Sponsor and Investigator Responsibilities for Management of Investigational Products

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Sponsor and Investigator Responsibilities for
Management of The Investigational Product
Good Clinical People
ICH-GCP Foundation Course

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A pharmaceutical form of an active ingredient or
placebo being tested or used as a reference in a clinical
trial, including a product with a marketing authorisation
when:
• Used or assembled in a way different from the
approved form,
• Used for an unapproved indication, or
• Used to gain further information about an approved
use.
Investigational Product (IP)
©2019 Good Clinical People Ltd.

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“The available nonclinical and clinical information
on an investigational product should be adequate
to support the proposed clinical trial.”
ICH-GCP Principle 4

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When planning trials, the sponsor ensures
that sufficient safety and efficacy data from
nonclinical studies and/or clinical trials are
available to support human exposure by the
route, at the dosages, for the duration, and
in the trial population to be studied
Information on Investigational Product
©2019 Good Clinical People Ltd. – Images from Volhah, used under license from Shutterstock.com

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The Investigator’s Brochure (IB) is a
compilation of the clinical and non clinical
data on the investigational product that are
relevant to the study of the product in human
subjects.
The sponsor updates the Investigator's
Brochure as significant new information
becomes available.
Information on Investigational
Product(s)

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What is a
nonclinical study?
It is a biomedical study which is not
performed on human subjects. It can
be a study conducted on animals (in
vivo) or in a lab (in vitro).

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“Investigational products should be manufactured,
handled, and stored in accordance with applicable
good manufacturing practice (GMP). They should
be used in accordance with the approved protocol.”
ICH-GCP Principle 12

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The sponsor:
(a) Takes steps to ensure that the investigational
product is stable over the period of use.
(b) Maintains sufficient quantities of the
investigational product used in the trials to
reconfirm specifications, should this become
necessary, and maintain records of batch
sample analyses and characteristics. To the
extent stability permits, samples should be
retained either until the analyses of the trial
data are complete or as required by the
applicable regulatory requirements,
whichever represents the longer retention
period.
Investigational Product Management:
Sponsor’s Responsibilities

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The sponsor ensures that written procedures include
instructions that the investigator/institution should follow
for the handling and storage of investigational product for
the trial and documentation thereof.
The procedures address adequate and safe receipt,
handling, storage, dispensing, retrieval of unused product
from subjects, and return of unused investigational product
to the sponsor (or alternative disposition if authorized by
the sponsor and in compliance with the applicable
regulatory requirements).
Supplying and Handling
Investigational Product(s)

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Storage Conditions Packaging Labelling Unblinding
Storage, Packaging and Labelling
The sponsor
determines, for the
investigational
product, acceptable
storage temperatures,
conditions, times,
reconstitution fluids
and procedures, and
devices for product
infusion, if any.
The sponsor packages
the investigational
product to prevent
contamination and
unacceptable
deterioration during
transport and storage.
The sponsor ensures
that the investigational
product is labelled in a
manner that protects
the blinding and
complies with applicable
regulatory requirements.
In blinded trials, the
coding system for the
investigational product
includes a mechanism
that permits rapid
identification of the
product in case of a
medical emergency but
does not permit
undetectable breaks of
the blinding.
©2019 Good Clinical People Ltd.

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The sponsor supplies the investigators with the investigational
product only after all required documentation has been obtained.
The sponsor ensures timely delivery of investigational product to
the investigators.
The sponsor maintains records that document shipment, receipt,
disposition, return, and destruction of the investigational product.
Maintains a system for retrieving investigational products and
documenting this retrieval.
Maintains a system for the disposition of unused investigational
product and for the documentation of this disposition.
Sponsor’s Responsibilities: Supplying
and Handling the Investigational
Product(s)

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Do these requirements apply
to the comparator? A
placebo?
Yes, they do, as the comparator,
including placebo, is included in
ICH-GCP’s definition of an IP.

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Can you explain what
randomization is?
Randomization is the process whereby a subject is assigned to a
treatment arm (either an actual dose of the investigational product under
study or to a comparator) automatically to ensure that the trial is
balanced across different stratified groups.
Randomization is often done using Interactive Response Technologies
(IRT). These come in the form of an internet-based Interactive Web
Response System (IWRS) or a telephone-based Interactive Voice
Response System (IVRS).

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The investigator follows the trial's randomization
procedures, if any, and ensures that the code is broken
only in accordance with the protocol.
If the trial is blinded, the investigator promptly
documents and explains to the sponsor any premature
unblinding (e.g. accidental unblinding, unblinding due to
a serious adverse event) of the investigational product.
Randomization Procedures
and Unblinding

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Investigator’s Responsibilities:
Investigational Product
Responsibility for investigational product accountability at the trial site
rests with the investigator/institution.
The investigator:
• Maintains records of the product's delivery to the trial site, the
inventory at the site, the use by each subject, and the return to the
sponsor or alternative disposition of unused product.
• Stores the investigational product as specified by the sponsor and in
accordance with applicable regulatory requirements.
• Ensures that the investigational product is used only in accordance with
the approved protocol.
The investigator, or a person designated by the investigator/institution,
explains the correct use of the investigational product to each subject and
check, at intervals appropriate for the trial, that each subject is following
the instructions properly.

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Can the Investigator
delegate IP management
responsibilities to a member
of his/her team?
Yes. Where allowed/required, the investigator/institution
may assign some or all of the investigator's duties for
investigational product accountability at the trial site to an
appropriate pharmacist or another appropriate individual
who is under the supervision of the investigator/institution.

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Want to learn more? Complete our ICH GCP Foundation
Course. Enrolll using either the QR code below or this link
https://goodclinicalpeople.thinkific.com/courses/GCPfound
ationcourse
Mallorie Mitchell-Dellac
goodclinicalpeople.com
+44(0)7539 505 344
ICHGCP20 (20% off the course)
Good Clinical People
ICH-GCP Foundation Course

Sponsor and Investigator Responsibilities for Management of Investigational Products

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