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Page 1 of 42 CLINICAL STUDY PROTOCOL Randomized, double-blind phase II study to compare plus oral plus with oral plus alone in patients with stage AIIB/IV nonsmall cell lung cancer (NS CLC) Short
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What is clinical study protocol?
A clinical study protocol is a document that outlines the objectives, design, methodology, and statistical considerations of a clinical trial or study.
Who is required to file clinical study protocol?
The principal investigator, sponsor, or responsible party of the clinical study is required to file the clinical study protocol.
How to fill out clinical study protocol?
Filling out a clinical study protocol involves providing detailed information about the study's background, objectives, methodology, participant eligibility criteria, data collection and analysis plans, and potential risks and benefits. It is typically filled out using a standardized template.
What is the purpose of clinical study protocol?
The purpose of a clinical study protocol is to provide a comprehensive plan for conducting a study, ensuring the safety and welfare of participants, generating reliable data, and guiding the actions of the study team.
What information must be reported on clinical study protocol?
The clinical study protocol must include information such as the study's title, background, objectives, study design, participant eligibility criteria, treatment interventions, data collection and analysis plans, statistical considerations, adverse event reporting procedures, and ethical considerations.
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