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Tranexamic acid for the treatment of gastrointestinal bleeding: an international randomised, double blind placebo controlled trialCLINICAL TRIAL PROTOCOL UK VERSIONProtocol Number: ISRCTN11225767

How to fill out clinical trial protocol

How to fill out clinical trial protocol

1. Start by sating the title of the clinical trial protocol.
2. Include the protocol number and version number for proper identification.
3. Provide a brief summary or abstract of the study, including the purpose, rationale, and objectives.
4. Detail the study design, including the type of study, study population, and any interventions being tested.
5. Clearly outline the inclusion and exclusion criteria for participants.
6. Describe the methods for participant recruitment, enrollment, and follow-up.
7. Include details on data collection procedures, study assessments, and monitoring.
8. Explain the statistical methods that will be used for data analysis.
9. Discuss the potential risks and benefits of participating in the study.
10. Provide information on how to handle adverse events and ensure participant safety.

Who needs clinical trial protocol?

1. Researchers conducting clinical trials.
2. Regulatory authorities overseeing drug development.
3. Ethics committees reviewing study protocols.
4. Sponsors funding the research.
5. Investigators and study coordinators involved in the trial.

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What is clinical trial protocol?

A clinical trial protocol is a document that outlines the plan for a clinical trial, describing the study design, objectives, methodology, statistical considerations, and organization of the trial.

Who is required to file clinical trial protocol?

The sponsor of the clinical trial, which can be a pharmaceutical company, academic institution, or research organization, is required to file the clinical trial protocol.

How to fill out clinical trial protocol?

To fill out a clinical trial protocol, one must define the study objectives, design, participant criteria, treatment regimens, data collection methods, and statistical analysis plans, among other details.

What is the purpose of clinical trial protocol?

The purpose of a clinical trial protocol is to provide a detailed plan that ensures the trial is conducted ethically and scientifically, and that the results can be trusted and reproduced.

What information must be reported on clinical trial protocol?

The clinical trial protocol must report information such as study objectives, methods, participant eligibility criteria, treatment plans, outcome measures, and data analysis strategies.