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Y and Infectious Diseases (NIAID) Date: Protocol Number: Investigator of Record Name: Clinical Research Site Name: Clinical Research Site Number: Investigational Product Name: Strength and Dosage Form: Package Size: Manufacturer: Lot Number(s): Required Storage Temperature: Box number(s) affected: Hereby we would like to inform you about a temperature excursion that occurred at site indicated above, that was reported on date: and occurred on date: . Te.

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Refrigerator Storage: 2°C to 8°C 3. Freezer Storage: -25°C to – 10°C 4.

Acceptable Temperature Ranges for Devices Used for Storage of Investigational Product:Storage DeviceCelsiusFahrenheitControlled room temperature15°to 25°59°to 77°Refrigerator2°to 8°35.6°to 46.4°-20°C Freezer-25°to -10°-13°to 14°-80°C Freezer-84.

A temperature excursion occurs when any temperature reading is outside the recommended range for vaccine as defined in the manufacturer's package insert. Vaccines must always be stored properly, even if viability is questionable.

The maximum temperature excursion should be NMT 40°, as 40° is the standard ICH accelerated condition for room temperature drug products. If satisfactory stability data is available, temperature excursions beyond 40° could be accepted. Temperatures higher than 40° increase the likelihood for product degradation.

The primary USP controlled room standard for facilities to understand is USP 797, which specifies that clean rooms should be kept at a temperature of 68 °F (20 °C) or below, however, full compliance depends on the type of facility.

Objectives: The United States Pharmacopoeia (USP) recommends that medication storage temperatures should be maintained between 15 degrees C and 30 degrees C (59 degrees F to 86 degrees F). Concerns have been raised that storage temperatures in EMS may deviate from this optimal range, predisposing drugs to degradation.

Temperature Excursion: A temperature reading outside of the acceptable temperature ranges and outside of the acceptable storage temperatures as defined per individual protocol AFTER rounding rules are applied. Investigational product (IP): A new drug or biological drug that is used in a clinical trial.

2.2 Study product storage Study product should be stored in a limited-access location and ing 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.

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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232