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Final Report Phase II Evaluation of Rocas CBT CurriculumMay 31, 2021 Submitted to: Lili Elkins Roca, Inc. Submitted by: Abt Associates 10 Fawcett Street Cambridge, MA 02138Abt AssociatesReport TitleInsert
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What is phase ii evaluation of?
Phase II evaluation is primarily focused on assessing the efficacy and further evaluating the safety of a drug or intervention in a larger group of participants.
Who is required to file phase ii evaluation of?
Researchers and sponsors conducting clinical trials that progress beyond Phase I testing are required to file a Phase II evaluation.
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To fill out a Phase II evaluation, the researcher must complete the necessary regulatory forms, provide detailed data on the study design, participant demographics, and preliminary efficacy and safety results.
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The purpose of Phase II evaluation is to determine whether a treatment shows promise in treating a specific condition, as well as to gather more information on its safety and optimal dosage.
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The information required includes trial design, patient demographics, dosage levels, outcome measures, adverse events, and preliminary analysis of effectiveness.
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