FDA E6 (R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)

  FDA

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and the well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.

This E6 (R2) document addresses the good clinical practice, an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. It aims to provide a unified standard for the ICH regions to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdiction.

What is ICH E6 R2?

The first version of the ICH E6 Good Clinical Practice (GCP) Guideline was finalized in 1996 describing the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and IRBs. GCP covers aspects of monitoring, reporting and archiving of clinical trials, and incorporates addenda on the Essential Documents and on the Investigator’s Brochure.

Effective Quality Oversight in ICH E6 R2

Central Statistical Monitoring (CSM) is key to compliance with ICH E6 R2 and organizations can  ensure a successful implementation of RBx driven by CSM.

CSM uses statistical methods to identify unexpected or unusual patterns in clinical data, and is ideally composed of at least the following four components:

FDA Announces ICH E6(R2) Guidance

U.S. Food and Drug Administration (FDA) announced guidance for Good Clinical Practice (GCP), entitled “E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1).” This guidance represents the current thinking of the FDA.

This integrated addendum guideline was collaboratively developed by the International Council for Harmonization with input from the FDA. ICH E6(R2) “discusses approaches to clinical trial design, conduct, oversight, recording, and reporting as well as updated standards regarding electronic records and essential documents.”

How are the Companies Responding to E6 (R2)?

At a recent industry round table to better understand the impact of ICH E6 R2 and the perception of the new guidance by pharmaceutical companies, attendees confirmed most organizations have made significant progress and have the amendment on their near-term road-map. Groups are working with their technology departments to incorporate algorithms and account for the sensitivity of smaller trials. Major pharmaceutical companies are starting to perform risk assessments and gap analyses of organizational procedures to identify where the company stands and determine areas that have the most impact on the credibility of data and that will be most impacted.

Summary
FDA E6 (R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)
Article Name
FDA E6 (R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)
Description
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and the well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.
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Plianced Inc.
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