This toolkit and associated education modules are designed to provide sites with the information and resources to start and conduct teletrials.
Sponsors can expect that all sites planning to run teletrials have evidence of appropriate staff training to be provided during feasibility.
Clinicians are responsible for seeking out their own GCP training.
GCP certification is valid for 2-3 years depending on which program you have completed. This must be kept current and certificates provided to sponsors. Staff GCP certificates are kept in the study site file.
All staff must provide a CV in their trial site file showing their education and experience in conducting clinical trials. Sharing the Principal Investigator’s CV with the sponsor is an essential first step for start-up activities. CVs are kept in the study site file.
Transcelerate BioPharma has a widely accepted template available here.
Clinicians are responsible for seeking out their own Dangerous Goods Regulations training.
Any staff involved in shipping blood and tissue for research purposes must have a valid certificate renewed every 2 years and provide this to sponsors. These training certificates are kept in the study site file.
Sites will have a Site Profile (also known as a Site CV) available for distribution to study sponsors. This includes information about a site’s capabilities, staffing, infrastructure and clinical trials processes.
Generally, suitable sites for partnership have access to:
Under the teletrial model, satellite sites are not required to have access or resources to conduct all measures. For example, a site may be able to conduct 60% of all measures locally and the remaining 40% can be conducted at the primary site. This is still beneficial for the patient as they have potentially reduced their need to travel to the primary site by 60%.
For trials that are being run through General Practitioners or medical centres, the information would need to at least include medical and nursing staff, pathology, links to pharmacy and safety equipment available.
Example blank template based on Parkville Cancer Clinical Trials Unit (PCCTU)
Shared Investigator Portal (SIP) template
Regional Trial Network (RTN) Victoria has the site capabilities of eight cancer clinical trial units listed on their website here.
Sites have a set of standard operating procedures (SOP) in place available for reference by staff and sponsors. They specifically address how teletrials will run at the site.
The Australian National Standard Operating Procedures for clinical trials, including teletrials, are the recommended SOPs for conducting teletrials. Sites should have their own SOPs that are adapted from the National SOPs to include teletrials.
It is the responsibility of the principal investigator/delegate to ensure all essential documents are collected prior to clinical trial initiation and maintained throughout the study. All essential documents will be filed in study-specific Investigator Site File (ISF) that may be physical or electronic.
For Teletrials, site staff at the satellite site (SS) are responsible for the collection and maintenance of the specific SS documents as defined in their SOP and for the provision of copies of these documents as required to the Primary Site.
See National Standard Operating Procedures for Clinical Trials, including Teletrials, in Australia, Appendix 8 for a template.
A list of delegated duties will need to be detailed in the Teletrials Supervision plan (see section 4 in the left-hand menu for further information).
The Satellite Site (SS) will maintain a separate delegation log in the SS Site File. The SS signs a hard copy and retains the delegation log.
A copy is then emailed to the Primary Site (PS) where the Principal Investigator will approve the delegation of duties in person or electronically using an approved electronic signature.
The SS will retain the original but a copy of the log will be provided to the PS with each change of staff.
Examples of delegation logs:
PCCTU Delegation Log Role task examples
You can use these templates to develop your own site-specific documents; please note the example documents have been made available for educational purposes only.
The above documents and templates have been provided by the Parkville Cancer Clinical Trials Unit (PCCTU). The VCCC Alliance would like to thank and acknowledge PCCTU for its contribution to the Teletrial Toolkit.