Study procedures

Screening and eligibility assessment

Screening and eligibility involves checking whether potential participants meet the inclusion and exclusion criteria set out earlier. Criteria will need to be checked with participants before they are officially enrolled on the study. Sometimes this occurs before informed consent, and sometimes afterwards depending on the study design. Eligibility assessments can either be done with a tick list that participants complete to confirm that they do not meet any of these criteria, or the criteria may be checked by a researcher by talking with the participant. The process planned for a study should be outlined in this section.

Sometimes screening involves accessing patient medical records to identify potentially eligible participants and invite them to take part. If patient medical records are being accessed, details of who will access them (whether somebody within or outside the care team), how patients’ confidential data will be protected, and whether patients will be informed that they are being screened should be carefully outlined.

There are different ways of selecting or ‘sampling’ the participants to be involved in a study. Some of these are outlined in Chapter 10. For a comprehensive overview of different sampling strategies, Sampling Essentials by Johnnie Daniel is recommended.(1)

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