Trial Steering Committee Training Workshop

Overall aims of the workshop

1. Provide a structured introduction (“primer”) to Trial Steering Committees (TSCs).
2. Clarify the role, remit, and responsibilities of TSCs, including key stakeholders’ perspectives
3. Increase expertise in resolving challenges for TSC members using real world situations in facilitated groupwork sessions
4. Promote good practice and up-to-date guidance on TSC functions
5. Strengthen trials community capacity and networking, particularly across Ireland and the UK

Learning outcomes

1. Describe the core Trial Steering Committee oversight role
2. Explain the specific responsibilities of TSC members and the Chair.
3. Summarise how funders (HRB, NIHR) and sponsors define a “successful TSC”
4. Understand how TSCs should engage with Clinical Trials Units and Clinical Research Facilities
5. Support the key role of Patient and Public Involvement (PPI) in TSCs
6. Apply TSC guidance to real world trial scenarios
7. Reflect on their own willingness and readiness to serve as TSC members or chairs

Rationale for the workshop

1. Clinical trials depend on robust, independent oversight.
2. There is a need to harmonise understanding and practice across Ireland and UK.
3. Many trialists are still uncertain about taking on TSC chair or member roles.
4. Complex oversight decisions are difficult and potentially have major consequences.
5. 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

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Host or Publisher Health Research Board - Trials Methodology Research Network (HRB-TMRN)