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Comprehensive Cardiac Rehabilitation Feasibility After Stroke CCR FAST IRB: A18361 NCT: 03944668 Clinical Study Protocol Amendment 2 Date: 25 September 2020 Sponsor Regions Hospital Medical Staff

How to fill out a double-blind placebo-controlled pilot

How to fill out a double-blind placebo-controlled pilot

1. Start by defining the research objectives and hypothesis for the pilot study.
2. Obtain the necessary approvals and permissions from the appropriate ethics committee or review board.
3. Develop a detailed protocol outlining the study design, inclusion/exclusion criteria, treatment/placebo administration, and data collection methods.
4. Recruit eligible participants who meet the inclusion criteria and obtain informed consent from them.
5. Randomly assign the participants to either the treatment or placebo group.
6. Ensure that both the researchers and the participants are unaware of the group assignments (double-blind).
7. Administer the treatment and placebo in a blinded manner.
8. Collect and record the relevant data as per the study protocol.
9. Analyze the data using appropriate statistical methods.
10. Evaluate the results and draw conclusions based on the findings.
11. Prepare a report or manuscript summarizing the pilot study.
12. Share the findings with the scientific community through publication or presentation.

Who needs a double-blind placebo-controlled pilot?

1. Researchers who want to assess the safety, feasibility, and initial effectiveness of a new intervention or treatment approach often need a double-blind placebo-controlled pilot.
2. Pharmaceutical companies conducting early-phase clinical trials may also require a double-blind placebo-controlled pilot to gather preliminary data on the safety and potential efficacy of a new drug.
3. Regulatory bodies may require double-blind placebo-controlled pilots as part of the approval process for new medications or medical devices.
4. Scientists conducting research in fields such as psychology, nutrition, or alternative medicine may use this study design to gather evidence on the effectiveness of their interventions.
5. Any researcher aiming to minimize bias and increase the reliability of their study results would benefit from using a double-blind placebo-controlled pilot.

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What is a double-blind placebo-controlled pilot?

A double-blind placebo-controlled pilot is a type of clinical trial where neither the participants nor the researchers know who is receiving the actual treatment and who is receiving a placebo.

Who is required to file a double-blind placebo-controlled pilot?

Researchers conducting a clinical trial involving a double-blind placebo-controlled pilot are required to file the necessary documentation with the appropriate regulatory authorities.

How to fill out a double-blind placebo-controlled pilot?

To fill out a double-blind placebo-controlled pilot, researchers must accurately record and report all relevant data, including the administration of the treatment and placebo, any observed effects, and other pertinent information.

What is the purpose of a double-blind placebo-controlled pilot?

The purpose of a double-blind placebo-controlled pilot is to evaluate the safety and effectiveness of a new treatment in a controlled setting, while minimizing bias and maximizing the reliability of the results.

What information must be reported on a double-blind placebo-controlled pilot?

Information that must be reported on a double-blind placebo-controlled pilot includes details on the study design, participant demographics, treatment administration, adverse events, and the results of the trial.