Get the free B1871047 Non-interventional Study Protocol

This document outlines the protocol for a non-interventional, observational study evaluating the efficacy and safety of Bosulif® () in patients with chronic myeloid leukaemia (CML) who are resistant or intolerant to prior therapies with tyrosine kinase inhibitors (TKI). The study aims to collect data on safety, efficacy, and treatment modalities under real-world conditions across various centers in France.

How to fill out b1871047 non-interventional study protocol

How to fill out b1871047 non-interventional study protocol

1. Begin with the title page, providing the study title, protocol number (B1871047), and the dates of preparation.
2. Fill out the introduction section with the background information about the study and its objectives.
3. Outline the study design, detailing whether it is observational or retrospective, and describe the participant selection criteria.
4. Specify the primary and secondary endpoints of the study, clearly defining how they will be measured.
5. Include details regarding data collection methods, including questionnaires, interviews, or medical records.
6. Provide a clear description of the statistical analysis plan, including sample size calculation and methods for data analysis.
7. Outline the ethical considerations, emphasizing informed consent and data confidentiality.
8. Attach any relevant appendices, such as data collection tools or informed consent forms.

Who needs b1871047 non-interventional study protocol?

1. Researchers conducting non-interventional studies.
2. Ethics review boards reviewing study protocols.
3. Regulatory authorities overseeing compliance in clinical research.
4. Study sponsors or funding organizations requiring protocol documentation.

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What is b1871047 non-interventional study protocol?

The b1871047 non-interventional study protocol is a document that outlines the plan for conducting a non-interventional study, focusing on observational data collection to assess the effectiveness of a treatment or intervention without influencing the participant's care.

Who is required to file b1871047 non-interventional study protocol?

Researchers or institutions conducting non-interventional studies are required to file the b1871047 non-interventional study protocol.

How to fill out b1871047 non-interventional study protocol?

To fill out the b1871047 non-interventional study protocol, researchers should provide detailed information about the study design, objectives, participant criteria, data collection methods, and any ethical considerations.

What is the purpose of b1871047 non-interventional study protocol?

The purpose of the b1871047 non-interventional study protocol is to ensure that the study is conducted ethically, scientifically valid, and adheres to regulatory requirements while collecting data that can inform healthcare practices.

What information must be reported on b1871047 non-interventional study protocol?

The information that must be reported includes the study objectives, methodology, participant demographics, data analysis plan, and any potential conflicts of interest.