Investigator-Initiated Trial
A clinical trial where an individual investigator (typically academic), not the device or drug manufacturer, holds the regulatory sponsor role and is responsible for IRB, IDE/IND, and conduct.
Definition
An Investigator-Initiated Trial (IIT) is a clinical study in which an individual investigator (almost always an academic clinician) acts as the regulatory sponsor under 21 CFR 312 (drug IND) or 812 (device IDE), holding all sponsor obligations for protocol design, IRB/IEC submission, regulatory submissions, AE reporting, and study conduct. Industry support is typically limited to product supply and a financial grant under an Investigator-Initiated Research (IIR) agreement.What this means in practice
IITs are an important evidence-generation channel for new use cases, expanded populations, and combination studies that the manufacturer is unlikely to fund directly. Compliance landmines arise when industry inadvertently exerts study-design control, which can convert the study into a manufacturer-sponsored trial with full PMA/labeling implications.- •Industry sponsors providing too much protocol input, risks reclassification of the study as manufacturer-sponsored.
- •Investigator-sponsors underestimating the regulatory burden they have assumed.
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsInternational standard for the design, conduct, and reporting of clinical trials.
Voluntary, informed agreement to participate in research after disclosure of risks and benefits.
Board that reviews and approves human-subjects research at an institution.
FDA authorization to use an investigational device in a clinical study.
More in Clinical & Trials
· Same categoryTrial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data.
Any untoward medical occurrence in a subject, whether or not related to the device.
Data integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate (plus Complete, Consistent, Enduring, Available).
An IVD's ability to detect small quantities of an analyte.
Primary references
3 sources- 1
FDA, Investigator ResponsibilitiesVerifiedFDAfda.gov
- 2
21 CFR 312, Investigational New Drug ApplicationVerifiedeCFRecfr.gov
- 3
ClinicalTrials.govVerifiedNIHclinicaltrials.gov
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