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INVESTIGATOR INITIATED TRIALGUIDEBOOKV1: 5/30/2024What is an Investigator Initiated Trial? An Investigator Initiated trial (IIT) is a clinical trial in which the investigator conceives the research,

How to fill out investigator initiated trial

How to fill out investigator initiated trial

1. Identify the research question and objectives clearly.
2. Develop a detailed study protocol outlining methodology, participant criteria, and statistical analysis.
3. Ensure compliance with institutional and regulatory guidelines including ethical considerations.
4. Prepare necessary documentation for ethics review and regulatory approvals.
5. Recruit and consent participants following the approved protocol.
6. Collect and manage data according to the specified methodologies and standards.
7. Analyze data using appropriate statistical methods.
8. Prepare study results for publication and dissemination.

Who needs investigator initiated trial?

1. Clinical researchers pursuing novel questions not funded by pharmaceutical companies.
2. Investigators affiliated with academic institutions seeking to advance knowledge in their field.
3. Healthcare providers interested in addressing specific patient care issues through clinical trials.
4. Organizations aiming to explore new treatment options or interventions.

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What is investigator initiated trial?

An investigator initiated trial (IIT) is a clinical study that is initiated and managed by a researcher or investigator rather than a pharmaceutical company or sponsor. The investigator is responsible for the study design, conduct, and reporting of results.

Who is required to file investigator initiated trial?

Investigators or researchers who initiate and conduct their own clinical trials are required to file for investigator initiated trials. This includes those affiliated with academic institutions, hospitals, or other research organizations.

How to fill out investigator initiated trial?

To fill out an investigator initiated trial, the investigator must complete a submission form that includes information about the study design, objectives, methods, patient population, and ethical considerations. This may involve submitting documents to an Institutional Review Board (IRB) or regulatory body.

What is the purpose of investigator initiated trial?

The purpose of an investigator initiated trial is to evaluate new treatment methods, investigate hypotheses, or explore unproven treatment protocols based on the investigator's interest or observations, often to fill knowledge gaps in existing literature.

What information must be reported on investigator initiated trial?

Information that must be reported includes trial design, eligibility criteria, treatment regimens, outcomes, safety data, and results of the study. Additionally, any adverse events or serious issues that occur during the trial must also be reported.