Overall aims of the workshop
- Provide a structured introduction (“primer”) to Trial Steering Committees (TSCs).
- Clarify the role, remit, and responsibilities of TSCs, including key stakeholders’ perspectives
- Increase expertise in resolving challenges for TSC members using real world situations in facilitated groupwork sessions
- Promote good practice and up-to-date guidance on TSC functions
- Strengthen trials community capacity and networking, particularly across Ireland and the UK
Learning outcomes
- Describe the core Trial Steering Committee oversight role
- Explain the specific responsibilities of TSC members and the Chair.
- Summarise how funders (HRB, NIHR) and sponsors define a “successful TSC”
- Understand how TSCs should engage with Clinical Trials Units and Clinical Research Facilities
- Support the key role of Patient and Public Involvement (PPI) in TSCs
- Apply TSC guidance to real world trial scenarios
- Reflect on their own willingness and readiness to serve as TSC members or chairs
Rationale for the workshop
- Clinical trials depend on robust, independent oversight.
- There is a need to harmonise understanding and practice across Ireland and UK.
- Many trialists are still uncertain about taking on TSC chair or member roles.
- Complex oversight decisions are difficult and potentially have major consequences.
- TSC guidance is evolving.
Workshop timetable:
09:30–10:00 | Arrival, Refreshments & Registration
10:00–10:10 | Welcome & Introduction
10:10–10:35 | The Role of TSCs in Trial Oversight
10:35–10.55 | The Chair as a “Critical Friend”
10.55–11:15 | Patient and Public Involvement in TSCs
11:15–11:30 | Coffee Break
11:30–12.10 | Funder & Sponsor Perspectives
12.10-12.45 Breakout Session 1: TSC Sample Size and Recruitment Scenario
12:45–13:40 | Lunch & Group Photograph
13.40–14:25 | TSC Experiences
14:25–14.40 | Coffee Break
14.40–15:20 | Breakout Session 2: IDMC recommendation to the TSC Scenario
15:20–15:40 | Group Discussion
15:40–15.55 | Closing Remarks
15:55 | Close