August 2024 SOCRA Source Journal - Journal - Page 25
JOURNAL ARTICLES
Investigator-Initiated
Research from
Start to “Audit”
Erica M. Weidler, MEd, MA, CCRC
Research Associate and Assistant Professor,
Phoenix Children’s
Erica M. Weidler, MEd, MA, CCRC
Abstract: Investigator-initiated research is very different than traditional research sponsored by a pharmaceutical or
device company. This article describes the process for protocol development and launch of an investigator-initiated
trial and the role of a sponsor-investigator. The perspective of a sponsor-investigator during an inspection by the U.S.
Food and Drug Administration is covered, along with the experience of working on a 100% electronic study for a 14site National Institutes of Health U-grant project.
Disclosures: The author has no disclosures or 昀椀nancial con昀氀icts of interests.
Introduction
Traditionally, drug and device
studies have a pharmaceutical
or device manufacturer who
acts as the study sponsor.
The pharmaceutical or
manufacturer sponsor initiates
and takes responsibility for
the clinical trial and engages
with an investigator, typically
a physician, who conducts the
study. The sponsor has ultimate
control over what is studied and
how. However, not all research
takes this traditional pathway.
Investigator-initiated research
(IIR), also called investigatorinitiated trials (IIT), has an
investigator, or group of
investigators, most commonly
af昀椀liated with an academic
institution, who initiates the trial,
conducts the research and takes
sole responsibility for the clinical
trial. This type of research usually
involves a highly specialized
investigator who wants to
answer a research question
without a pharmaceutical or
device sponsor. As such, IIR
expands current knowledge
predicated on the investigator’s
clinical interest.
A research team’s experience
with a National Institutes of
Health (NIH)-funded clinical trial
and Investigational New Drug
application will be described
in this article as well as the
experience of managing a 14site NIH U grant that is 100%
electronic. A delegation log with
wet ink signatures is the only
paper document maintained.
Responsibilities of the
Sponsor-Investigator
According to the Code of
Federal Regulations (CFR), a
sponsor is “a person who takes
responsibility for and initiates
a clinical investigation. The
sponsor may be an individual
or pharmaceutical company,
governmental agency, academic
institution, private organization,
or other organization. The
sponsor does not actually
conduct the investigation
unless the sponsor is a sponsorinvestigator” (21 CFR 312.3b).
An investigator is “an individual
who actually conducts a clinical
investigation (i.e., under whose
immediate direction the drug
is administered or dispensed
to a subject)” (21CFR312.3b).
A sponsor-investigator (SI)
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