To help companies conducting clinical trials in multiple countries
ISPE, the Tampa, Florida, US-based International Society for Pharmaceutical Engineering, has published 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 labelling methods to international regulatory authorities.
“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,” said ISPE President and CEO Nancy Berg.
“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.”
MHRA officials in the UK have reviewed The ISPE Good Practice Guide: Booklet Labels and their feedback has been incorporated into the publication. ISPE says the recommendations will help companies determine the gaps between their current booklet label procedures and best practices. The guide 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.