PRINCIPLES OF ICH GCP
Clinical trials should be conducted in accordance with the ethical
principles that have their origin in the Declaration of Helsinki,
and that are consistent with GCP and the applicable regulatory requirement(s).
Before a trial is initiated, foreseeable risks and inconveniences
should be weighed against the anticipated benefit for the individual
trial subject and society. A trial should be initiated and continued
only if the anticipated benefits justify the risks.
The rights, safety, and well-being of the trial subjects are the most
important considerations and should prevail over interests of science
The available nonclinical and clinical information on an investigational
product should be adequate to support the proposed clinical trial.
Clinical trials should be scientifically sound, and described in a
clear, detailed protocol.
A trial should be conducted in compliance with the protocol that has
received prior institutional review board (IRB)/independent ethics
committee (IEC) approval/favourable opinion.
The medical care given to, and medical decisions made on behalf of,
subjects should always be the responsibility of a qualified physician
or, when appropriate, of a qualified dentist.
Each individual involved in conducting a trial should be qualified
by education, training, and experience to perform his or her respective
Freely given informed consent should be obtained from every subject
prior to clinical trial participation.
All clinical trial information should be recorded, handled, and stored
in a way that allows its accurate reporting, interpretation and verification.
The confidentiality of records that could identify subjects should
be protected, respecting the privacy and confidentiality rules in
accordance with the applicable regulatory requirement(s).
Investigational products should be manufactured, handled, and stored
in accordance with applicable good manufacturing practice (GMP). They
should be used in accordance with the approved protocol.
Systems with procedures that assure the quality of every aspect of
the trial should be implemented.