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Meeting: Board of Managers
Meeting date: 11/4/2021
Agenda Item #: 11.2
Request for Board Action
Title:
Resolution number:Approval of Phase II Design Contract for 325 Blake Road Restoration and
Redevelopment
21075Prepared
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Who needs approval of phase ii?
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Individuals or departments who are seeking approval to move forward with phase II of a project or study.
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What is approval of phase ii?
Approval of phase II refers to the regulatory approval process that permits a sponsor to begin clinical trials designed to test the efficacy and safety of a drug or treatment in a larger population after initial safety has been established in phase I.
Who is required to file approval of phase ii?
Typically, the sponsor of the clinical trial, which can be a pharmaceutical company, research institution, or academic organization, is required to file for approval of phase II studies with the relevant regulatory authority.
How to fill out approval of phase ii?
To fill out approval of phase II, the sponsor must complete the required application forms provided by the regulatory body, including detailed information about the study design, methodology, statistical analyses, and previous clinical results.
What is the purpose of approval of phase ii?
The purpose of phase II approval is to determine the efficacy of a drug or treatment in patients who have the condition it aims to treat, while also further assessing its safety in a larger group.
What information must be reported on approval of phase ii?
Information that must be reported includes study objectives, design, methodology, patient population, dosage and administration, safety data from phase I trials, and statistical analysis plans.
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