This page provides an overview of challenges and solutions in the ongoing management of Teletrials.
Regular communication between study teams at the Primary Site (PS) and Satellite Sites (SS) is essential to the continued success of running a Teletrial. The frequency of meetings should be documented in the supervision plan.
The template below, developed by the Parkville Cancer Clinical Trials Unit (PCCTU), may be helpful to facilitate and record minutes of these ongoing meetings between the PS and SS.
Teletrial Oversight Meeting Template
The primary site should also have regular correspondence with the sponsor every 4 to 6 weeks.
One of the main reasons to set up a Teletrial at an SS is to increase the recruitment capabilities of the trial. A recruitment plan should be shared between the sponsor and participating sites prior to the trial commencing and should be reviewed during trial meetings.
Consenting procedures should also be documented in the supervision plan and the sites standard operational procedures. The European Clinical Research Organisation Federation (EUCROF) has developed a comprehensive guide for sites using electronic informed consent in clinical trials. This document explains how e-consent can be used in Teletrials:
Electronic Informed Consent Implementation Guide
Screening specifics and procedures need to be negotiated and documented in the supervision plan Some key considerations to think about when setting up a Teletrial include which screening procedures will be performed at the SS and PS, whether blood or sample biopsies need to be sent from the SS to a central clinical lab and appropriately allocating payments according to which sites perform tasks and enters data.
PI/AI review of participants via video or telephone is an integral part of ongoing review in teletrials. See below for some helpful resources on using and implementing telehealth.
