Warning Letters Reference Guide: 2016 Edition

Barnett International Publication
Warning Letters

Warning Letters are on the rise, and can be issued to any entity or individual involved in a clinical study, including sponsors, clinical trial monitors, investigators (including other site personnel), IRBs, and clinical research organizations. This unique guide begins with the framework of Warning Letters, laying out a course to learn from others’ mistakes. Readers can expect guidance on understanding current trends in Warning Letters, avoiding Warning Letters, and responding to a Warning Letter if necessary.

 This reference guide provides examples of key Warning Letters of pharmaceutical, drug, biologic, and device products, including:  


  • Failure to establish quality procedures, corrective and preventive action plans, and complaints records.
  • Failure to maintain distribution records of investigational products.
  • Failure to select qualified investigators.
  • Failure to provide information to investigators needed to conduct the study properly.
  • Failure to follow the protocol for recruiting subjects and following specified inclusion criteria.
  • Failure to ensure each study is conducted in conformance to the study plan and protocol.
  • Failure to maintain appropriate and accurate case histories of investigational observations.
  • Failure to properly monitor a clinical investigation.
  • Inadequate reporting of adverse events to the sponsor or IRB.
  • Inadequate medical device accountability.
  • Failure to maintain documentation of finished device acceptance to ensure that each finished batch of devices meets the acceptance criteria.

Price: $59.95



  • 'This book covers the “Rise in guidance documents, FDA initiatives, outcomes measures and more!' - Advisory Board Review Team
  • 'This book will be helpful to “managers, directors, younger CRC’s, (and) other people for training operations.” The book answers questions like “Who’s getting WL and why – software, electronic capabilities, electronic systems validations (future trends)” and gives answers to “questions you can’t answer.' - Director Clinical Affairs


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