Resources and SOPs should be used as a guide only, to be adapted, adopted and controlled via the organisation’s HREC Office (or equivalent).
Frequently Asked Questions
These questions were collated from webinar participants.
Standard operating procedure
Procedure for documenting training that has been undertaken by members of the study team.
Applies to the principal investigator and to all members of the study team, for all teletrials undertaken at site(s).
Variations to normal clinical trial procedure when undertaking a teletrial, applies to the principal investigator, sub-investigators and to all members of the study team.
Procedure for obtaining written informed consent for participation in a clinical trial.
Applies to all clinical trial investigators who obtain informed consent from clinical trial participants or their legal acceptable representative, in addition to participants at satellite sites, as well as all members of the study team.
Delegating clinical trial related duties undertaken by members of the study team.
Applies the principal investigator and to all members of the study team, including study team members at any teletrial satellite site.
Clinical trial feasibility and start-up procedure, undertaken at sites, applies to all clinical trials coordinated by the site, including any trials undertaken via the teletrials model.
Procedure for obtaining ethical and governance approval for new and existing clinical trials.
This SOP is applicable to the study team and external providers engaged in the conduct of clinical trials, including the study team at all teletrial satellite sites.
Procedure for the management of all aspects of investigational product, either medicinal product or device. Management includes but is not limited to the receipt, storage, accountability, preparation and administration, shipment and destruction of investigational product.
This SOP applies to all members of the study team involved in the handling and shipping of investigational product, including all the teletrial satellite site study team.
Facilitating a regulatory inspection, sponsor or HREC initiated audit, procedure and actvities applies to the principal investigator and all members of the study team including teletrial satellite site staff as required.
Handling and shipping of infectious substances in clinical trials procedure, applies to all members of the study team involved in the handling and shipping of central samples, including all the teletrial satellite site study team.
Procedure for version control and tracking of amendments to documents used by the site.
This SOP applies to all documents used in the administration of clinical trials (including teletrials), including but not limited to SOPs, work practice guidelines, fast facts, templates and training presentations.
Procedures relevant for the collection and maintenance of essential documents for clinical trials coordinated by the site and, where appropriate, satellite sites (SS) involved in teletrials.
Applies to all clinical trials coordinated by the site and where the site is participating in a teletrial.
Procedure for archiving essential documents for clinical trials coordinated by the site as required from the completion of the clinical trial, to the subsequent transfer of essential documents to the archiving facility.
Applies to all clinical trials coordinated by the site including teletrials.
Management of all external safety information procedure, applies to all clinical trials coordinated by the site, including all teletrials.
Guideline
List of terms and acronyms used in the VCCC Teletrials SOPs.
Slight variations to the protocol and Participant Information Sheet and Consent Form (PICF) will be needed for a teletrial to show how patient care under the teletrials model will be carried out, particularly in regards to trial visits.
Template
For an investigator-initiated teletrial, the Clinical Trial Activities Agreement for implementation in the case of an Investigator Initiated Study by Teletrial should be used which is signed by the Primary site and each teletrial satellite site.
This agreement was developed by the VCCC, subcontract would not be required for investigator-initiated teletrials using this template.
In addition to the Clinical Trial Research Agreement (CTRA), a subcontract will need to be in place between the primary and satellite site to cover the research activities conducted under the teletrials model.
In Victoria, the CTRA subcontract for studies conducted under a teletrials model should be used between the primary and each teletrial satellite site. (NB: this subcontract is not required for investigator-initiated teletrials using the VCCC CTRA IIT template).
A supervision plan is a core document of a teletrial as it outlines key roles and responsibilities of study personnel at both the primary and satellite site.
The VCCC has developed a supervision plan template tailored to the Victorian context, based on the Queensland Health Supervision Plan template.
Templates
An appropriate Clinical Trials Research Agreement (CTRA) must be in place for clinical trials (including teletrials), for sponsored trials in Victoria the head agreement between the sponsor and primary site will remain the Medicines Australia standard CTRA with a variation to schedule 7 to indicate that the study is being run as a teletrial.
Standard operating procedures
This compendium, including SOPs, has been developed by Queensland Health to incorporate the recommendations from the Clinical Oncology Society of Australia’s (COSA) Australasian Tele‐trial Model – A National Guide to Implementation.
NB: these documents are specific to Queensland and would need to be appropriately adapted to other states in Australia.
Information
VMIA is the Victorian Government insurer, and provides public hospitals with medical indemnity insurance including for clinical trials.
The VMIA have outlined coverage for teletrials, including scenarios for public to public hospitals, public to private hospitals and private to public hospitals.
Matrix
In the teletrial model, the primary and satellite sites are paid based on the delegated tasks they undertake.
COSA have developed a payments matrix to help organisations to decide on the distribution of funding across the two sites.