance requires the following information: protocol version & date, registration number, HREC approval, intervention, study start and stop dates, sample size and countries where the study will be completed.
If you are unsure if your clinical trial is listed on the University’s insurance, please contact the .
For staff considering conducting a clinical trial to be sponsored by the University, please contact Dr Vera Terry for assistance. A formal Risk Assessment will need to be arranged, and Dr Vera Terry will help you provide the required documentation. A site document template is available to provide Dr Vera Terry with the required legal information.
Please contact Dr Vera Terry for assistance via .
The following documents will be required by the Clinical Trial Governance Office when providing legal advice. Please email the following documentation to cc: .
- Participant consent form and information sheet
- Investigator’s brochure or approved product information for each drug/device (if relevant)
- List of responsibilities (if large multicentre study or international)
- Ethics approval / Governance approval
- Insurance certificates (if relevant)
- Letter from CI to appropriate Dean requesting approval for the study
- Other regulatory documents (as appropriate)
For more information on clinical trial governance, see the NHMRC Research Governance Handbook.
Clinical Trial Governance offers online training for researchers conducting clinical trials sponsored by the University and/or taking place at the University at no cost to researchers. The training provides an overview of Good Clinical Practice (GCP) in the following areas:
- Research and GCP Foundations (3 modules)
- Stakeholder roles and responsibilities (3 modules)
- Practical Considerations in the conduct of clinical trials (4 modules)
The training takes approximately 10 hours and, once registered, you are given two months to complete it. It can be stopped and resumed at any time and can be done at your own pace. On completion of the training, a Certificate of Completion will be issued, which is valid for three years.
For further information please email
NHMRC eLearning Modules
The NHMRC has released three eLearning modules available free of charge to the public. The learning objectives of the modules are to:
- understand how clinical trials take place is Australia
- understand and promote responsible research practices
- ensure quality research outcomes
- ensure participant safety is maintained at all times
Access the learning modules via the NHMRC eLearning Modules webpage.
Clinical Trial Governance offers assistance with setting up and maintaining your Investigator Site File (ISF). It is important to establish the Investigator’s Site File prior to the start of a clinical trial and it is the responsibility of the investigator to maintain and update information in the ISF throughout progress of the trial.
Site file templates are a useful resource for maintaining Essential Documents and used to evaluate the conduct and the quality of the clinical trial. We are providing researchers the following templates to assist in setting-up their ISF:
- Site File Guidance
- Site File Index
- Delegation Log
- Subject Identification Code List
Clinical Trial Governance (CTG) have developed a tool to assist researchers who want to monitor or audit their own clinical trials. The Self-Audit Checklist is designed to help researchers reflect on their research conduct; CTG are happy to assist with any issues raised by the process.
Monitoring can help to ensure that the trial is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirements.
For further information please email