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