ISPE Good Practice Guide: Booklet Labels

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Published: March 2013
Pages: 42
Table of Contents ( 226 KB)

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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 enables 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:

  • Reduce/eliminate risks and concerns addressed by sites and regulators
  • Increase operational efficiency while ensuring subject safety
  • Reduce errors in design process, allow for printing standardization and reduce delays during distribution process
  • Reduce dispensing errors by sites
  • Allow subjects and staff to become familiar with label design, so they know where to look for information
  • Allow for standardized training of sites and subjects in product handling, use of booklet labels and Use-by dates.
  • Reduce costs and delays due to destruction or re-labeling for products with extended expiry dates
Last Update: 17 June 2013

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