Eligibility Criteria Guidelines

Purpose of Eligibility Criteria

·  To define the subject characteristics required for meeting the study objectives

General Guidelines

·  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

o  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

·  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

Logical Ordering / Random Ordering
1.  Stage 1 breast cancer / 1.  Total bilirubin £ ULN
2.  ECOG performance status = 2 / 2.  Age ³ 18 years old
3.  Age ³ 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

·  The same criteria should not be stated as both an inclusion and exclusion criterion

o  If “Age ³ 18 years old” is written as an inclusion criterion, do not include “Age 18 years old” as an exclusion criterion

·  Pay attention to detail

o  “Age > 18 years old” is not the same as “Age ³ 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

o  “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

o  Use “Pregnant or nursing” as an exclusion criteria rather than “Not pregnant or nursing” as an inclusion criteria

·  Inclusion Criteria section

o  Include an introductory statement that the potential subjects must meet all of the inclusion criteria to be eligible to participate in the study

o  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

o  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

o  Exclusion criteria should be written such that an affirmative (yes) response to any item deems the potential subject ineligible for the protocol