Eligibility Criteria Guidelines
Purpose of Eligibility Criteria
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To define the subject characteristics required for meeting the study objectives
General Guidelines
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The criteria should be no more restrictive than is necessary to define the population of
subjects needed to meet the study objectives; to do otherwise unnecessarily decreases
number of subjects who would otherwise be eligible for the study and it increases the
likelihood that a protocol amendment will be required to rectify the situation
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List the criteria in a logical order whenever possible
o
First narrow the subject population to the disease (or other broad category) of interest
and then add additional qualifiers such as laboratory values
o
Group similar criteria such as laboratory parameters together
Random Ordering
1. Stage 1 breast cancer
1. Total bilirubin  ULN
2. ECOG performance status = 2
2. Age  18 years old
3. Age  18 years old
3. ECOG performance status = 2
4. Total bilirubin  ULN
4. Stage 1 breast cancer
5. Serum albumin ≥ 75% of LLN
5. Serum albumin ≥ 75% of LLN
If “Age  18 years old” is written as an inclusion criterion, do not include “Age  18 years
old” as an exclusion criterion
Pay attention to detail
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Logical Ordering
The same criteria should not be stated as both an inclusion and exclusion criterion
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If, for example, an MRI scan taken 4 weeks prior to the start of therapy is adequate,
don’t specify that it needs to be taken within 2 weeks prior to the start of therapy
“Age > 18 years old” is not the same as “Age  18 years old”; the former excludes 18
year olds while the latter includes 18 year olds
Consider using “institutional limits” rather than actual values, especially for multi-institutional
studies where there may be variation in various laboratory test parameters
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“Total bilirubin  institutional upper limit of normal (ULN)” rather than “Total bilirubin  1.3
mg/dL”

Write the criteria as a positive statement rather than as a negative statement (ie, state the
criteria in terms of what you would like the subject to be, rather than what you would not like
the subject to be
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Use “Pregnant or nursing” as an exclusion criteria rather than “Not pregnant or nursing”
as an inclusion criteria
Inclusion Criteria section
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Include an introductory statement that the potential subjects must meet all of the
inclusion criteria to be eligible to participate in the study
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Individual inclusion criteria should be written such that an affirmative (yes) response is
required for each item in order for the potential subject to be deemed to have met the
inclusion criteria
Exclusion Criteria section
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Include an introductory statement that a potential subject meeting one or more of the
exclusion criteria will not be eligible to participate in the study
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Exclusion criteria should be written such that an affirmative (yes) response to any item
deems the potential subject ineligible for the protocol