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SOP 605 TempMonitoring

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SOP 605 TempMonitoring

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© © All Rights Reserved
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Standard Operating Procedures for Clinical Research at Kent State University

TEMPERATURE MONITORING

SOP#: 605 Version: 1.0 Page: Page 1 of 3

PURPOSE: The purpose of this SOP is to describe the procedures to be followed for
temperature monitoring of investigational products and biological substances stored at Kent
State University (KSU) for use in clinical research studies. The following procedure must be
followed in order to avoid the risk that products or substances become unstable.

SCOPE: This SOP applies to Investigators and research personnel who store and monitor
investigational products, vaccines and specimens at KSU.

RESPONSIBILITIES: The PI and designated study personnel are responsible for temperature
monitoring of study medications stored at KSU and for reporting any extreme deviations in
temperature immediately to the appropriate facilities personnel and/or Sponsor.

DEFINITIONS:

Investigational Products (IP): 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 (formulated or packaged) in a way different from the
approved form, or when used for an unapproved indication, or when used to gain further
information about an approved use.

National Institute of Standards and Technology (NIST): A non-regulatory federal agency


within the U.S Department of Commerce. NIST's mission is to promote U.S. innovation and
industrial competitiveness by advancing measurement science, standards, and technology in
ways that enhance economic security and improve our quality of life.

PROCEDURE:

1. The PI, or assigned research personnel, shall perform daily temperature monitoring of
research storage cabinets during normal business hours Monday- Friday.

2. When the clinic is closed on weekends, holidays or during mandatory evacuations, the
staff will read the minimum and maximum temperatures on the next business day
morning and record the results on the building temperature log, if available.

Traceable Refrigerator/ Freezer Thermometers will be affixed to the outside of all of the
refrigerators/freezers noted above.
2.1. The traceable thermometers will be calibrated and re-certified at least once
annually using instruments traceable to NIST.
2.2. The thermometer sensor that contains a vial of ethylene glycol will be placed in a
location that is representative of the average temperature of the unit, and away
from a source of incoming refrigerated air or near the freezer to avoid
misrepresentative temperature readings.
2.3. Ethylene glycol in the vial that contains the temperature sensor is mildly toxic. If
the vial is broken and ethylene glycol leaks, research personnel will clean the
Standard Operating Procedures for Clinical Research at Kent State University

TEMPERATURE MONITORING

SOP#: 605 Version: 1.0 Page: Page 2 of 3

spill using disposable paper towels and water. Proper use of personal protection,
such as disposable gloves, shall be used.

3. Ambient drug storage will be monitored by a calibrated thermometer provided by the


sponsor. If not provided, it may be measured by the same Thermometer referenced
above or may be measured by wall thermostat located in the same room where the
study drug is stored.

4. Temperatures will be documented daily on a separate temperature log for each storage
location.
4.1. Each refrigerator/freezer used for storage of research is labeled with assigned a
uniletter and with the same thermometer mounted on the outside of each
designated refrigerator or freezer.
4.2. Minimum and maximum temperatures for medication refrigerators shall be read
and manually recorded on a temperature log once daily and the memory reset
each time.
4.3. A temperature log will be kept outside of the each refrigerator/ freezer door and
will contain the following documentation clearly written in ink:
 Location identification
 Date
 Time
 Results
 Initials of person responsible
 Comments if necessary

5. Historical temperature logs for all refrigerators/freezers will be maintained in a central


location by the CRC.

5.1. The traceable thermometers will be calibrated and re-certified at least once
annually using instruments validated against NIST certified device. Refer to
SOP #604: Equipment Maintenance and Calibration.

6. The CRC Manager or research designee will report any temperature excursions
immediately to the study PI and research coordinator. He/she will inform all the trial
sponsors whose supplies are stored in that are to request confirmation that the product
is fit for continued use. This should be in writing via email with a copy of the relevant
graph.

7. Study staff will follow any study specific procedures for reporting temperature excursions
provided by the sponsor detailed in the pharmacy clinical trial file.
Standard Operating Procedures for Clinical Research at Kent State University

TEMPERATURE MONITORING

SOP#: 605 Version: 1.0 Page: Page 3 of 3

8. If the temperature fails to return within normal limits, the CRC manager or research
personnel may move the supplies to an alternative area in the CRC, Byrd Institute or
Eye Institute and notify the sponsor immediately.

9. Research personnel will document all actions taken in a file note and place a copy in the
files of each study affected.

10. In the event of a clinic power failure, all refrigerators and freezers will switch to the
emergency power generators.

ICH GCP E6. Section 4.6 Investigational Product(s)

REFERENCES:

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