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Protocol Study ID: NN80224246 UTC: U111111853276 EU PAS No.:CONFIDENTIAL Confidentiality: Version: Status: Page:23 November 2015 5.0 Final 1 of 45Novo NordiskProtocolStudy ID: NN80224246 In market

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Define the research question and objectives of the trial

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Determine the study population and eligibility criteria

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Randomly assign participants to treatment and control groups

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What is a randomized controlled trial?

A randomized controlled trial (RCT) is a study design used to test the efficacy of an intervention by randomly assigning participants to either the intervention group or the control group, allowing for a comparison of outcomes.

Who is required to file a randomized controlled trial?

Researchers and institutions conducting clinical trials are typically required to register and file randomized controlled trials to ensure compliance with regulatory standards.

How to fill out a randomized controlled trial?

To fill out a randomized controlled trial, researchers must complete a registration form detailing the study's objectives, methodology, inclusion/exclusion criteria, and plans for data analysis, often using established clinical trial registries.

What is the purpose of a randomized controlled trial?

The purpose of an RCT is to eliminate bias and establish a cause-effect relationship between an intervention and its outcomes, providing reliable data on the efficacy and safety of the treatment being tested.

What information must be reported on a randomized controlled trial?

Information that must be reported includes the trial title, study design, eligibility criteria, interventions assigned, outcome measures, statistical analysis plans, and any other relevant data.

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