![]() To illustrate the development of the eligibility criteria, see Table 1. From this smaller sample, researchers can generalize findings to the larger target population in order to improve understanding of disease processes, new treatment options, and sociodemographic trends. The eligibility criteria should be designed to select a representative sample (the accessible population) from the target population. The development of eligibility criteria must also include a review of the potential safety concerns of an intervention, such as interference with a participant's current medication or concurrent health condition. Common elements that determine suitability for participation in a study are age, sex, medical condition, specific disease examined, and medications taken. DESIGNING THE ELIGIBILITY CRITERIAĪll clinical research protocols must have an eligibility criteria section that includes both inclusion criteria and exclusion criteria. The choice of study participants also involves factors related to feasibility, including the time and money needed to obtain the required number of participants. The clinical and demographic characteristics of the accessible population are established using predetermined eligibility criteria. The accessible population is the geographically and temporally classified subset who are available for study participant recruitment. The target population is the group of people who share a common condition (disease process) or characteristic the researcher is interested in studying. This article is an introduction to designing study eligibility criteria and recruiting study participants.ĭefining the target population is an essential part of protocol development because it ensures the study participants are well suited to the research question. The first article in this series (“How Does Research Start?” October 2020) was about how to identify a topic of interest and develop a good research question. ![]()
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