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An Open-label, Randomized, Two-way Crossover, Bioequivalence Study in Healthy Volunteers to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib. This protocol amendment outlines the methodology, objectives, study design, and safety considerations for the clinical investigation.
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What is protocol amendment 2?
Protocol amendment 2 is a formal modification to an existing study protocol that outlines changes or additional information necessary to refine the conduct of the study.
Who is required to file protocol amendment 2?
The principal investigator or sponsor of the study is typically required to file protocol amendment 2 with the relevant regulatory authorities.
How to fill out protocol amendment 2?
To fill out protocol amendment 2, follow the format provided by the regulatory authority, including sections for the changes, rationale for amendments, and any relevant new data or findings.
What is the purpose of protocol amendment 2?
The purpose of protocol amendment 2 is to ensure the study remains aligned with its objectives, comply with regulatory requirements, and improve the accuracy and safety of the research.
What information must be reported on protocol amendment 2?
Protocol amendment 2 must report details of the changes being made, their justification, any impacts on the study timeline, and updates to participant consent documents, if applicable.
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