Good Clinical Practice: A Question & Answer Reference Guide - May 2014 - 543

GCP and Clinical Research Standards in the European Union
Although these documents do not have legal force, they reflect the current thinking of EMA and the NCAs (National
Competent Authorities), and as such should be taken duly into consideration by sponsors.
18.2 Q. What is the EU's definition of good clinical practice?
A. Rather than a single definition, the sequential nature of EU legislation has led instead to an accumulation
of definitions. According to the 2001 clinical trials directive, "Good clinical practice is a set of internationally
recognized ethical and scientific quality requirements which must be observed for designing, conducting, recording
and reporting clinical trials that involve the participation of human subjects. Compliance with this good practice
provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the
clinical trials are credible . . . The principles of good clinical practice and detailed guidelines in line with those
principles shall be adopted and, if necessary, revised to take account of technical and scientific progress." The
directive adds that, "All clinical trials, including bioavailability and bioequivalence studies, shall be designed,
conducted and reported in accordance with the principles of good clinical practice."
The clinical trials directive also states that, "The accepted basis for the conduct of clinical trials in humans is
founded in the protection of human rights and the dignity of the human being with regard to the application of
biology and medicine, as for instance reflected in the 1996 version of the Helsinki Declaration. The clinical trial
subject's protection is safeguarded through risk assessment based on the results of toxicological experiments prior
to any clinical trial, screening by ethics committees and member states' competent authorities, and rules on the
protection of personal data."
Building on this, the 2005 GCP directive specifies that:
* The rights, safety and well-being of the trial subjects shall prevail over the interests of science and society.
* Each individual involved in conducting a trial shall be qualified by education, training, and experience to
perform his/her tasks.
* Clinical trials shall be scientifically sound and guided by ethical principles in all aspects.
* The necessary procedures to secure the quality of every aspect of the trials shall be complied with.
* The available non-clinical and clinical information on an investigational medicinal product shall be adequate
to support the proposed clinical trial.
* Clinical trials shall be conducted in accordance with the Declaration of Helsinki on Ethical Principles for
Medical Research Involving Human Subjects, adopted by the General Assembly of the World Medical
Association (1996).
* The protocol shall provide for the definition of inclusion and exclusion criteria for the clinical trial, monitoring
and publication policy.
* The investigator and sponsor shall consider all relevant guidance with respect to commencing and conducting
a clinical trial.
* All clinical trial information shall be recorded, handled, and stored in such a way that it can be accurately
reported, interpreted and verified, while the confidentiality of trial subjects' records remains protected.
18.3 Q. Since the 2001 clinical trials directive establishes that "all clinical trials" must comply with GCP
standards, what is the relevant EU definition of a clinical trial?
A. The 2001 clinical trials directive says a clinical trial is "any investigation in human subjects intended to discover
or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational
medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s)
and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal
product(s) with the object of ascertaining its (their) safety and/or efficacy. This includes clinical trials carried out
in either one site or multiple sites, whether in one or more than one member state." A multi-centre clinical trial
is defined as "a clinical trial conducted according to a single protocol but at more than one site, and therefore by
more than one investigator, in which the trial sites may be located in a single member state, in a number of member
states and/or in member states and third countries." The directive also notes that bioavailability and bioequivalence
trials are subject to GCP rules, and that these analytical laboratory assessments must comply with the "principles
of GLP." The new Clinical Trials Regulation is refining the above definitions; however, until this becomes effective
(foreseen for mid 2016) the requirements of the 2001 Directive continue to apply.
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