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.
You will need to produce a Site Profile (also known as a Site CV), and have it available for distribution to potential study sponsors. It should be updated with the latest information at least yearly due to staff movement.
This is your site’s brand or shopfront. It needs to include sufficient information about your 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.
Regional Trial Network (RTN) Victoria has the site capabilities of eight cancer clinical trial units listed on their website here.
You must have a set of standard operating procedures (SOP) in place and available for reference by staff and sponsors. They should specifically address how teletrials will run at your site.
If you are already running clinical trials at your site you will most likely have these documents already but you may need to revise them to include provision for teletrials. Pre-existing SOPs may be transferred or adapted from established sites.
The Australian National Standard Operating Procedures for clinical trials, including teletrials, are the recommended SOPs for conducting 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: