Relevant guidelines to provide researchers with a launching pad for conducting their research. Developed in partnership with the Melbourne Academic Centre for Health (MACH).
This template is appropriate for clinical trials where the intervention is not a medicine, biologic or device. For example this may be a behavioural intervention or an educational intervention.The template is annotated with instructions that explain the information that should be contained in each section.
The template may have sections added or removed as relevant for the trial.
This protocol template is appropriate for clinical trials of medicine, biologic or device interventions. The template includes instructions to users that explain the information that should be contained in each section.
The template may have sections added or removed as relevant for the trial.
Data generated during a trial should be shared after the end of the trial. This may be through publication, as individual participant data or in a Clinical Study Report, for regulatory submissions.
Key questions that the Sponsor-Investigator needs to address in the planning stage of a clinical trial.
Time should be taken to develop the research question, determine participant eligibility criteria, understand any risks to participant safety and quality of the data, determine what data is required to answer the research question, obtain sponsorship approval and prepare and submit the ethics application.
A summary of key activities that occur during the conduct of a clinical trial.
This infographic highlights the activities that occur while the study is recruiting participants and collecting data. Activities include consent, data management, risk management, safety monitoring and safety reporting.
The role and function of the trial Biostatistician at each stage of the clinical trial life cycle from planning the trial through to sharing the results in publications and conferences.
The data generated during a trial should be shared through publication, as individual participant data and in a Clinical Study Report, for regulatory submissions.
This graphic describes storage and security requirements for research data and confidential information associated with research studies.
It is applicable to all study team members, including the Principal Investigator, Associate Investigators (AI), research coordinators, and data managers.
This infographic is a useful tool to assist Investigators to identify risks applicable to most clinical trials.
Ten categories of risk are provided with examples of individual risks that would require a risk management and/or monitoring plan.
This infographic highlights the minimum responsibilities of both the Sponsor-Investigator and any potential collaborator with a data sharing request. This includes maintaining security and confidentiality of the data and complying with data sharing policies and procedures of the institutional sponsor.
The Sponsor-Investigator is responsible for following their institution’s data sharing policy and the responsibilities of the collaborator should be outlined in a data transfer agreement.
This infographic highlights the best practice approach that researchers should use to facilitate data sharing after their trial has finished. This approach includes:
There are many varied approaches to monitoring trial conduct. Depending on the type of trial, and the resources available you can choose one or more of the styles. Each style has features to improve the effectiveness and quality of the way you’re managing your trial and collecting data.
Researchers should take steps to reduce the identification of participants throughout the trial. This includes:
Data validation checks should be performed on the data to check the data quality and data integrity. Checks may be undertaken manually or electronically (supported by the trial database) and include range, consistency, protocol and accuracy checks.
This infographic is a useful tool to assist Investigators to understand the data management processes that occur throughout the life cycle of a clinical trial.
Data management tasks begin during the protocol development phase and occur throughout all stages of the trial from clinical trial planning, through trial conduct/data verification/analysis, dissemination of results, and into the future with options for data sharing.
This approach provides a high-level overview of the processes an organisation can implement in order to provide a minimum level of assurance and adequate risk assessment for investigator-initiated trials.
The Principal Investigator applying for institutional sponsorship submits their application, including their draft protocol, to the institution’s Research Office. Depending on the institution, the application for sponsorship may be approved before the Investigator can submit an application for ethical and/or governance review, or alternatively, ethics review may occur in parallel with sponsorship review.
The Risk Impact Assessment Matrix can be used to assign an impact rating (low, medium, high) to individual risks identified for a trial.
The matrix uses the consequence of the risk (insignificant, minor, moderate, major, catastrophic) and the likelihood of it occurring, to assign the risk impact. Any risks considered to have medium or high impact should have a mitigation and management plan.
This approach uses a Sponsorship Committee to approve requests for institutional sponsorship of investigator-initiated trials. If the host institution/organisation conducts high risk trials, it may be appropriate that the institution’s sponsorship approval process include a sponsorship committee to provide an appropriate level of assurance and adequate risk assessment.
Committee members may include representatives from the grants team, legal department, and research governance office with options to include other experts as required according to the type of trial being submitted (based on level of risk, patient population, indication etc).
The sponsorship and ethics review process may occur in parallel or, ethics review may commence following sponsorship approval. Once sponsorship is approved, the Sponsor-Investigator will be required to inform the sponsorship committee of any change to the identified risks throughout the course of the trial.
The Sponsor-Investigator and clinical trial team, including co-investigators, study coordinators, research nurses, trial pharmacists and other supporting department staff, have responsibilities for the delivery of clinical trials that generate high-quality data in a safe environment.
It is useful to understand these responsibilities in terms of the four main stages of a clinical trial: planning and design, conduct, data analysis and dissemination of results.
Each stage has key activities that are summarised in this infographic, a useful tool to assist researchers to understand key activities and major milestones that occur during the clinical trial life cycle from clinical trial planning through to sharing results after trial completion.
Describes a risk-based approach organisations may use to determine if they are willing to sponsor an investigator-initiated trial. Successful applications will be issued with a Certificate of Sponsorship (signed by a representative of the committee and the Sponsor-Investigator) that outlines the tasks that the sponsoring institution has delegated to the Sponsor-Investigator as a condition of sponsorship.
In this example, a committee reviews each application for sponsorship, the application occurs in parallel with the ethics application review by the ethics committee.
Note: The Certificate of Sponsorship form that supports this SOP
This form is for use by the Principal Investigator when seeking institutional sponsorship by their institution. It is to be used in conjunction with the Institutional Sponsorship Application and Approval for Sponsor-Investigator Initiated Trials SOP.
The Principal Investigator is required to complete the form and associated risk management plan that is pre-populated with ten risk categories applicable to most trials. The table requires the Principal Investigator to enter the following information for each risk identified within the ten categories: consequence, likelihood, mitigation strategy, risk monitoring plan.
The form is then submitted with the latest draft of the protocol to the sponsorship committee for consideration. Further details about the sponsorship review and approval process are found in the SOP Institutional Sponsorship Application and Approval for Sponsor-Investigator Initiated Trials
Guidance to assist the Sponsor-Investigator or delegate to conduct a risk assessment for their trial and develop a plan to manage the risks from trial design through to reporting results.
An annotated Risk Assessment and Management Plan template is included with instructions for completion and examples of risks, mitigation and monitoring strategies.
Describes an approach that institutions may take to review an Investigator’s application for sponsorship. The document includes the process to be taken by both the Investigator and the research office and a checklist of items (areas of risk) that the Investigator must complete and submit to the research office.
A meeting is then scheduled with the Investigator and research office. Any issues raised must be addressed before the sponsorship request is approved. In this example, sponsorship approval is required before an application can be submitted for ethics approval.
This SOP describes the process for developing and implementing a Data Sharing and Access Plan (DSAP) for sharing data with external parties.
Includes template forms for a Data Share or Access Plan, Application to Share or Access Data and a DSAP internal review process.
This process map clearly shows the Sponsor-Investigator’s responsibilities for managing participant safety during a trial.
The process includes the different types of safety events and monitoring reports, the stakeholders involved and the timelines for completing all tasks.
A supporting document for the Institutional Sponsorship of Investigator-Initiated Trials SOP.
The certificate functions as evidence of sponsorship by the host institution. It also serves as the terms and conditions of sponsorship agreed by the Sponsor-Investigator, including the delegation of specific Sponsor responsibilities to the Sponsor-Investigator.