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  2. Good clinical practice - Wikipedia

    en.wikipedia.org/wiki/Good_clinical_practice

    In drug development and production, good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and ...

  3. 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. While some GDocP standards are codified by various competent authorities, others ...

  4. Belmont Report - Wikipedia

    en.wikipedia.org/wiki/Belmont_Report

    The Belmont Report is a 1978 report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.Its full title is the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

  5. Declaration of Helsinki - Wikipedia

    en.wikipedia.org/wiki/Declaration_of_Helsinki

    Declaration of Helsinki. The Declaration of Helsinki (DoH, Finnish: Helsingin julistus) is a set of ethical principles regarding human experimentation developed originally in 1964 for the medical community by the World Medical Association (WMA). [1] It is widely regarded as the cornerstone document on human research ethics. [1][2][3][4]

  6. Clinical research coordinator - Wikipedia

    en.wikipedia.org/wiki/Clinical_research_coordinator

    Clinical research coordinator. A Clinical Research Coordinator (CRC) is a person responsible for conducting clinical trials using good clinical practice [1] (GCP) under the auspices of a Principal Investigator (PI). Good clinical practices principles have been defined by Madelene Ottosen, RN, MSN, of The University of Texas Health Science ...

  7. Evidence-based nursing - Wikipedia

    en.wikipedia.org/wiki/Evidence-based_nursing

    Evidence-based nursing (EBN) is an approach to making quality decisions and providing nursing care based upon personal clinical expertise in combination with the most current, relevant research available on the topic. This approach is using evidence-based practice (EBP) as a foundation. EBN implements the most up to date methods of providing ...

  8. Trial master file - Wikipedia

    en.wikipedia.org/wiki/Trial_master_file

    A trial master file contains essential documents for a clinical trial that may be subject to regulatory agency oversight. In the European Union (EU), TMFs have a different definition and set of requirements than in the US. The EU Commission's Directive 2005/28/EC 63 Chapter 4 states 'the trial master file shall consist of essential documents ...

  9. Nursing theory - Wikipedia

    en.wikipedia.org/wiki/Nursing_theory

    Nursing theory is defined as "a creative and conscientious structuring of ideas that project a tentative, purposeful, and systematic view of phenomena". [1] Through systematic inquiry, whether in nursing research or practice, nurses are able to develop knowledge relevant to improving the care of patients. Theory refers to "a coherent group of ...