Background: The Teletrial Supervision Plan is a critical document which defines the allocation of clinical trial activities to the satellite site and method of supervision by the Principal Investigator. The national harmonisation of this key document was identified by stakeholders as a high priority in 2023.
Objective: To develop a nationally harmonised Teletrial Supervision Plan that is easy to use.
Methods: A comprehensive review of existing supervision plan templates was conducted by the Australian Teletrial Program Editorial Group. The MoSCoW prioritisation technique was employed to systematically identify essential topics to achieve consensus on required details and wording. Qualitative data was collected from Systems Usability Scale Survey’s and written feedback from clinical trial stakeholders for thematic analysis.
Results: A total of 22 responses were collected with highest user representation reported as Clinical Trial Coordinator role (n=9, 40.91%), Public Hospital location (n=18, 81.82%) and new users (0-3 Teletrials) (n=13, 59.09%).
Utility statements such as ‘I found the various components in the Teletrial Supervision Plan were well integrated’ received largely positive responses (Agree: 50.0%; Strongly Agree: 22.7%).Theme categorised feedback suggested greater comparative efficiency, clarity and flexibility with the addition of user interface elements as indicated by responses such as the revised ‘version made it clear where responsibilities were’, and ‘The use of drop-down options and free text boxes ensures flexibility and concise coverage of clinical trial requirements’. One user commented that the Teletrial Supervision Plan could be overwhelming for first-time users.
Conclusion: The Teletrial Supervision Plan has been produced through national collaboration across specialty areas and provides a straightforward and consistent approach enabling teletrials across jurisdictions. The endorsed nationally harmonised Teletrial Supervision Plan has demonstrated user acceptability and usability. Supplementary educational information may be of assistance for first-time users.