4. Supervision Plans
Supervision Plan Overview
The requirement for a supervision plan is a key difference in the teletrial model from existing practice.
Once a Primary Site (PS) and Satellite Site (SS) have agreed to run a trial and have been selected by the sponsor, a negotiation between the two will need to proceed to determine who is responsible for each trial-related activity. The results of the negotiation are documented in the supervision plan. A supervision plan is required for each site.
The Principal Investigator (PI) for a clinical trial conducted using the teletrial model has the same responsibilities under ICH-GCP as required for any clinical trial.
The PI oversees all aspects of the trial, whether the activity is completed at the primary site or satellite sites and is responsible for ensuring the safety of all participants in the trial.
A delegation log is still required at each site as the supervision plan does not replace this.
Duties may be delegated by the PI, but the PI has overall accountability for the clinical trial activity completed at the satellite site and must ensure all personnel working on the trial are adequately trained in all aspects of the clinical trial according to ICH-GCP.
The supervision plan is a live document and can evolve as clinical site capacity changes over the duration of the trial. HRECs and RGOs may ask for the supervision plan to be submitted as part of the overarching and local applications.
Supervision Plan Negotiation
The negotiation of supervision plans can vary depending on site experience, the complexity of the trial protocol and existing trial unit infrastructure.
Fundamental questions that need to be answered within the supervision plan:
- Who will be responsible for each task at the sites?
- How will communication between sites be documented for trial purposes and accountability at audit?
- How will education of staff be implemented and recorded at each site?
- Who is responsible for research governance processes at each site?
- How will the process of recruitment and consenting work at each site?
- How will randomisation occur?
- Who is responsible for safety reporting?
- How will funds be managed and disbursed?
- How will the investigational product be received, stored, dispensed, administered and destroyed?
- How will screening work between sites?
- Who is responsible for data / eCRF entry?
- Who is responsible for participant appointment management?
- Who will make clinical care decisions?
The VCCC Alliance is contributing to a national supervision plan template (through the Australian Teletrial Program) currently under development. This will be available below as soon as it is available.
Below are current templates that are suitable for supporting the development of a supervision plan:
Supervision Plan Template
Supervision Plan Template for sites with clinical trials experience_v5.docx
Supervision Plan Template for sites with medical specialist but no trials experience_v6.docx
Supervision Plan Template for sites without medical specialist_v5.docx
Sample supervision plan in Australian National Standard Operating Procedures, Appendix 5, p71.
Australian National Standard Operating procedures for clinical trials including teletrials
Secure data transfer
A process of secure data transfer needs to be agreed upon between sites and enabled by infrastructure.
Conducting a trial between two or more sites requires the secure transfer of information between all partners. Sites need to agree and then implement appropriate computer software and infrastructure to enable this to happen. Primary Site and Satellite Site Study Site Files can use validated data storage systems such as TrialDocs. To minimise the use of ‘wet-ink’ documents, a program such as Adobe Sign may be used.
TrialDocs implementation to trial sites throughout Victoria has been supported extensively by the VCCC Alliance.
If other service providers are chosen for secure file transfer, sites should ensure that the provider's servers are located in Australia to comply with national legislation regarding data sovereignty.
Privacy and Confidentiality
Privacy Policies and Procedures: ensure participant data protection with comprehensive privacy policies and procedures. Provide evidence of these to the sponsor and the RGO at each site.
Secure Cloud-Based Data Transfer: opt for secure cloud-based data transfer between sites for efficiency and security. Avoid using postal services, email, or fax.
The Office of the Victorian Information Commissioner (OVIC): OVIC regulates personal information handling by public sector entities in Victoria. Explore their Information Security Resources and the medico-legal aspects of virtual care services for more information.