The ICH on the fingertips

The ICH on the fingertips

As SSC, CRA or project manager, you need to know on the fingertips the ICH (International Conference on Harmonization). But do you know that last July the document was updated? If you knew, great! If not, it’s still time to catch up.

ICH E6 (R2)

Do not worry, it is currently a draft version of the « ICH E6 R2 » addendum to the Guidelines on GCP (= Good Clinical Practice). It is a « draft » and updated version for public consultation. The latest version dates back almost 20 years (1996!)…Since then, technology has evolved considerably, and therefore it was necessary to adapt the ICH. In this article we offer you a summary of significant changes made in the document.

1. The Investigator

In this new version of ICH, the role of the investigator is strengthened. A little reminder, the investigator is in charge of his team members (he ensures their qualification), to whom he delegates tasks. He must now settle procedures to ensure the tasks integrity carried out by his team and the data generated, considering the evolution and the increasing use of technology and computerized systems.

As for documentation, ICH principles now apply to source documents (in the old version of ICH, these principles were applied to the data transmitted to promoter and not to the source data). This means that the data sources should enable the identification of the subject, they must be readable, recent, original, accurate and complete. Any change must be drawn (the principle of audit trail) and should not hide the initial data. It should be explained if needed.

In addition, the investigator must have control of any key document he produces before, during and after the test, he should also have continuous access to the data transmitted to the promoter.

2. The Promoter

The biggest change in this version of ICH is the addition of a « Quality management » section. This quality management system passes through the development of procedures by the promoter. These procedures must be included in all stages of the clinical trial and should take into account the concept of « risk » to manage them if they arise. You can read here the article that was written about it on the blog.

Remember, the risks must be:

Identified at all levels of the system and the clinical trial,
Assessed: probability, impact, scale…
Controlled, as far as possible,
Communicated,
Reviewed for continuous improvement during clinical trials,
Reported in the clinical trial report. In case of significant non-compliance and to prevent it from happening again, it is important that the promoter analyzes the causes and implement corrective and preventive actions.

Considering the importance of the risk in clinical trials, monitoring with a risk-based approach will be systematic and prioritized. This concerns both on-site monitoring and centralized monitoring.

3. And else … what other changes?

Other suggested changes include:

Updated references regarding electronic records and essential documents in order to increase the quality and efficiency of clinical trials.
For example, their location must be documented by the investigator. Regarding additional documents which are not mentioned on the list of essential documents, they will appear on the TMF (= Trial Master File) for it to be as complete as possible. In case an original document misses, a certified copy may replace it, provided that it contains exactly the same information and features as the original. The definition of « Certified Copy » has also been added in this latest version of ICH (Part Glossary).
More effective approaches for the design, conduct, monitoring, data recording and reporting of clinical trials.
The assurance of a continued protection of participants in clinical trials and data integrity, for developments in technology.

Further changes were made to several sections of this guideline, including:

Monitoring plane (with the addition of its definition in the Glossary part)
Validation of computerized systems
Promoter (quality procedures and risk-based approach)
POS (= Standard Operating Procedures)

Generally, and in view of the clinical research evolution over the past two decades, the amendment suggests to implement new approaches based on risk, to better ensure the human subjects protection and data quality. It was therefore important that the guidelines evolve and reflect today’s clinical research.

If you would like further information or clarification on these guidelines, you can find the full document here, or on the ICH website by clicking here.

Contribute to the finalization of the guidelines, by posting a comment at the following address ich@ema.europa.eu. Indeed, the comments are open until January 31st, 2016 … then get your keyboard!

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