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Investigator Initiated Trials Contract and Budget Process Initiation Checklist PI Name: PI Division:Division Chief: Division Chief Approval/Meeting Date: TYPE OF STUDY (select one) Drug Registry Tissue

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What is investigator initiated trials?

Investigator initiated trials are clinical trials where the researchers or investigators themselves are responsible for the design, conduct, and funding of the study.

Who is required to file investigator initiated trials?

Researchers or investigators who are conducting the trials are required to file investigator initiated trials.

How to fill out investigator initiated trials?

Investigators can fill out investigator initiated trials by providing detailed information on the study design, objectives, methodology, and funding sources.

What is the purpose of investigator initiated trials?

The purpose of investigator initiated trials is to explore new treatments, interventions, or diagnostic techniques to improve patient care.

What information must be reported on investigator initiated trials?

Investigators must report on the study protocol, informed consent process, adverse events, data analysis plan, and funding sources.

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