8. Ongoing trial management
This page provides an overview of challenges and solutions in the ongoing management of Teletrials.
Telehealth resources for Teletrials
The European Clinical Research Organisation Federation (EUCROF) has published an implementation guide for sites transitioning to electronic informed consent (e consent) in clinical trials which can be used to assist with using econsent in Teletrials:
Electronic Informed Consent Implementation Guide
The Australian College of Rural and Regional Medicine (ACRRM) provides guidelines to assist with the establishment of quality telehealth services which can be implemented in a Teletrial.
Telehealth Framework and Guidelines
Pharmacy in Teletrials
Telepharmacy is the use of information and communications technology to facilitate pharmacists and patients interacting across different locations. Telepharmacy can be used to assist with the dispension and delivery of medication to participants in a Teletrial.
The primary Investigator is responsible for all dosing and medication management of the Investigational Medicinal Product (IMP) for a trial. Below are some key things to think about in terms of medication management in a Teletrial:
- The process of how doses of IMP are adjusted and dispensed should be documented in the supervision plan.
- Sites also need to agree on how medications are managed by the pharmacy staff at each site.
- If a Satellite Site (SS) does not have a specific trials pharmacist, then arrangements need to be made for dispensing from the Primary Site (PS) and the delivery to either the SS.
- If participants are given medications to administer at home, appropriate education and training must be given by the study team on how to appropriately administer.
- If mobile nursing services are used to administer intravenous or subcutaneous medication, the staff need to be given the contact information of the study team and information about the IMP and any possible drug reactions or adverse events.
- Mobile nursing staff so not need to be on the study delegation log as they are carrying out duties within their scope of practice.
Adverse event management
Participants should be treated immediately at their local SS where possible following an adverse event (AE) and then transferred to a PS if further interventions are required.
The responsibilities and methods for communicating and reporting AEs and serious adverse events (SAEs) must be documented in the supervision plan. This clarifies which sites are responsible for reporting to the sponsor, RGO or HREC.
Monitoring and Auditing
Sites should agree and document the process for monitors and auditors to access the Site Master File (SMF) and study-related documentation in the supervision plan. The location of trial documentation may be dependent on how the trial has been set up (eg. whether sponsor intends to monitor SS directly). If the sponsor conducts SS monitoring visits, liaison with the SS coordinator and Pharmacist should be arranged. The PS also needs to be made aware of all visits and PS staff are invited to attend via telehealth.