European Medicines Agency (EMA) updated GCP draft published for comments

Standard

An update as an addendum to the ICH GCP E6 has been released by European Medicines Agency (EMA) for comments from the public.

ICH GCP guidelines form the basic set of guidelines which lay the foundation of ethical clinical research in all the member countries of the ICH. GCP forms the major internationally followed ethical and quality standard for the designing, recording, and reporting of human trials.

A template to file the comments has been released which needs to be emailed to ich@ema.europa.eu if you have any comments regarding the addendum to the guideline.

It is mandatory for all stakeholders of clinical research to follow the set of guidelines which provides and assurance to the public and regulatory agencies that the rights, safety and wellbeing of the trial subjects has been taken care of and that the data generated by virtue of the research is credible and acceptable internationally.

ICH GCP E6 enlists all the minimum set of responsibilities of the sponsor, monitors, Investigators and IRB/IEC in the conduct of a clinical trial.

The guideline was first implemented in 1996 and became a unified standard followed internationally. The last two decades have seen clinical trials to evolve in terms of magnitude, complexity, regulations, and cost. The information technology revolution as also affected the clinical trial industry by providing more efficient tools for risk management and trial monitoring. The concepts of risk based monitoring and central monitoring have made data management and clinical operations more efficient and cost effective.

These evolving strategies have been acknowledged by the European Medicines Agency (EMA) from time to time and now resulting in the amendment of the GCP at large. Through this amendment the EMA intends to include more efficient and enhanced approaches to clinical trial designs, study conduct, monitoring, recording, and reporting of clinical trials and further enhance the security framework around a clinical study. EMA intends to update the industry about the standards of electronic records and documentation to enhance the data integrity and overall quality and efficiency of clinical trials. In this regard several sections of the GCP document have been updated.

James Lind Institute (JLI) provides training and certification in Good Clinical Practice (GCP) guidelines. JLI also provides extensive trainings programs in Clinical Research, Pharmacovigilance, Medical and Scientific Writing, Regulatory Affairs, Pharmaceutical Medicine, Public Health Research, Tropical Medicine and Medical Journalism.

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