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.
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.
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.
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.
Sites should have privacy policies and procedures in place to ensure participant data is protected. Evidence of these needs to be provided to the sponsor and the RGO at each site.
Secure cloud-based data transfer between sites is recommended as being most efficient, rather than using postal services, email or fax.
The Office of the Victorian Information Commissioner (OVIC) is the regulator for dealings with personal information by public sector entities in Victoria. Find out more about their Information Security Resources and the medico-legal aspects of virtual care services for Victorian Public Health Services.
The negotiation of supervision plans can be expected to take from 6-12 weeks depending on the complexity of the trial protocol and existing trial unit infrastructure.
Fundamental questions that need to be answered within the supervision plan:
Please review the documents below where these broad questions have been addressed in detail and ordered into templates:
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
