EligibilityCriteria.pdf

6/15/2021 MAIN_MSN5300_FN2 R_2021-GRAD2: Eligibility Criteria

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Eligibility Criteria
refer to both inclusion and exclusion criteria
set the stage for the population that the study will examine, as they include characteristics that must be shared by all study
subjects as well as exclude characteristics that may confound study results 
affect who participates in the study, the way the study is conducted, and, consequently, the results
includes both inclusion and exclusion criteria; may be comprised of age, sex, medical history, current health status, severity
of the disease being studies, and concomitant medications
eligibility criteria help to keep study volunteers as safe as possible
make the study more meaningful by selecting subjects most representative of the study population
set the stage for study approval by regulatory agencies 

Inclusion Criteria

characteristics that a person must possess in to participate in a study
typically includes personal characteristics such as age and gender as well as disease characteristics such as the specific
symptoms a person is experiencing
specific criteria help to select participants who are similar in characteristics or who have a similar disease course in to
monitor their reaction to a specific treatment in a measureable way
meeting all of the inclusion criteria is 1 step in the qualification process for enrollment; however, subjects must also
successfully not meet any of the exclusion criteria as well

Exclusion Criteria

if any of the exclusion criteria apply to a subject, he or she would not be considered for the study
target specific characteristics such as too severe disease, complications of disease, other medical conditions, and previous or
concomitant treatment
identifies specific characteristics that may 1. put the participant at risk; 2. limit potential efficacy of a study treatment; 3.
adversely affect the person’s condition in a way that makes participation dangerous; 4. make the individual less likely to
successfully complete the study, or 5. potentially confound study results
weighing pros and cons of more restrictive vs less stringent eligibility criteria plays a role in the rate of subject enrollment:
ie., less stringent enrollment requirements may be easier to enroll but may result in a more heterogeneous patient
population and leave the study open to confounding factors versus more restrictive enrollment requirements may benefit a
trial by making endpoints easier to reach but may make enrollment more difficult. 

Ref:
Yadav S.K., Singh S., Gupta R. (2019). Sampling Methods. In: Biomedical Statistics. Springer, Singapore. 

Last modified: Sunday, June 13, 2021, 5:04 PM

6/15/2021 MAIN_MSN5300_FN2 R_2021-GRAD2: Eligibility Criteria

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