Are you ready for the ICH GCP E6 (R2) Addendum?

Since the development of the first ICH GCP Guideline, the way clinical trials are conducted has been significantly affected by the technological advancements, such as the use of electronic data recording and reporting. The Addendum updates the guidance by covering Risk Management, Sponsor Oversight and Advances in Clinical Trial technology.

The Updated Guideline for good clinical practice (GCP), E6 (R2), was adopted by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on the 15th December 2016. The update came into effect in Europe on 14th June 2017 and it is critically important for organisations running clinical trials to understand the modifications, how these will affect them and what new approaches need to be adopted.

The CQA Company™ part of the TCTC Group™, is already working with many companies in order to successfully put into effect the Amendments into the Quality Management System (QMS) and supporting them in maintaining the highest levels of GCP compliance.

Being the most significant revision to International GCP, the new addendum ICH GCP E6 (R2) introduced 26 new items concentrated in the areas of data management, sponsor and investigator responsibilities. The new guidelines once implemented will have an international effect and everyone involved in clinical trial research will have to comply with the new requirements.

Investigator responsibilities specify that the investigator is entirely accountable for supervising the different individuals or parties that the investigator has delegated trial related responsibilities. In order to secure data credibility the investigator must adopt sufficient documented procedures and ensure that all trial operations are executed with integrity. It is therefore imperative that all procedures are monitored throughout the clinical trial process.

The new addendum assigns to the investigator the generation of documentation to be available upon request. To secure that these reports are credible and accurate the investigator is responsible to ensure that the trial records adhere to the regulations.

Sponsor Responsibilities have been revised to include 16 new items and become the section with the largest alteration. The implementation of a solid management system through the clinical trial process in order to secure quality in all stages is one of the main responsibilities of the Sponsor. This process is vital in ensuring the subject protection and reliability of outcome. A risk based quality management system is expected to be operated by the Sponsor which includes critical processes identification, risk evaluation, risk control, risk communication, risk review and finally risk reporting.

The Sponsor is also expected to oversee any trial-related duties including those subcontracted by a CRO. The Sponsor is also responsible for implementing a root cause analysis and a corrective and preventive strategy for any possible non-compliance that may occur along the process.

Considering all the above it is evident that the ICH-GCP E6 (R2) 2016 addendum is a challenging update that requires the appropriate training of all parties that need to ensure compliance.

If you would like assistance with implementation of the new amendment then The Quality Assurance Company™can supply the required Gap Analysis, Process mapping, Risk management and QMS development services to assist your company maintain the highest levels of GCP compliance.

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[Sources:

EMA, Submission of comments on ‘Guideline for good clinical practice E6 (R2)’ (EMA/CHMP/ ICH/135/1995), February 2016

Dr Colin Wilsher, RQA GCP Committee, ICH E6 rewritten to reflect recent GCP inspection findings, August 2015

ICH E6 (R2) Expert Working Group, Integrated Addendum to ICH E6 (R1): Guideline for Good Clinical Practice E6 (R2) Presentation, February 2017]

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