Table 3 Uncertainties or knowledge gaps identified by research professionals and developments required to facilitate effective Remote Trial Delivery
Identified uncertainties, knowledge gaps and developments required | |
|---|---|
Technology | Specific trial elements will need technological input: • Electronic site files • Integration between electronic systems • Digital consent • Data security, storage and access • Digital signatures |
Training and skill development | Required for both research teams and participants |
Communication | Digital communication will need to be facilitated: • With participants • Between participants • Between researchers • With the NHS, including electronic patient records and communication with healthcare workers |
Validity | The validity of specific elements of remote delivery will need to be established, including: • The consent process • Interventions • Study measures |
Participant factors | It will be important to create an evidence base to improve understanding of aspects relevant to patients and carers, including: • Safety • Acceptability • Bias/exclusion • Support • Impact on recruitment • Valid consent • Retention in trials • Return to future trials |
Governance | Governance procedures will be required to ensure: • Standardisation • Quality • Data security • Sponsor and regulator support for remote processes |
Resources | A comparison of the resources required for remote delivery versus face to face should include: • Time compared to “traditional” model • Cost compared to “traditional” model • “Buy-in” from sponsors |