Participant group | Topics discussed in interviews |
---|---|
Chief Investigator | The trial: History of the trial, details of the trial, current stage, successes, current and anticipated challenges |
TSC Chair | The TSC: Frequency of meetings, composition of TSC, reasons for selecting members, how Chair was selected and role in meetings, nature of the group’s decision-making and members’ involvement, examples of actioned group recommendations, impact of TSC, communication between TSC and TMG, relationship of and communication between TSC and other trial oversight committees, aspects of TSC that could be improved, recommendations for other trials regarding role of TSC |
TSC members | The trial: History of participation in the TSC, views regarding composition of the group and frequency of meetings, relationships with other members, value of TSC meetings, TSC’s role in decisions regarding trial, relationship of and communication between TSC, TMG and other trial oversight committees |
TSC meetings: Meeting organisation, Chair and leadership of meeting, communication during meeting, process of decision-making (positive aspects and challenges/difficulties, own and others’ contributions to decision-making), process of agreeing and assigning actions, communication of actions to other groups/trial personnel, how future TSC meetings could be improved | |
Trial funder representatives | Funders’ expectations and views of TSCs, process of selecting TSC, examples of TSC working well, examples where TSCs haven’t worked well, different models of TSCs, role of TSC Chair, role of Patient and Public Involvement (PPI), role of the trial funder, regulatory bodies, recommendations regarding TSCs |
Sponsor representatives | Sponsors’ expectations and views of TSCs, role of sponsor in trial, responsibilities of sponsor, relationship between sponsor, TSC and funder, challenges faced by trials, qualities of a TSC Chair, decision-making by a TSC, value of TSCs |