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Table of Contents
Temperature Excursion Data Collection Form (DCF)............................................................................2
1.0 Study and Location of Current Excursion........................................................................................ 3
2.0 Description of Current Excursion.................................................................................................... 4
3.0 Material Involved in Excursion........................................................................................................ 6
4.0 Disposition Decision (for Lilly Use Only)......................................................................................... 7
Revision History.................................................................................................................................... 8

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Temperature Excursion Data Collection Form

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Temperature Excursion Data Collection Form (DCF)

It is critical these instructions be followed. Accuracy of the data on this form is vital and most will be verified. If incorrect
information is discovered the form will be rejected resulting in a delay in determining if the material is fit for use.
Sites/affiliate-managed depots should closely monitor temperatures and report temperature excursions. If an excursion is
discovered by a site manager/monitor during an investigator site visit, this form may be completed by the site manager/monitor.
WHAT QUALIFIES AS A TEMPERATURE EXCURSION?

An event lasting 15 minutes or greater in which material has experienced a temperature fluctuation outside of the
acceptable storage conditions as indicated on the label (after rounding rules have been applied).
o Temperature rounding rules:

If the excursion is reported at 0.5C and above, round up (that is,1.5C would be rounded up to 2C)

If the excursion is reported at 0.4C and below, round down (that is, 8.4C would be rounded down to 8C)

A period of time during which the material was not monitored (no min/max temperatures recorded).

USE THIS FORM WHEN:

An excursion occurs at an investigator site, including site to satellite site transfers or transfers to a new site address
An excursion occurs at an affiliate-managed depot or in-transit from an affiliate-managed depot to an investigator site.
DO NOT USE THIS FORM IF:

Material is no longer needed (for example, trial has ended) AND the affected material was NOT used by a
subject. In this situation, reporting of the temperature excursion is not necessary and processes for
managing returns or destruction should be followed.

Non-Lilly commercial material was purchased directly by the investigative site. Call the phone number on
the package insert for a disposition decision by the manufacturer.

INSTRUCTIONS FOR THE INVESTIGATOR SITE/AFFILIATE-MANAGED DEPOT

1. Segregate the affected material and ensure the material continues to be stored according to the product label (either in a
separate storage area or in a physical barrier within storage area). Clearly mark material as quarantined or do not
dispense (not directly on the packaging). If affected material was dispensed to patient, patient should be contacted to
discontinue use and return any unsed portion.
2. In the event that the Interactive Voice Response System/Interactive Web Response System (IVRS/IWRS) dispenses affected
packages before receipt of the fit for use decision on the DCF, contact the IVRS/IWRS Support group so action can be taken
to provide replacement packages.
3. Verify the excursion has ended and the storage conditions have returned to the acceptable temperature range.
4. Patient visits should be rescheduled until a formal disposition can be provided or replacement IP is supplied. Please
confirm that any new shipment received is truly a replacement and not just a standard resupply.
5. Report excursion by submitting this form within 1 business day of material being returned to acceptable temperature
conditions.
COMPLETING AND SUBMITTING THIS FORM FOR AN EXCURSION
1. Complete sections 1 through 3 for the temperature excursion(s). All entries must be complete for submission.
2. For inventory needs, please indicate on the form in section 2.0.
3. Submit this completed form within 1 business day of material being returned to the acceptable temperature conditions
o Submit as a typed, editable Word document (NO PDF) to CTMM@lilly.com
o

Include the site manager/monitor (that is, Clinical Research Associate [CRA]) in the e-mail.

File a copy of the completed form with the study documentation. For investigator sites, file in the investigator Trial
Master File (iTMF). For blinded studies, please ensure that blinded personnel do not have access to the document.
4. If you have any questions, contact the Temperature Excursion Investigation Center (TEIC) at 1-317-433-0022.
o

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1.0 Study and Location of Current Excursion

Trial alias (XXX-XX-XXXX):

Investigator site number:

Country

Clinical site or depot point of

contact:

E-mail:

Back-up clinical site or depot

point of contact:

E-mail:

Site manager or monitor name(s):

(clinical research associate)

E-mail:

Lilly clinical development liaison,

clinical development consultant or
regional research manager name
(if applicable):

E-mail:

Street address of investigator site

or affiliate-managed depot:
Additional address data (that is,
facility name):
City, State:
Zip/Post code:

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2.0 Description of Current Excursion

The TEDCF should not be completed until the storage conditions have returned to the acceptable temperature range.

