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EXTRACT Number: 202000133126IRAS Ref: 281919PROLIFIC Chemoprophylaxis For COVID-19 infectious disease (the PROLIFIC trial)___ Trial Title:Chemoprophylaxis For COVID-19 Infectious DiseaseProtocol Number:PROLIFIC2020EudraCT

How to fill out controlled double-blind randomized trial

How to fill out controlled double-blind randomized trial

1. Determine the research question and hypothesis to be testing in the trial.
2. Define the study population and inclusion/exclusion criteria.
3. Randomly assign participants to either the control group or the experimental group.
4. Ensure that neither the participants nor the researchers know which group each participant is in (double-blind).
5. Administer the intervention or treatment to the experimental group while the control group receives a placebo or standard treatment.
6. Collect data on the outcomes of interest in a standardized manner.
7. Analyze the data using appropriate statistical methods to determine if there is a significant difference between the two groups.

Who needs controlled double-blind randomized trial?

1. Researchers conducting clinical trials for new drugs or medical treatments.
2. Regulatory agencies evaluating the safety and efficacy of new products.
3. Healthcare providers making decisions about the best treatment options for their patients.

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What is controlled double-blind randomized trial?

A controlled double-blind randomized trial is a research study where neither the participants nor the researchers know who is receiving the treatment and who is receiving a placebo or standard treatment. This helps to minimize bias and accurately evaluate the effectiveness of a new intervention.

Who is required to file controlled double-blind randomized trial?

Researchers conducting clinical trials involving new interventions or treatments are required to file controlled double-blind randomized trials to regulatory authorities for approval and oversight.

How to fill out controlled double-blind randomized trial?

Controlled double-blind randomized trials are typically filled out with detailed information on study design, participant selection, interventions, outcomes, data analysis, and ethical considerations. Researchers must follow strict guidelines to ensure the validity and reliability of the trial results.

What is the purpose of controlled double-blind randomized trial?

The purpose of a controlled double-blind randomized trial is to determine the efficacy and safety of a new intervention or treatment by comparing it to a placebo or standard treatment. This helps to establish evidence-based practices in healthcare.

What information must be reported on controlled double-blind randomized trial?

Information reported on a controlled double-blind randomized trial typically includes study objectives, methods, participant demographics, intervention details, outcomes, adverse events, analysis plan, and conclusions.