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2. THE 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).

2. The Principles of ICH GCP

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The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed originally in 1964 for the medical community by the World Medical Association (WMA).

2. THE PRINCIPLES OF ICH GCP

SUBJECTS

SCIENTIFIC
ASPECT

Before a trial is initiated, foreseeable risks and inconveniences should be ...

QUALIFIED
PERSONNEL

The available nonclinical and clinical information on an investigational product should be ...

QUALITY

The medical care given to, and medical decisions made on behalf of, ...

All clinical trial information should be recorded, handled, and ...

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  • 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 and society.
  • A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favorable opinion.
  • Freely given informed consent should be obtained from every subject prior to clinical trial participation.
  • 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).

  • 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 and society.
  • A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favorable opinion.
  • Freely given informed consent should be obtained from every subject prior to clinical trial participation.
  • 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).

  • 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.

  • 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 task(s).

  • All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification. This principle applies to all records referenced in this guideline, irrespective of the type of media used.
  • 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. Aspects of the trial that are essential to ensure human subject protection and reliability of trial results should be the focus of such systems.

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