Published: March 2013
This Guide was written to create methods for standardizing the format, design, and content of clinical trial booklet labels. Because booklet labels contain vital information for testing sites and subjects, the Guide promotes more consistent use of booklet labels to reduce confusion and non-compliance.
In addition to suggestions for effective and compliant booklet label design, the ISPE Good Practice Guide: Booklet Labels includes recommendations and justification for placement of required information and whether it should be included on the label or elsewhere. This Guide is a valuable tool you can use to perform a gap analysis on your current processes and readdress them to: