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Study ID:IRB201401056 Date Approved: 2/23/2023 1&7INFORMED CONSENT FORM to Participate in Research, andAUTHORIZATION to Collect, Use, and Disclose Protected Health Information (PHI)INTRODUCTION 1DPHRISHUVRQVHHNLQJRXUFRQVHQW
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What is a phase 3b single?
A phase 3b single is a specific filing requirement related to clinical trial phases that typically involves the collection and reporting of data for a given study or drug development process.
Who is required to file a phase 3b single?
Pharmaceutical companies or sponsors conducting clinical trials that fall under phase 3b guidelines are required to file a phase 3b single.
How to fill out a phase 3b single?
To fill out a phase 3b single, follow the specific guidelines provided by regulatory authorities which usually include gathering and entering data related to trial outcomes, participant demographics, and safety information.
What is the purpose of a phase 3b single?
The purpose of a phase 3b single is to collect comprehensive data on the effectiveness and safety of a drug post-approval, often in a real-world setting.
What information must be reported on a phase 3b single?
Information that must be reported includes study design, participant demographics, adverse events, and outcomes related to the drug's efficacy and safety.
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