Medical Writing Regulatory Writing Basics Good clinical practice (GCP): A universal call for ethics in biomedical research
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Volume 23, Issue 2 - Regulatory Writing Basics

Good clinical practice (GCP): A universal call for ethics in biomedical research

Abstract

Today, the principles of good clinical practice (GCP) form such an integral part of the development of new medicines that they could easily be taken for granted. Yet, the road to a universal code of ethics in human experimentation is paved with tragedies which have only gradually led to tightened rules on human experimentation. Awareness of the historical roots of GCP helps explain that GCP, rather than representing a seemingly endless series of regulations, finally provides an international ethical and scientific quality standard designed to protect the rights and safety of individuals consenting to participate in clinical trials and to ensure the integrity and credibility of clinical research data. For medical writers, familiarity with the principles of GCP, which in the European Union are now a legal obligation, is an essential prerequisite for providing documentation in compliance with the ethical and scientific principles of GCP: not only are medical writers expected to frame clinical research into a language that enables independent assessors to evaluate the methodological validity of a study and the safety and efficacy of a given drug, they also compose documents that may be instrumental in assuring the rights and safety of clinical trial participants.

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