Resources

For use when an organisation is receiving material/data.

For when an organisation is the owner/custodian of the material/data.

For when an organisation is the owner/custodian of the material/data.

Consider these best practices when negotiating an agreement.

The MIA is an NHMRC template agreement that details how the NHMRC funds will flow to the parties over the funding period.

In this template, the Collaborative Research Group is the sponsoring institution.

Workflow of site principal investigator serious breach responsibilities.

Reporting requirements, including frequency, report and responsibilities. 

Single-site, multi-site, or privately-funded the ethics application process differs for each type of clinical trial.

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:

• Record the type of consent obtained from each participant so that data sharing is in accordance with their permission
• Respect confidentiality of participants
• Collect and store research data and information using methodology that facilitates access, search and retrieval
• Use version control for data sets, standard operating procedures, study protocol and other essential documents
• Protect loss of data and information by using stable storage formats and storing electronic data or information on a system that has regular back up
• Use appropriate national and international standards for scientific terminology and information encoding

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:

• Anonymise the participant’s personal information as soon as practically possible
• Store the participant ID code separately from the CRF or database with restricted access
• Limit the collection of participant-identifying data to what is necessary to address the study aims
• Tag fields in the database containing participant-identifying data and restrict access
• Manage database user access throughout the trial so it is appropriate to the user role and that expired/suspended accounts are removed promptly

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.