The ICH E6(R2) Addendum: An intro to the what and why of the changes

By Katie Mitchell

Since finalization in May of 1996, the Guideline for Good Clinical Practice E6(R1) produced by the International Conference on Harmonization (ICH), has provided clinical trial research with a set of procedural standards to ensure quality data and protection of human subjects. The document has continued to be a guiding presence in the industry over the past twenty years; however, increases in both magnitude and intricacy of clinical trials has prompted a need for modernization of the content. At the guideline’s inception, the vast majority of trials were paper-based, which is in stark contrast to the technological focus of today’s trials. The industry has also experienced a move toward risk-based methodologies to improve efficiency of the rapidly growing trial landscape. The universal shift toward electronic records, data capture systems and risk-management has led to changes in the conduct of trials not only to clarify the processes, but to redefine the responsibilities of the individuals executing them. For all these reasons and more the ICH has rolled-out the Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2).

Prior to reading the addendum, a quick scan of the document history and table of contents illustrates the numerous changes that have been incorporated into nearly every section. Nowhere is this more apparent than in the evolving duties of the Sponsor. In fact, the changes are so numbered they will be addressed in a blog all their own. The following will identify and discuss the changes to the guidance in the introduction, glossary, principles of ICH GCP, Investigator and essential documents sections.

 

• Introduction

 

• Immediately following the introduction is the first addendum elucidating the advancement of the industry since 1996.  This has led to changing procedures in all aspects of research necessitating updated standards. To illustrate this point, an example is offered regarding the expansion of the original section guiding the use of centralized monitoring.  

 

• Glossary (1.63,1.64,1.65)

 

• The addendum to the glossary is comprised of three new definitions: certified copy, monitoring plan and validation of computerized systems. “Monitoring plan” is defined here simultaneously with the Sponsor sub-section; therefore, it will be addressed in the subsequent blog. “Validation of computerized systems” imparts the need to document that the computer system will perform as it should for the duration of the study. While the term “certified copy” was previously used in the definitions of both source documents and source data. It has now been given a spot of its own in the glossary to clarify validation of a copy.

 

• Principles of ICH GCP (2.10,2.13)

 

• Addendum 2.10 outlines the overall handling of trial information from the start of the clinical trial to the end. The addendum clarifies that the standards of ICH GCP should apply to all information, paper or electronic. Sub-section 2.13 indicates that system procedures ensuring trial quality should be implemented to secure protection of human subjects and data quality.

 

• Investigator (4.2.5, 4.2.6, 4.9.0)

 

• The Principal Investigator is responsible for ensuring that delegates of trial-related tasks are qualified and properly trained.  As part of providing adequate oversight of the delegates, the Principal Investigator is responsible for confirming the tasks are performed correctly and fully. Lastly, the Principal Investigator is charged with the upkeep of source documentation and trial records. Making its way into the updated version of the guideline in this addendum is the previously unmentioned, ALCOA. All five attributes: attributable, legible, contemporaneous, original and accurate are included along with the additional   term “complete”.  Some are referring to the enhanced acronym as ALCOA-C.

 

• Essential Documents for the Conduct of a Clinical Trial (8.1)

 

The addendum allocates the responsibility of essential document and source document maintenance to the Sponsor and Investigator. Furthermore, the addendum makes note that the Sponsor should ensure the Investigator has control of the case report form.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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