Investigational Product: procurement, storage, labeling procedures is included in this presentation.

1. INVESTIGATIONAL PRODUCT

2. INVESTIGATIONAL PRODUCT
 According to ICH E6, 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 authorization when:
 Used or assembled in a way different from the approved form
 Used for an unapproved indication
 Used to gain further information about an approved use.
 An investigational product refers to a preventive (vaccine), a therapeutic (drug
or biologic), device, diagnostic, or palliative used in a clinical trial.
 An investigational drug can also be called an experimental drug and is being
studied to see if your disease or medical condition improves while taking it.
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3.  Scientists are trying to prove in clinical trials:
• If the drug is safe and effective.
• How the drug might be used in that disease.
• How much of the drug is needed.
• Information about the potential benefits and risks of taking the drug.
 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.
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4. Information on investigational product(s)
 When planning trials, the sponsor should ensure 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.
 The sponsor should update the Investigator's Brochure as significant new
information becomes available.
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5.13. Manufacturing, packaging, labelling, and coding
investigational product(s)
 5.13.1. The sponsor should ensure that the investigational product(s) (including
active comparator(s) and placebo, if applicable) is characterized as appropriate to
the stage of development of the product(s), is manufactured in accordance with
any applicable GMP, and is coded and labeled in a manner that protects the
blinding, if applicable. In addition, the labeling should comply with applicable
regulatory requirement(s).
 5.13.2. The sponsor should determine, for the investigational product(s),
acceptable storage temperatures, storage conditions (e.g. protection from light),
storage times, reconstitution fluids and procedures, and devices for product
infusion, if any. The sponsor should inform all involved parties (e.g. monitors,
investigators, pharmacists, storage managers) of these determinations.

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 5.13.3. The investigational product(s) should be packaged to prevent
contamination and unacceptable deterioration during transport and storage.
 5.13.4. In blinded trials, the coding system for the investigational product(s)
should include a mechanism that permits rapid identification of the product(s) in
case of a medical emergency, but does not permit undetectable breaks of the
blinding.
 5.13.5. If significant formulation changes are made in the investigational or
comparator product(s) during the course of clinical development, the results of
any additional studies of the formulated product(s) (e.g. stability, dissolution
rate, bioavailability) needed to assess whether these changes would significantly
alter the pharmacokinetic profile of the product should be available prior to the
use of the new formulation in clinical trials

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 Recipient verifies shipment and signs receipt
 Inventory logs are maintained by investigator or staff
 Storage conditions also maintained.
RECEIPT/INVENTORY/STORAGE

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STUDY PRODUCT STORAGE
 Study product should be stored in a limited-access location and according to
instructions received from the supplier, distributor, or manufacturer.
 Proper storage conditions should address the temperature, light, moisture,
ventilation, and sanitation needs of the study product.
 A log of key environmental conditions should be kept (e.g., a manual log or an
automated recording of temperature and humidity) to document that required
conditions were maintained during the entire storage timeframe.
 Environmental controls (e.g., for temperature or light) may also be needed
during transport between the pharmacy and the dispensing area.
 Meeting these handling requirements should also be documented.

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 Study products that are to be shipped offsite for a protocol must be packaged in
containers that maintain the proper storage conditions during transport.
 Maintenance of proper storage conditions during transport should be
documented if possible.
 Chain of custody documentation should also be maintained for the transport,
handling, and receipt of study product.
 If storage conditions have been compromised (e.g., temperature excursions from
the allowable range), or if there is any suspicion that the study product has not
been stored properly:
 Quarantine the study product.
 Maintain the study product under the correct storage conditions until
further notice.

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 Contact the Investigator immediately, providing the protocol number, the
protocol name, description of the degree of temperature/storage violation, and
the length of storage violation time.
 Document the occurrence and the action taken per Investigator input (e.g.,
return to general inventory, return to the manufacturer, onsite destruction).
APPROPRIATE TEMPERATURE LIMITS:
1. Room Temperature: 15-25 C
2. Refrigerator Temperature: 2 – 8 C
3. Freezer Temperature: -18 to -25 C

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USE OF DATA LOGGERS
 The most comprehensive temperature monitoring at a site can be achieved by
using so called data loggers .
 These are devices that continuously record the temperature in the room they are
placed in .
 The temperature is measured and recorded at pre-defined intervals(can be
anything between 1sec to several hours , recommended interval : once or twice
per hour).
 In regular intervals (typically once per month) the data is downloaded onto a
computer with the adequate software (which has to be purchased separately) .
 On the computer the data can be reviewed either as tables or graphs, which also
can be printed and filed as appropriate.

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Immediate Container Labeling
• Clinical trial number
• Generic name followed by the standardized identifier in parentheses
• Dosage, concentration, and strength
• Formulation (whether it’s a tablet, capsule, solution, etc.)
• Quantity
• Lot or batch number
• Expiration date and retest date
If not printed on the pharmaceutical labeling, these must be present on the packing
slips included in each shipment
• Medication number (only if it is a blinded study)
• Storage requirements
LABELING

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• Name and address of the sponsor
• The CFR statement
• “Caution: New Drug—Limited by Federal law to investigational use.”
Outer Packaging Labeling
 Product name
 Dosage, strength, and concentration
 Formulation
 Protocol number
 Quantity
 Lot or batch number
 Storage requirements
 Barcode to identify the product when scanned

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REFERENCES
1. https://www.wikidoc.org/index.php/Storage_and_handling_of_investigational_pr
oduct#:~:text=2.2%20Study%20product%20storage%20Study,needs%20of%20the
%20study%20product.
2. https://www.luminer.com/articles/regulations-for-clinical-trial-labeling/
3. ICH E6 Guidelines (R2)
4. The university of kentucky office of research integrity and institutional review
board standard operating procedure.

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