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The Implications of Modifying Study Eligibility Post ...
The Implications of Modifying Study Eligibility Post-Initiation of RecruitmentCOLLEEN ALLEN MPH CCRAR ecruitmentCOLLEEN ALLEN, MPH, CCRATHE EMMES CORPORATIONTHE SOCIETY FOR CLINICAL TRIALS35 THANNUAL MEETING35 ANNUAL MEETINGMAY 19, 2014 PHILADELPHIA, PENNSYLVANIAB ackground Ideally, Eligibility criteria are not changed after recruitment begins Under certain circumstances, it is necessary to revise the criteriathe criteria The pros and cons, from a data management, regulatory, and statistical perspective, must be gy,pp,weighed Presentation draws on experiences and lessons ld dif i li ibilit it i ti iti ti learned Modifying Eligibility criteria post-initiation of recruitment for a large, multi-center protocol within a multi- Study clinical trials networkyNIDA CTN Clinical Trials Network (CTN) of the National ()Institute on Drug Abuse (NIDA) Multi-site, multi-pr
Background Ideally, eligibility criteria are not changed after recruitment begins Under certain circumstances, it is necessary to revise the criteria The pros and cons, from a data management, reggy, pp ,ulatory, and statistical perspective, must be weighed Presentation draws on experiences and lessons l d dif i li ibilit it i tlearned modifying eligibility criteria post-i iti ti initiation
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