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Study Protocol Version Phase Code
Definition 1
A coded value specifying the designation of approval phase for a study. (NCI Thesaurus)
Definition 2
A coded value specifying the designation of approval phase for a study. EXAMPLE(S): I, I/II, II, III, N/A. NOTE(S): Studies are generally categorized into four (sometimes five) phases described separately herein. An investigational medicine or product may be evaluated in two or more phases simultaneously in different studies, and some studies may overlap two different phases. Phase 1: The initial introduction of an investigational new drug into humans. Phase 1 studies are typically closely monitored and may be conducted in patients or normal volunteer subjects. Phase 2: Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. Phase 3: Studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. Phase 3b: Phase 3b studies are a sub category of phase 3 trials near the time of approval to elicit additional findings. Phase 4: Concurrent with marketing approval, Food and Drug Administration (FDA) may seek agreement from the sponsor to conduct certain post-marketing (phase 4) studies to delineate additional information about the drug's risks, benefits, and optimal use. Phase 5: Post-marketing surveillance is sometimes referred to as Phase 5. (NCI Thesaurus/BRIDG)
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