Cause of Excursion
(check most appropriate reason)

Excursion Comments
(explain excursion circumstances, ensure
explanation agrees with data in Sections 2 and
3)
Inventory Needs

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Temperature Excursion Data Collection Form

Refrigerator malfunction
Refrigerator door opened for extended period (that is, during
restocking, door ajar)
Material located too close to refrigerator fan (that is, back of
refrigerator)
Material left out of refrigerator
Material not refrigerated upon receipt
Power failure/electrical disruption
Temperature not monitored
Fluctuating temperatures in storage room (for example, air
conditioning/heat turned off)
Other, please specify: _____________

Check here if patient visits are planned within the next 8 business
days and CANNOT be rescheduled.

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Use a temperature log, if available, to complete this form (do not attach to this form).

When no temperature log is available, estimate using the worst case scenario
o
o

Amount of time the product was out of the required temperature

The highest and lowest temperature to which the product was exposed (for example temperature setting of
Heating and Air system).

When material has gone in and out of range multiple times, list each occurrence on a separate line.

Last date and time in acceptable storage

conditions prior to excursion

Highest and lowest

temperature during
excursion

hh:mm
(24 hr clock)

dd-mmm-yyyy

hh:mm
(24 hr clock)

Minimum
temperature
(XX C)

Maximum
temperature
(XX C)

07:15

02-Aug-2012

13:38

3 C

11 C

dd-mmm-yyyy
Example

Date and time returned to acceptable

storage conditions

01-Aug-2012

Storage condition on the label

(temperature requirements)

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3.0 Material Involved in Excursion

1. For ALL material involved in the current excursion, list the lot number and package numbers (if applicable).
2. If package numbers are consecutive, a range can be listed unless a package was dispensed in which case the dispensed
package should be listed separately.
3. If there were previous excursions ensure it is clear which packages were affected by which previous excursions by listing
them on separate line items where necessary.
4. Do not include any attachments with this form (for example Excel spreadsheets, IWRS/IVRS logs, pdfs).
5. Please indicate if the material was dispensed to a patient but not consumed by, administered to or injected into the
patient.
Did the material have a previous
excursion?

Material involved in the current excursion

Example

Lot number
(If the lot does
not begin with C
or CT, also
provide a
compound name
and
manufacturer)

Date
dispensed
to subject
Package (dd-mmmnumber
yyyy)
(If none,
indicate N/A)

Subject #
Enter 1
subject
number per
row
(If none,
indicate
N/A)

Describe any
adverse events
(If none, indicate
N/A)

When yes, list the previous

excursion Tracking number
Check study binder to determine
No Yes if the same lots/packages had a
previous excursion (past and
current excursion data is used to
determine Fit For Use status)
H8A_0123456789_DCF
(number may be between 7 to
10 digits)

23456

01-Jan2000

3100

headache,
nausea

if lot does not

start with C
Lot # 23456,
compound x,
manufacturer x

N/A

N/A

N/A

N/A

Add additional
rows as
necessary

Example

C123456 or
CT123456

What is the package

configuration?

Bottle

Is any material above for a

Bioavailability or
Bioequivalent (BA/BE)
study?

Yes

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Blister

Vial

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Syringe/Pen

Other-Describe _____________

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4.0 Disposition Decision (for Lilly Use Only)

Excursion ID #

Based on the data supplied in sections 1 through 3 of this form as well as data from excursions occurring prior to the sites receipt of the
material (that is, during manufacturing, packaging and transportation), the following disposition has been given to the aforementioned
material affected by this temperature excursion:

Material is fit for use.

Material no longer needs to be segregated and may be dispensed per protocol.
Applies to all material referenced in section 3 of this form.
Applies ONLY to lots and packages listed below:

Comments:

Lot number

Package number (if applicable)

Material is NOT fit for use.

Follow instructions from your site manager/monitor for what to do with the material. If material is for a BA/BE
(Bioavailability/Bioequivalent) study DO NOT DISCARD. Your site manager/monitor will escalate the information.
If submitted by affiliate-managed depot, make the material unavailable in distribution system.
Applies to all material referenced in section 3 of this form
Applies ONLY to lots and packages listed below:

Comments:

Lot number

Package number (if applicable)

Material is Fit For Use, no Health Hazard Evaluation (HHE) required.

Material is NOT Fit For Use and was not dispensed to patients, no HHE required.
Material is NOT Fit For Use and was dispensed to patient(s), No impact on subject safety; no HHE was necessary.
Documentation is filed with the investigation form.
Material is NOT Fit For Use and was dispensed to patient(s); an HHE was necessary and has been completed.
Study Manager has been notified. Documentation is filed with the investigation form.
Signature below indicates agreement with the disposition indicated.
/
Initial verification (print/sign/date)
/
Secondary verification (print/sign/date)

SEQSM442-007-TL01-v1.1-05OCT2015
Temperature Excursion Data Collection Form

Confidential