ICH GCP (ICH-E6)
Translation agency "MedTransservice" is specialized in the translation of medical/clinical documentation, and is the only company in Russia which managed the translation and publication of two guidelines: «ICH Harmonized Tripartite Guidelines for Good clinical Practice (ICH-E6)», and «Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A)».
Only our agency publishes an official bilingual translation of Guidelines!
What is ICH GCP (ICH-E6)?
The definition of Good Clinical Practice (GCP) is defined by International Conference on Harmonization (ICH) in the ICH E6 guideline. GCP is a standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of the subjects are protected. This standard has its origin in the Declaration of Helsinki ("Ethical Principles for Medical Research Involving Human Subjects" adopted in 1964, revised in 1973, 1985, 1989, 2013). Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the ethical principles, and that the clinical trial data are credible.
The guideline was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries, and the World Health Organization (WHO).
Since 1997 ICH GCP Guidelines should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities.
Why did we decide to translate and publish these Guidelines?
The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. As the main clients of our agency are international Pharmaceutical companies and Contract research organizations (CRO) which are presented on the Russian market of clinical trials, and the main documents our agency is dealing with and translating are clinical trial documents we decided to suggest a Russian version of the Guidelines to the wide audience of those involved in clinical research in Russia.
You have a unique opportunity to request ICH-E6 Guidelines in our agency free of charge! For this, you need just to call to our office and introduce yourself. If you have to do with clinical trials, or you represent either a Pharmaceutical company or a CRO we would be happy to give you a Booklet!