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Background: Thrombolytic therapy for acute ischemic stroke has been approached cautiously because there were high rates of intracerebral hemorrhage in early clinical trials. We performed a randomized,

How to fill out trial design and reporting

How to fill out trial design and reporting

1. Clearly define the research question or hypothesis that will be tested in the trial.
2. Determine the study design that will be used (e.g. randomized controlled trial, cohort study, case-control study).
3. Develop a detailed protocol outlining the study methods, procedures, and analysis plan.
4. Obtain ethical approval from an Institutional Review Board (IRB) or Ethics Committee.
5. Recruit participants according to the inclusion and exclusion criteria specified in the protocol.
6. Randomize participants to treatment groups if using a randomized design.
7. Collect data according to the study protocol.
8. Analyze the data using appropriate statistical methods.
9. Interpret the results and draw conclusions based on the findings.
10. Report the trial findings according to established reporting guidelines (e.g. CONSORT for randomized trials).

Who needs trial design and reporting?

1. Researchers conducting clinical trials or other types of research studies.
2. Funding agencies and sponsors who are supporting research projects.
3. Regulatory authorities who evaluate the safety and efficacy of new interventions.
4. Policy makers who use research findings to inform healthcare decisions.
5. Journal editors and peer reviewers who assess the quality and validity of study findings.

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What is trial design and reporting?

Trial design and reporting refers to the structured plan and subsequent documentation outlining the methodology, objectives, and outcomes of a clinical trial or experimental study. It ensures transparency and reproducibility of the research.

Who is required to file trial design and reporting?

Researchers, sponsors, or institutions conducting clinical trials are typically required to file trial design and reporting, ensuring that all relevant information is accessible to regulatory bodies and the public.

How to fill out trial design and reporting?

To fill out trial design and reporting, one must adhere to specific guidelines such as including study objectives, methodology, participant demographics, intervention details, and outcome measures, often utilizing templates provided by regulatory authorities.

What is the purpose of trial design and reporting?

The purpose of trial design and reporting is to provide a clear framework for conducting research, facilitate the evaluation of study results, promote accountability, and enhance the overall understanding and trust in clinical research.

What information must be reported on trial design and reporting?

The information that must be reported includes the study title, the rationale for the trial, design type, participant eligibility criteria, intervention details, outcome measures, statistical analysis plan, and any amendments made during the trial.