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ORA: 23080302IRB01 Date IRB Approved: 8/11/2023 Expiration Date: 8/11/2024 Amendment Date: 1/9/2024CONSENT/AUTHORIZATION FOR PARTICIPATION IN A RESEARCH STUDY Principal Investigator:Brad Appellant,
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01
Gather all necessary information and forms required for the phase III randomized trial.
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Ensure that all trial participants meet the eligibility criteria set forth in the study protocol.
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Randomly assign eligible participants to either the experimental group or the control group.
04
Administer the intervention or treatment to the experimental group as outlined in the study protocol.
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Monitor and track the progress of all participants throughout the trial.
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Collect and analyze data according to the pre-established statistical analysis plan.
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Draw conclusions based on the results of the trial and report any findings in a scientific publication or presentation.

Who needs a phase iii randomized?

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Researchers and scientists conducting clinical trials to evaluate the efficacy and safety of new drugs or treatments.
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Pharmaceutical companies seeking regulatory approval for a new drug or medical device.
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Regulatory agencies such as the FDA or EMA that require evidence from phase III randomized trials to assess the benefit-risk profile of a new intervention.
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Phase III randomized refers to a stage in drug development where a new treatment is tested in a larger group of patients in a randomized manner to compare its effectiveness and safety against a standard treatment or placebo.
Sponsors of clinical trials, typically pharmaceutical or biotechnology companies, are required to file a phase III randomized study as part of the regulatory submission process to demonstrate the efficacy and safety of their investigational product.
Filling out a phase III randomized study involves providing detailed information about the study design, objectives, methodology, participant demographics, endpoints, and data collection processes, following guidelines set by regulatory agencies.
The purpose of a phase III randomized study is to provide definitive evidence on a treatment's effectiveness, monitor side effects, and compare the new treatment's benefits and risks against standard care.
Information that must be reported includes study design, participant characteristics, treatment allocation, outcome measures, statistical analysis methods, and results including efficacy and safety data.
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