Recording harms in randomised controlled trials of behaviour change interventions: a qualitative study of UK clinical trials units and NIHR trial investigators

Table 1 Focus group and Interviewee characteristics

Participant characteristics^a	Interviews^b	Focus groups ^c
Trial managers	3	7
Chief or principal investigators	5
Data collectors	2
Quality assurance staff	2
Statisticians	2
CTU Directors or other senior staff	3
Sponsors	2
Patient and public representatives		6

^aIndividuals are counted under their main role or the role they identified however some had experience across multiple roles, e.g. Chief Investigator and oversight committee member
^bTen interviews conducted by KS with SHK; 3 interviews conducted by SHK; 2 interviews conducted with DP and SHK; 11 were individual interviews and 4 were paired interviews
^cCM conducted one pilot focus groups with Sheffield CTRU trial managers; DP, KS and SHK conducted the PPI focus group; DP and SHK conducted one trial manager focus group

ISSN: 1745-6215