SEQSM442-007-TL01-v1.0_1

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Table of ContentsTemperature 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

SEQSM442-007-TL01-v1.1-05OCT2015Temperature Excursion Data Collection Form Confidential

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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,1.5°C would be rounded up to 2°C)

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

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 [email protected]

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

o 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.


mailto:[email protected]

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1.0 Study and Location of Current Excursion

Trial alias (XXX-XX-XXXX): Investigator site number: Country

Street address of investigator site or affiliate-managed depot:

Additional address data (that is, facility name):

City, State:

Zip/Post code:

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:


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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)

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: _____________

Excursion Comments

(explain excursion circumstances, ensure explanation agrees with data in Sections 2 and

3)

Inventory NeedsCheck 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 Amount of time the product was out of the required temperature

o 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

Date and time returned to acceptable storage conditions

Highest and lowest temperature during

excursion

dd-mmm-yyyyhh:mm

(24 hr clock)dd-mmm-yyyy

hh:mm

(24 hr clock)

Minimum temperature

(XX °C)

Maximum temperature

(XX °C)

Exa

mpl

e

01-Aug-2012 07:15 02-Aug-2012 13:38 3 C 11 C

C C

C C

C C

C C

C C

C C

C C

C C

C C

C C

C C

C C

C C

C C

C C

C C

C C

Storage condition on the label

(temperature requirements) C


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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, pdf’s).5. Please indicate if the material was dispensed to a patient but not consumed by, administered to or injected into the

patient.

Material involved in the current excursion Did the material have a previous excursion?

Lot number

(If the lot does not begin with C

or CT, also provide a

compound name and

manufacturer)

Package number

Date dispensed to subject (dd-mmm-

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)

No Yes

When yes, list the previous excursion Tracking number

Check study binder to determine if the same lots/packages had a previous excursion (past and current excursion data is used to determine Fit For Use status)

C123456 or CT123456

2345601-Jan-2000

3100headache, nausea

H8A_0123456789_DCF

(number may be between 7 to 10 digits)

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

What is the package configuration? Bottle Blister Vial Syringe/Pen Other-Describe _____________

Is any material above for a Bioavailability or Bioequivalent (BA/BE) study?

Yes


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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:

Lot number Package number (if applicable) Comments: 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:

Lot number Package number (if applicable) Comments: 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-v1.0_1

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