Sponsor Team

Sponsor, Sponsor-Investigator and Central Coordinating Team 

Sponsor

MCRI sponsors clinical trials either led by MCRI/RCH researchers or where MCRI/RCH acts as the local Australian Sponsor for an overseas Sponsor. See MCTC037b Standard Operating Procedure: MCRI Sponsorship Application Process for Investigator Initiated Trials and MCRI Trial Sponsorship for further information.

The trial Sponsor is responsible for the initiation, management and financing of the trial and carries the medico-legal responsibility associated with its conduct. All aspects of which must be in accordance with GCP, the National Statement, the protocol approved by the approving Human Research Ethics Committee (HREC) and any external funding body.

If the trial requires a Clinical Trial Notification (CTN) to the TGA, MCRI will be the Sponsor. See Approvals & Registration for further details.

 

Sponsor-Investigator

For MCRI-sponsored investigator-initiated trials, MCRI delegates many sponsor responsibilities to the lead MCRI/RCH researcher. This individual is the Sponsor-Investigator, a term that reflects their dual role of Sponsor and Investigator.

The Sponsor-Investigator may also delegate some sponsor responsibilities to other organisations involved in the trial, for example monitoring may be delegated to a Contract Research Organisation (CRO), or if there is a need, a Local Sponsor for overseas sites. See Oversight and Delegation (below) for further information.

Sponsor-Investigator responsibilities are clearly defined in the TGA Integrated Addendum to ICH E6 (R1): Guideline for Good Clinical Practice ICH E6 (2) 2016 – Annotated with TGA comments and Melbourne Children’s MCTC182 SOP - Sponsor-Investigator Responsibilities in MCRI-sponsored IITs.

Melbourne Children’s have a suite of Standard Operating Procedures, guidance and templates to support Sponsor-Investigator’s and their teams meet their Sponsor responsibilities. These are all accessible via the Melbourne Children’s document library METIS.

 

Coordinating Principal Investigator

All clinical trials conducted within a geographic region/jurisdiction must have a local entity as the Sponsor. This includes external Sponsors based overseas who wish to conduct a trial in Australia.

MCRI acts as the Australian Sponsor for trials with an overseas non-commercial Sponsor and where an MCRI/RCH researcher is the Coordinating Principal Investigator (CPI) for the Australian site(s). The CPI is the Principal Investigator for the MCRI/RCH site and has the additional responsibility for coordinating the study across all participating sites in Australia. The MCRI/RCH CPI responsibilities must be documented using MCTC168 Template Roles & Responsibilities Matrix and usually include submitting the ethics application to the reviewing HREC, obtaining MCRI Sponsorship, arrange CTN (if applicable) and communicating outcome of all approval/notifications to the participating sites (if a multi-site trial in Australia).

 

Central Trial Coordinating Team

The Sponsor-Investigator is supported by their team. At Melbourne Children’s, we refer to this group as the Central Trial Coordinating Team. Key personnel in the team include (but are not limited to):

    • Sponsor-Investigator
    • Other Investigators listed on the protocol
    • Clinical Trial Manager/Coordinator
    • Biostatistician
    • Data Manager(s)
    • Database Manager/Programmer
    • Trial Monitor
    • Medical Monitor

The Central Trial Coordinating Team is responsible for complying with the approved protocol, trial-specific SOPs, Melbourne Children’s SOPs, ICH GCP and any relevant local/national/international regulatory requirements. Team members are responsible for performing their delegated study tasks and procedures within their scope of practice, training, and experience.

The Sponsor-Investigator, members of the Central Trial Coordinating Team, and any other person/party delegated Sponsor responsibilities for the trial, must be appropriately qualified and trained for the tasks they have been assigned.

All members of the trial team are responsible for documenting evidence of training relevant to their role on the trial using a training log and filing all training certificates in the Trial Master File. Use MCTC017 Template Study Staff Training Logs. The documents must be kept up-to-date and available for review by Auditors and Inspectors.

Training includes trial-specific training and Good Clinical Practice training. The Sponsor-Investigator is responsible for ensuring all members of the Central Trial Coordinating Team are trained before they commence their assigned tasks.

GCP training (training to the ICH GCP standard) is mandatory for all team members as per RCH0498 Investigators Responsibility in Research Procedure.

IMPORTANT: Depending on the nature of the trial, members of the Central Trial Coordinating Team may need to complete a “full” GCP course that covers both Site and Sponsor responsibilities. See MCTC194a SOP Clinical Trial Staff Qualifications, Training Records, and Capability for further information about training requirements.

The Sponsor and Sponsor-Investigator may delegate Sponsor responsibilities to others but they must retain oversight of all delegated roles and responsibilities.

The MCRI Sponsorship Committee is responsible for ensuring oversight of Sponsor responsibilities delegated to the Sponsor-Investigator. The Sponsor-Investigator is responsible for ensuring oversight of any Sponsor responsibilities delegated to a third party. e.g. external Sponsor(s) if MCRI conducting a trial overseas, or a third party service provider, e.g. Contract Research Organisation, external laboratory.

Refer to Melbourne Children’s MCTC183 SOP - Delegation of Sponsor Responsibilities in MCRI-sponsored IITs for Sponsor and Sponsor-Investigator responsibilities and procedures for delegation, third party vendor assessment, documentation of roles and responsibilities and oversight. Also see Vendor Management.

Consumers may also be part of the Central Trial Coordinating Team, contributing to the design and conduct of the research. They may also be involved in the collection and analysis of trial data and dissemination of results.

Involving consumers in MCRI investigator-initiated trials is recommended. When the consumers are children or young people, there may be additional considerations needed to:

  • protect consumer privacy, particularly around conditions that may be associated with stigma or may lead to assumptions about their health
  • avoid missing school, other activities
  • receive/give information

 

The Sponsor-Investigator and Central Trial Coordinating Team should develop procedures to support and protect privacy of children and young people who are partners in the research.

The trial protocol should describe the level of involvement, e.g. consultation, collaboration, child/adolescent-led with support of adults.

For further guidance and support about consumer involvement in clinical trials, contact the Consumer Involvement team at MCRI to discuss your needs: MCRI Intranet Consumer Involvement in Research; [email protected].

 

Other useful resources include: