Sponsorship Risk Assessment and Management
Who can be a sponsor?
Australia's Therapeutic Goods Administration defines a sponsor as an individual, company, institution, or organisation which takes responsibility for the initiation, management, and/or financing of a clinical trial.
Clinical trials with regulated therapeutic goods, including medicines, devices and biologicals, have additional regulatory requirements for sponsors with regards to the supply of product (manufacture, importation and labelling) and reporting of safety issues. These responsibilities depend on where the trial is conducted and it is important that the Sponsor-Investigator is aware of the relevant legislation at State or Territory and National level.
For trials conducted in Australia, details about the regulatory requirements for conducting clinical trials with 'unapproved' therapeutic goods are explained in the TGA: Australian clinical trial handbook: Guidance on conducting clinical trials in Australia using 'unapproved' therapeutic goods.
Whether the sponsor is a commercial company or a non-commercial institution (for example a hospital or university), the requirements for conducting clinical trials, in accordance with Good Clinical Practice (GCP) or other regulatory requirements, are the same. However when an institution agrees to take on the role of sponsor for an investigator-initiated trial, they need to be assured that all risks have been identified and there is a plan to manage/mitigate the risks.
Applying for sponsorship from the host institution
When an investigator plans to conduct an investigator-initiated trial, they must seek sponsorship by their host institution or organisation.
Institutions should have a standard operating procedure that describes the process for requesting and approving sponsorship. The procedure may include (but not be limited to):
- Risk assessment by the sponsoring institution
- Requirements to be met by the Sponsor-Investigator
- Ongoing conditions of sponsorship
- Conditions under which sponsorship may be withdrawn/revoked
- Delegation of sponsor responsibilities between the sponsoring institution and the Sponsor-Investigator
Sponsorship needs to be reviewed throughout the trial lifecycle
The review of sponsorship by the host institution/organisation is a continuous process. The Sponsor-Investigator is responsible for keeping the Sponsorship Committee informed in a timely manner with any changes to the initial risk assessment. This includes, but is not limited to:
Different approaches to sponsorship
The process that sponsoring institutions use to manage oversight of trials where they have delegated sponsor responsibilities to the Sponsor-Investigator, will vary depending on the size and nature of the host institution.
Level 1 Institutional Sponsorship Application Process - No Committee
Download an infographic of Level 1 Sponsorship Process with No Committee
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 application for sponsorship is submitted to the institution’s Research Office with a draft protocol that has already had peer review and input from a trial statistician. The application for sponsorship may be approved before the Investigator can submit an application for ethical and/or governance review, or alternatively, the institutional process may permit ethics review to occur in parallel with sponsorship review with ethics approval pending on the outcome of the sponsorship review.
The minimum number of areas of risk to be considered before providing sponsorship include:
- Medicine and device trials – if the medicine or device is unapproved and trial being conducted under a Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX)
- Contracts with participating sites
- Participant population
- Staff – available, appropriate training/experience
- Monitoring clinical trial conduct and safety
- Data Management
- Supporting departments
An example of an institutional sponsorship approval process using a minimal approach is Request for Melbourne Health to Act as Sponsor.
Level 2 Institutional Sponsorship Application Process - Full Committee
Download an infographic of Level 2 Sponsorship Process with Committee
If the host institution/organisation conducts high risk trials, it may be more appropriate that a sponsorship committee is formed to provide an appropriate level of assurance and adequate risk assessment.
This process will involve a committee made up of representatives from the organisation, such as the grants team, legal team, and the research governance office.
This committee may meet to approve sponsorship in parallel to the ethics committee and so be separate from the ethics approval process. Alternatively, the ethics approval may be pending on review by the sponsorship committee. So the committee is a sub-committee that feeds into the overall approval process for the organisation.
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.
Areas of risk that may be considered by a Sponsorship Committee include:
- Data and samples
- Harm to participants
- Staff experience and skills
- Contracts and indemnity
- Impact of research question
- Plans for commercialisation of the investigational product
Examples of an institutional sponsorship process, associated sponsorship application form and a Certificate of Sponsorship (that would be issued by the sponsoring institution):