The New ICH E6 Standard


Good Clinical Practices:

The New ICH E6 Standard

**An FDAnews Management Report**

Many clinical trial operators are struggling to master the complexities of the revised ICH E6.

The revision to ICH E6 Good Clinical Practices imposes new guidelines to use advanced technology, creating changes in trial design, conduct, oversight, recording and reporting and all the while, continue insisting on highest standards of human protection and data integrity.

And that’s not all. Guidelines regarding electronic records and essential documents to boost trial quality also are being updated.

Good Clinical Practices: The New ICH E6 Standard outlines the changes in the guideline and offers suggestions for implementing new requirements. Readers will learn about:

  •     New definitions or enhancements to existing glossary terms
  •     How information should be recorded, handled and stored
  •     Clinical investigators’ qualification requirements, supervision responsibilities, record keeping and reporting
  •     How to provide training and adequate resources to maintain quality management and risk management
  •     An increased focus on risk-based monitoring
  •     And much more.

Good Clinical Practices: The New ICH E6 Standard gives readers an understanding of how the evolution of technology has changed the focus of Good Clinical Practices and how to keep up with the changes.

Who Will Benefit:

  •     Medical Affairs Officers
  •     Director of Clinical Operations
  •     Regulatory Affairs Professionals
  •     Director of Publications
  •     Director of Clinical Trial Regulatory Management
  •     Clinical Trial Information…

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