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  2. Good clinical practice - Wikipedia

    en.wikipedia.org/wiki/Good_clinical_practice

    A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.

  3. Good Clinical Practice Directive - Wikipedia

    en.wikipedia.org/wiki/Good_Clinical_Practice...

    The Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005 of the European Parliament and of the Council) lays down principles and detailed guidelines for good clinical practice as regards conducting clinical trials of medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.

  4. Good laboratory practice - Wikipedia

    en.wikipedia.org/wiki/Good_Laboratory_Practice

    The Principles of Good Laboratory Practice (GLP) establish rules and criteria for a quality system that oversees the organizational processes and conditions in which non-clinical health and environmental safety studies are planned, conducted, monitored, recorded, reported, and archived.

  5. Medical ethics - Wikipedia

    en.wikipedia.org/wiki/Medical_ethics

    Medical ethics is an applied branch of ethics which analyzes the practice of clinical medicine and related scientific research. [1] Medical ethics is based on a set of values that professionals can refer to in the case of any confusion or conflict. These values include the respect for autonomy, non-maleficence, beneficence, and justice. [2]

  6. Declaration of Helsinki - Wikipedia

    en.wikipedia.org/wiki/Declaration_of_Helsinki

    The Declaration developed the ten principles first stated in the Nuremberg Code, and tied them to the Declaration of Geneva (1948), a statement of physicians' ethical duties. The Declaration more specifically addressed clinical research, reflecting changes in medical practice from the term 'Human Experimentation' used in the Nuremberg Code. A ...

  7. Evidence-based medicine - Wikipedia

    en.wikipedia.org/wiki/Evidence-based_medicine

    [1] [39] In 2005, Eddy offered an umbrella definition for the two branches of EBM: "Evidence-based medicine is a set of principles and methods intended to ensure that to the greatest extent possible, medical decisions, guidelines, and other types of policies are based on and consistent with good evidence of effectiveness and benefit."

  8. Good documentation practice - Wikipedia

    en.wikipedia.org/wiki/Good_documentation_practice

    Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.

  9. Clinical audit - Wikipedia

    en.wikipedia.org/wiki/Clinical_audit

    where national standards and guidelines exist; where there is conclusive evidence about effective clinical practice (i.e. evidence-based medicine). areas where problems have been encountered in practice. what patients and public have recommended that be looked at. where there is a clear potential for improving service delivery.