{"id":1357,"date":"2015-10-21T14:55:59","date_gmt":"2015-10-21T12:55:59","guid":{"rendered":"https:\/\/blogdelarechercheclinique.com\/?p=1357"},"modified":"2024-05-23T10:32:46","modified_gmt":"2024-05-23T08:32:46","slug":"les-ich-sur-le-bout-des-doigts","status":"publish","type":"post","link":"https:\/\/blogdelarechercheclinique.com\/en\/les-ich-sur-le-bout-des-doigts\/","title":{"rendered":"The ICH E6 (R2) on the fingertips"},"content":{"rendered":"
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The ICH on the fingertips<\/strong><\/p>\n

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\u00a0the document was updated? If you knew, great! If not, it’s still time to catch up.<\/p>\n

\"ICH<\/p>\n

Do not worry, it is currently a draft version of the \u00ab\u00a0ICH E6 R2\u00a0\u00bb addendum to the Guidelines on GCP (= Good Clinical Practice).<\/em> It is a \u00ab\u00a0draft\u00a0\u00bb 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.<\/p>\n

1. The Investigator<\/h2>\n

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\u00a0integrity carried out by his team and the data generated, considering\u00a0the evolution and the increasing\u00a0use of technology and computerized systems.<\/p>\n

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.<\/p>\n

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.<\/p>\n

2. The Promoter<\/h2>\n

The biggest change in this version of ICH is the addition of a \u00ab\u00a0Quality management\u00a0\u00bb 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 \u00ab\u00a0risk\u00a0\u00bb to manage them if they arise. You can read\u00a0here<\/a>\u00a0the article that was written about it on the blog.<\/em><\/p>\n

Remember, the risks must be:<\/p>\n