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Clinical Study Design, Protocol and Informed Consent Form Development Benny For Clinical Research Management Office 5th May, 20161Will cover: Basic clinical study design Essential components of a

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What is clinical study design protocol?

A clinical study design protocol is a detailed plan outlining how a clinical trial will be conducted, including the objectives, methodology, and statistical analysis.

Who is required to file clinical study design protocol?

The principal investigator or sponsor of the clinical trial is usually required to file the clinical study design protocol.

How to fill out clinical study design protocol?

To fill out a clinical study design protocol, the investigator must provide detailed information on the study objectives, methodology, participant inclusion/exclusion criteria, and statistical analysis plan.

What is the purpose of clinical study design protocol?

The purpose of a clinical study design protocol is to ensure that the trial is conducted in a systematic and ethical manner, with clear objectives and methods.

What information must be reported on clinical study design protocol?

A clinical study design protocol must include information on study objectives, methodology, participant characteristics, statistical analysis plan, and potential risks and benefits.

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