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Good Clinical Practice (GCP) is the internationally- recognized standard for the design, conduct, recording and reporting of clinical trials involving human subjects. Adherence to the principles of GCP is essential in ensuring ethical standards and scientific quality, while providing public assurance that the rights, safety and well-being of trial subjects are protected. This website focuses on the practical implementation of GCP standards, with an emphasis on training and development.

 

 

  • ICHGCP
  • IPR Guide
In response to the changes that have occurred in the clinical trial arena, for the first time in 20 years the International Conference for Harmonization (ICH) Good Clinical Practice (GCP) E6 has been amended “to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and data integrity.” This includes the update of key clinical trial standards, as well as the provision of unified standards across regions in an effort to improve the quality and efficiency of clinical trials.
 
With the impending release of the final guideline in November 2016, the clinical trial industry must prepare. While the proposed revisions are intended to modernize and encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, documentation, reporting,  and human subject protections, the proposed changes also  have resounding effects and impact on sponsors/CROs and investigators. As such, systematic analysis to ensure adherence to these proposed clinical trial standards is essential.
 
This website is dedicated to providing resources that can assist companies in preparing for these changes. Included are a number of training courses, webinars, self-paced learning modules and publications that assist industry professionals in navigating the myriad of changes associated with the ICH revision.

Areas Impacted by the Update include:
  1. Sponsor Quality Management: Risk-Based Quality Management (RBQM) *new*
  2. Sponsor system for managing trial quality: risk-based/risk management approaches to clinical trials – is now a *requirement*- all clinical trials
  3. Sponsor oversight of CROs, and written approval of CRO sub-contractors *new*
  4. Certified Copy definition *new*
  5. Computerized Systems Validation definition *new *
  6. Monitoring Plan definition *new*
  7. Monitoring Plan: rationale for chosen monitoring strategy *new*
  8. Centralized Monitoring *new*
  9. Sponsor Monitoring Report review *new*
  10. Monitoring Report update: Centralized Monitoring outcomes documented *new*
  11. Computerized Systems Validation requirements *new*
  12. Investigator responsibilities *new requirements*-source data, supervision, third party oversight
    ALCOA – addition of the C for complete! *new*
  13. Investigator significant non-compliance: sponsor implement root cause analysis and CAPA, serious breach reporting *new*
  14. Updated ICH Principle for clinical trial information

Barnett's On-Demand
GCP REFRESHER TRAINING

Too busy to attend a course? Our newly- released GCP eLearning course may be your solution. For details on our scenario- based practical GCP application on- demand course, click here


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2016 GCP Question & Answer Guide

Available in Hard Copy & Electronic Editions!  

BARNETT CATALOG

July 2016 - January 2017 Edition Now Available  

-Download Today! 

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