The Anatomy of a Global Clinical Trial Label
Even in an increasingly challenging regulatory environment, the globalization of clinical trials shows no sign of slowing. As more and more pharma companies and CROs set their sights on emerging regions to carry out clinical trials, they are able to recruit patients from more diverse markets and gain more insight than ever before.
Of course, this means quality translation becomes vital. And when translation and localization come into play, one of the most critical components to think about is clinical labeling. First things first: what does a compliant clinical trial label look like? This infographic strips EU-ready IMP content down to the basics.
See the full infographic here!
You can also learn more about how global clinical labeling solutions help support compliance in our eBook.
Anatomy of a Clinical Trial Label: The Unauthorized IMP/A label*
Flawless labels are critical to the success of your global trials.
Are your clinical labels patient- and clinician-friendly and regulatory-compliant?
The EU specifies the following label content for unauthorized IMP/A labels:
A. Main contact information (Sponsor/CRO/Investigator
B. Substance name & potency
C. Pharma form, route of administration, quantity of dosage units
D. Batch or code number identifying contents and packaging operation
E. Subject identification number and/or treatment number, and visit number when relevant
F. Clinical trial reference code
G. Name of investigator [if not in (a) or (e)]
H. Directions for use (may include reference to booklet and other documents)
I. The storage conditions
J. ‘For clinical trial use only’ or similar wording
K. Period of use (expiry) in month and year format
L. ‘Keep out of reach of children’ except for trials with non-home use
Multiple factors can affect label layout, creation, and usability:
- Text expansion: Translated text can increase or decrease in size.
- Legibility: Follow font guidelines for usability and compliance.
- Format: Choose the best option from single, two panel, or booklet labels.
Multilingual clinical labeling can seem overwhelming, but experts can help you master the linguistic, regulatory, and delivery requirements for single-site or global trials.
Visit lionbridge.lifesciences.com to learn more about best practices for clinical label management.