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Table 2 Interview topic guides (summary)

From: ‘We all want to succeed, but we’ve also got to be realistic about what is happening’: an ethnographic study of relationships in trial oversight and their impact

Participant groups

Topics discussed in interviews

Chief Investigator, Trial manager

The trial: history of the trial, details of the trial, current stage, successes, current and anticipated challenges The Trial Steering Committee/Trial Management Group (TSC/TMG): expectations of TMG/TSC, composition of TMG/TSC, selection of members and chairs, nature of the group’s decision-making and members’ involvement, examples of actioned group recommendations, impact of TMG/TSC, communication between TSC and TMG, relationship and communication between trial oversight committees and with funder

TSC members

The trial: history of participation in the TSC, views of TSC, relationships with other members, value of TSC meetings, TSC’s role in decision-making, relationship and communication between TSC, TMG and other trial oversight committees TSC meetings: meeting organisation, Chair and leadership, communication during meeting, decision-making, agreeing and assigning actions, communication of actions to other groups/trial personnel

TMG members

The trial: history of participation in the TMG, views of TMG, relationships with other members, views of TMG and TSC, value of TMG/TSC, TMG/TSC role in decision-making, relationship and communication between TSC, TMG and other trial oversight committees TMG meetings: meeting organisation, Chair and leadership, communication during meeting, decision-making, agreeing and assigning actions, communication of actions to other groups/trial personnel, role of Patient and Public Involvement (PPI)

Trial funders

Funders’ expectations and views of TMGs/TSCs, process of selecting TSC, examples of trial oversight working well, examples where trial oversight has not worked well, different models of TSCs, role of TSC Chair, role of PPI, role of the trial funder, regulatory bodies, recommendations

Sponsors

Sponsors’ expectations and views of TMGs/TSCs, role of sponsor in trial, responsibilities of sponsor, relationship between trial oversight committees, sponsor and funder, challenges faced by trials, role and value of TMGs/TSCs

  1. TMG Trial Management Group, TSC Trial Steering Committee, PPI Patient and Public Involvement
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Trials

ISSN: 1745-6215