Get the free Investigator Initiated Study Application Form

Title:Investigator Initiated Study Application Form Document No:DCR:FQA00065aRev:01933BPage:1 of 2Principal Investigator (PI) Investigator(s) Study Coordinator Has the PI conducted clinical studies

How to fill out investigator initiated study application

How to fill out investigator initiated study application

1. Begin by identifying the funding source for the study.
2. Develop a study protocol outlining the research question, study design, methodology, and data analysis plan.
3. Obtain approval from an Institutional Review Board (IRB) for the study protocol.
4. Create a budget detailing expenses for the study and justification for each expense.
5. Complete the application form provided by the funding source, ensuring all required information is included.
6. Submit the completed application along with any supporting documents to the funding source by the specified deadline.
7. Await notification from the funding source regarding the status of the application.

Who needs investigator initiated study application?

1. Investigators who are interested in conducting their own research studies
2. Researchers looking to secure funding for their research projects
3. Academic institutions and organizations seeking to support independent research initiatives

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What is investigator initiated study application?

An investigator initiated study application is a proposal for a research study that is initiated and conducted by a researcher, rather than a pharmaceutical or device company.

Who is required to file investigator initiated study application?

Researchers or investigators who wish to conduct clinical trials or studies using investigational drugs, devices, or biological products must file an investigator initiated study application.

How to fill out investigator initiated study application?

To fill out an investigator initiated study application, researchers should provide detailed information about their study design, objectives, methodology, participant recruitment strategies, and safety monitoring plans.

What is the purpose of investigator initiated study application?

The purpose of the investigator initiated study application is to obtain regulatory approval to conduct research that explores new uses for existing treatments or investigates new approaches to health interventions.

What information must be reported on investigator initiated study application?

The information reported must include the study title, objectives, methodology, participant demographics, potential risks and benefits, funding sources, and data management plans.