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Investigator-led research • learning & preparation

Investigator-Initiated Trials

From a clinical question to a research discussion. Explore who does what, what to prepare and which questions to take to your institution.

Often abbreviated IIT, and sometimes called an investigator-sponsored study.

A question worth asking.

A plan that puts participants first.

Information is educational and does not replace medical advice. This is a planning aid—not a protocol, ethics approval, regulatory determination, funding application or authorization to recruit.

This guide is available in all six site languages. Linked outside sources may be in English only.

Research literacy

What is an IIT?

An investigator-initiated trial begins with a research question proposed by an investigator or academic team. The investigator may work with an institution, funder or other collaborators. The actual sponsor and responsibilities must be confirmed for the particular study.

A sponsor-investigator is an individual who both initiates and conducts the investigation. Not every investigator-led project uses that legal arrangement. The principal investigator (PI) leads the conduct of the study.

Source: NIH explanatory role definitions ↗ (background explanation, not current legal advice). See current registry policy ↗ and consult your institution.

Important distinction

Origin, sponsorship and funding are different

  • The person who proposes the question is not automatically the legal sponsor.
  • A university name, investigator name or non-industry sponsor label alone does not prove a study is an IIT.
  • External funding or product support does not, by itself, define who is responsible for the study.
  • The institution and study documentation—not this shell—confirm the arrangement.

Source: NIH responsible-party explanatory note ↗. Information is educational and does not replace medical advice.

Who should be in the discussion?

Orientation to responsibilities — confirm the actual allocation locally
Role / groupPlain-language purposeQuestion to ask
Investigator / PILeads the conduct of the research and the participant-facing study team.Who is accountable for the protocol, participant evaluation and research records?
Sponsor / sponsor-investigatorThe identified initiator or accountable sponsoring arrangement; may differ from the funder.Who accepts the applicable sponsor responsibilities?
Ethics committee / IRBIndependent review of the research and participant protections through the applicable local process.Which review and consent requirements apply here?
Institutional research officeHelps clarify institutional permissions, contracts and applicable obligations.Which specialists must confirm the regulatory and operational route?
Study coordinator and support teamSupport visits, records and communications under the study plan.Who handles day-to-day questions, safety escalation and secure communication?
Participant / caregiverCan ask questions and make an informed, voluntary choice about participation.What are the risks, possible benefits, alternatives and visit commitments?

Sources: ClinicalTrials.gov definitions ↗ · Patient information ↗. Information is educational and does not replace medical advice.

A discussion pathway, not a permission checklist

From question to shared learning

    Prepare a non-confidential discussion note

    Keep notes in this page for the current session, or download a text file for your own use.

    Do not enter patient identifiers, investigator contact details, confidential sponsor material or unpublished sensitive protocols. Nothing is submitted to a research office or study team. Reloading the page clears these notes.

    Discussion tracker

    “Discussed” is a personal note, not independent confirmation or approval. “Needs discussion” is not a failure decision.

    Planning prompts are a Bloom discussion aid, informed by registry protocol definitions ↗. No jurisdiction-specific compliance or approval decision is made. Information is educational and does not replace medical advice.

    Explore related public research

    Carry your disease and city into trial search. This does not restrict results to verified IITs.

    No query is sent until you press Search trials on the next page. Ask the listed study team who initiated the trial and which institution or person is the sponsor.

    Registration and reporting policy ↗ · Registry field definitions ↗

    Confirm action

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    Information is educational and does not replace medical advice. A picture does not diagnose a condition or demonstrate treatment effectiveness.