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Investigator Sponsored Trial Application Form Form MA_DIR_00238FA (3.0) Contact: Research.Grants@Lantheus.com Phone: (800) 2234051 Fax: (978) 4367506Internal use only Clinical Grant Number: Date Received:___

How to fill out investigator sponsored trial application

How to fill out investigator sponsored trial application

1. To fill out an investigator sponsored trial application, follow these steps:
2. Start by reading the guidelines and instructions provided by the organization or institution sponsoring the trial.
3. Gather all the necessary information and documentation that will be required in the application process.
4. Begin the application by providing basic details such as the title of the trial, the principal investigator's name and contact information, and the trial location.
5. Clearly explain the background and rationale for the trial, including any supporting research or literature.
6. Describe the trial objectives, study design, and methodology in detail.
7. Provide information about the study population, including eligibility criteria and recruitment strategies.
8. Outline the interventions or treatments that will be employed in the trial and any associated risks or benefits.
9. Describe the data collection and analysis plan, including any statistical methods that will be used.
10. Address ethical considerations and provide information on how participant confidentiality will be maintained.
11. Include a detailed budget plan and any funding sources for the trial.
12. Complete any additional sections or forms required by the organization or institution.
13. Proofread and review the application for any errors or missing information before submitting.
14. Submit the application according to the specified submission process and timeline.
15. Follow up with the organization or institution to ensure the application has been received and to inquire about any additional steps or requirements.

Who needs investigator sponsored trial application?

1. Investigator sponsored trial applications are needed by researchers, medical professionals, or institutions that want to conduct clinical trials or research studies.
2. These applications are typically required by funding organizations, research institutions, or regulatory bodies to ensure that the trial meets the necessary criteria and ethical standards.
3. The application process helps to evaluate the feasibility, scientific validity, and ethical considerations of the proposed trial.

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What is investigator sponsored trial application?

An investigator sponsored trial application is a submission made by a researcher or investigator to regulatory authorities to seek approval for a clinical trial that they intend to conduct independently, rather than being sponsored by a pharmaceutical or biotech company.

Who is required to file investigator sponsored trial application?

Typically, researchers or investigators who are leading a clinical trial in which they are the principal investigator and who have initiated the study independently are required to file an investigator sponsored trial application.

How to fill out investigator sponsored trial application?

To fill out an investigator sponsored trial application, you should carefully follow the guidelines provided by the regulatory authority, provide all required information including study details, objectives, methodology, and any necessary documentation, and ensure compliance with ethical and safety standards.

What is the purpose of investigator sponsored trial application?

The purpose of an investigator sponsored trial application is to seek regulatory approval for a clinical trial, ensuring that the study meets legal and ethical standards and is conducted safely.

What information must be reported on investigator sponsored trial application?

Key information required includes the study protocol, rationale for the study, details of the investigational product, study population, informed consent process, and safety monitoring plans.