Get the free Investigator Initiated Trial Concept Form - Mylan

Investigator Initiated Trial Concept Former Page 1 of 2 Form Version: 20May2018Complete as many fields as possible Submitted by (Name): Date Submitted: 1. Request Type: (Check all that apply)dd/mm/YYY

How to fill out investigator initiated trial concept

How to fill out investigator initiated trial concept

1. Determine the research question or objective of the trial.
2. Develop a research protocol, including study design, sample size calculation, and inclusion/exclusion criteria.
3. Prepare an Investigator Brochure, which provides detailed information about the investigational product.
4. Obtain necessary approvals from ethics committees and regulatory authorities.
5. Identify potential investigators who have the expertise and resources to conduct the trial.
6. Negotiate agreements with the investigators, ensuring clarity on roles, responsibilities, and financial arrangements.
7. Conduct a pilot study, if required, to assess the feasibility and refine the protocol.
8. Recruit eligible participants and obtain informed consent.
9. Implement the trial according to the study protocol, including data collection, site monitoring, and quality assurance.
10. Analyze the collected data, interpret the results, and draw conclusions.
11. Prepare and submit a final report detailing the findings, conclusions, and any recommendations.
12. Consider publishing the results in a scientific journal to contribute to the knowledge in the field.

Who needs investigator initiated trial concept?

1. Investigators conducting clinical research
2. Pharmaceutical companies
3. Academic institutions
4. Medical research organizations
5. Healthcare professionals interested in exploring new treatments or interventions
6. Government agencies involved in healthcare policy and decision-making

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What is investigator initiated trial concept?

Investigator initiated trial concept refers to a clinical trial in which the investigator takes the lead role in designing, conducting, and funding the study.

Who is required to file investigator initiated trial concept?

Investigators or research teams who are looking to conduct a clinical trial are required to file investigator initiated trial concept.

How to fill out investigator initiated trial concept?

Investigators can fill out investigator initiated trial concept by providing detailed information about the study design, objectives, methodology, funding sources, and potential risks and benefits.

What is the purpose of investigator initiated trial concept?

The purpose of investigator initiated trial concept is to allow investigators to explore new research ideas and contribute to the scientific community by conducting independent studies.

What information must be reported on investigator initiated trial concept?

Investigators must report information such as study objectives, inclusion criteria, exclusion criteria, study endpoints, data analysis plan, and ethical considerations.