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IRB: 161047-Page 1 of 10INFORMED CONSENT DOCUMENT Phase II study of TAK228 (MLN0128) in soft tissue sarcomas with dysregulation of the motor pathway Supported by: Millennium Pharmaceuticals, Inc.
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What is phase ii study of?
Phase II study is a clinical research study that evaluates the effectiveness of a new treatment in a larger group of people.
Who is required to file phase ii study of?
The pharmaceutical company or research organization conducting the study is required to file the Phase II study.
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Phase II study is typically filled out by the principal investigator or study coordinator involved in the research.
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The purpose of Phase II study is to gather more information about the safety and effectiveness of the new treatment.
What information must be reported on phase ii study of?
Phase II study must report data on patient demographics, treatment protocol, study outcomes, and any adverse events.
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