Site Team

Sponsor

An individual, organisation, or group taking on responsibility for securing the arrangements to initiate, manage, and finance a research study or trial. In the case of externally Sponsored studies, that means the Sponsor is an individual, organisation, or group external to Melbourne Children’s.

Principal Investigator

The PI is the person responsible, individually or as a leader of the research study or trial team at a site, for the conduct of a research study or trial at that site.

The PI is responsible for conducting the research study or trial in accordance with the approved protocol, delegating study tasks and procedures as appropriate, ensuring adequate clinical cover is provided, ensuring compliance with the protocol, and adequately supervising their team.

Study Team (Site Trial Team)

Refers to the extended group of people involved in a research study or trial at the site. This includes the principal investigator and any additional members of staff who are involved in the set-up or conduct of the study e.g. associate investigators, trial coordinators, research nurses, research assistants, etc.

The Study Team is responsible for complying with the approved protocol, and performing their delegated study tasks and procedures within their scope of practice, training, and experience.

The PI is responsible for ensuring all members of the Site Trial Team are appropriately qualified by education, training, and experience, and have the necessary skills and abilities.

All Site Trial Team members are responsible for keeping records of their qualifications up to date.

All Site Trial Team members must complete training on, and receive information about, every trial they are working on, as relevant to their role in each study. Completed training must be documented in a trial-specific training log (e.g., MCTC017 Template | Study Staff Training Logs).

For Clinical Trials Specifically:

All staff working on clinical trials must have current ICH-GCP training. This training must be repeated every three years to maintain currency. The CRDO and A-CTEC courses are preferred for this.

Trials involving routine treatments or procedures often involve large numbers of healthcare professionals that are suitably qualified to undertake the trial by virtue of the prior education, training and experience, work within their routine scope of practice, and work to quality systems outlined in their professional codes of practice. Knowledge of GCP should therefore be provided in a way that is proportionate to the individual’s role and level of trial activity.

Send your GCP certificate to CRDO for safe-keeping and reminder purposes: [email protected].

For more detailed information on these requirements, see MCTC194a SOP | Trial-Specific Qualification, Education, and Training – Clinical Trials Team Members - Melbourne Children's Operational Document Database.

Consumer involvement in trials and research projects can make a significant difference to how well they meet their aims and objectives, and how impactful the translation of their results will be to their target population.

You need to plan for consumer involvement even though you have an external Sponsor. Things that you will need to plan for include:

• when and how consumer involvement will take place
• the recruitment of consumers and what type of consumer expertise suits your project and needs best
• the processes and policies for supporting consumer involvement
• the goals of consumer involvement at each stage
• Communicating effectively with your consumers

Contact the Consumer Involvement team at MCRI to discuss your needs: MCRI Intranet Consumer Involvement in Research; [email protected]

For more in-depth information on this topic: Toolkit