August 2024 SOCRA Source Journal - Journal - Page 26
is de昀椀ned as “an individual
who initiates and conducts
an investigation, and under
whose immediate direction
the investigational drug is
administered or dispensed” (21
CFR 312.3b).
As such, the SI must follow
the regulations for clinical
investigators and sponsors
(Table 1). As such, the SI must
consider the federal regulations
(21 CFR 312.50 & 21 CFR
312.60) and the International
Council on Harmonization of
Technical Requirements for
Registration of Pharmaceuticals
for Human Use (ICH)
TABLE 1
Responsibilities of the Sponsor-Investigator
•
Federal regulations:
o 21 CFR 312.50
o 21 CFR 312.60
•
Investigator Responsibilities in ICH GCP E6:
o 4.1 Investigator Quali昀椀cations; 4.6 Investigational Products
o 4.7 Randomization Procedures and Unblinding
o 4.6.3 Maintain Records
o 4.6.4 Investigational Product storage
o 4.6.5 Investigational Product usage
•
Sponsor responsibilities in ICH GCP E6:
o 5.12 Information on Investigational Product(s)
o 5.13 Manufacturing, Packaging, Labeling, and Coding
Investigational Product
o 5.15 Record Access
o 5.14 Supplying and Handling Investigational Product
o 5.16 Safety Information
o 5.17 Adverse Drug Reaction Reporting
o 5.18 Monitoring
Good Clinical Practice (GCP) E6
guideline when developing the
application and the protocol for
the Institutional Review Board
(IRB). Considerations include:
•
•
•
•
•
Safety
Storage and maintenance
of the investigational
product (IP)
Drug handling
Adverse event reporting
Monitoring.
Launch of InvestigatorInitiated Research
Launching IIR is quite different
than launching a study that has
a traditional pharmaceutical or
manufacturer sponsor, although
similar processes can take place
(Table 2). Processes that are
similar for both types of studies
include training the study team
and handling the IP.
In IIR, the SI is responsible
for ensuring compliance and
safety at every step. This
requires considering who will
handle compliance checks
26
TABLE 2
Launching Investigator-Initiated Research
•
•
•
•
Different than launching a traditional drug study
Some processes are similar
Sponsor-investigator is responsible for ensuring compliance
and safety
If a drug as de昀椀ned by the FDA is used, an IND application
is necessary
and monitoring. If the IIR is
using a drug (either a new
drug or a new indication),
an Investigational New Drug
(IND) application must 昀椀rst be
submitted to the U.S. Food and
Drug Administration (FDA) and
approved by the agency.
Our SI was a pediatric gastroenterologist who was interested
in evaluating the ef昀椀cacy of a
SOCRA SOURCE © May 2024
probiotic versus 昀椀ber versus
placebo for treating children who
had irritable bowel syndrome.
The SI had secured funding
through NIH. To determine if
an IND was needed, a call was
made to the FDA.
The FDA de昀椀nes a drug as:
•
A substance recognized by
an of昀椀cial pharmacopoeia
or formulary.