Table 2 Additional documents to enhance the quality of trials in low resource settings
Document | Contents | Use |
|---|---|---|
Interviewer contracts | Names of interviewer, duration of recruitment period, roles and responsibilities of the investigators and interviewers including number of participants to be enrolled | Clearly defines roles and responsibilities of the concerned parties. Sets individual targets for interviewers |
Recruitment log | Dates, number of forms filled, interviewer names, problems encountered, refusals and non-eligible subjects | Easily exploitable enrolment data, quality control of data, a good feedback mechanism |
Trial contact list | Names, functions and phone numbers of everybody involved in the trial | Handy contact list, permits real time communication with interviewers, coaching and encouragement |
Interviewer follow-up form | Names of participants, dates of enrolment, date of next visit | Essential for interviewers to track patients and prepare for follow-up visits |
Participant feedback log | Dates, times, contact addresses and content of feedback from participants | Provides ongoing monitoring of intervention Useful data for providing a context for later findings |