Guidance for Standardising Use of Booklet Labels in Global Clinical Trials

ISPE, a leading authority on best practices for the pharmaceutical industry, has issued the industry’s first-ever guidance to help companies conducting clinical trials in multiple countries standardise their use of booklet labels. The Guide provides templates, guidelines and tools to make it easier for companies to use booklet labels consistently and effectively and justify their booklet label methods to international regulatory authorities.

“ISPE is pleased to introduce its first Guide to support harmonisation of labelling requirements globally,” said ISPE President and CEO Nancy S. Berg. “Companies involved in clinical trials now have a resource that provides guidance on how to design and structure a booklet label and how to standardise the use and application of booklet labels for global clinical trials. By following the recommendations presented in the Guide, companies can feel confident that their booklet label strategy is supported by a scientific, risk-based methodology and patients are receiving accurate, complete instructions in their local language.”

The ‘ISPE Good Practice Guide: Booklet Labels’ has been reviewed by MHRA officials and their feedback has been incorporated into the Guide’s content. The Guide’s recommendations will help companies determine the gaps between their current booklet label procedures and best practices. It contains resources for training clinical trial personnel on proper booklet label use and templates that companies can put into practice immediately to help improve compliance and cost-effectiveness of their clinical trials.

The ISPE Good Practice Guide: Booklet Labels is available for purchase on the ISPE website.

ISPE. +1 813 960 2105, ext. 277, dhould@ispe.org, www.ispe.org.