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Expanded Access Study Protocol Version
Definition 1
An action plan of a pre-clinical or clinical study describing the procedure for obtaining an experimental drug or device for patients who are not adequately treated by existing therapy, who do not meet eligibility criteria for enrollment, or who are otherwise unable to participate in a controlled clinical study. (NCI Thesaurus)
Definition 2
An action plan of a pre-clinical or clinical study describing the procedure for obtaining an experimental drug or device for patients who are not adequately treated by existing therapy, who do not meet eligibility criteria for enrollment, or who are otherwise unable to participate in a controlled clinical study. NOTE(S): This type of study is used to register all types of non-protocol access to experimental treatments, including protocol exception, single-patient IND, treatment IND, compassionate use, emergency use, continued access and parallel track. (Parallel track means there is separate group of subjects that go through the same protocol activities but that didn't get on the main trial due to different reasons such as eligibility criteria, location, etc. and their outcome data is collected and analyzed, just not analyzed with the other data, rather in parallel.) (NCI Thesaurus/BRIDG)
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