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Master Statistical Analysis Plan for the PRACTICAL Platform Prepared using Gamble et al. (2017) Guidelines for the Content of Statistical Analysis Plans in Clinical Trials, JAVA. 2017;318(23):23372343.

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What is early phase clinical trials?

Early phase clinical trials are studies conducted to assess the safety and effectiveness of a new medical intervention in a small group of people for the first time.

Who is required to file early phase clinical trials?

Researchers or sponsors conducting the clinical trials are required to file them with the appropriate regulatory bodies.

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Early phase clinical trials can be filled out using the required forms provided by the regulatory authorities along with necessary documentation.

What is the purpose of early phase clinical trials?

The purpose of early phase clinical trials is to evaluate the safety profile and initial efficacy of a new medical intervention.

What information must be reported on early phase clinical trials?

Information such as study protocol, informed consent forms, study population characteristics, adverse events, and results must be reported on early phase clinical trials.

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