Name That CFR/Guidance Flashcards
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This part contains the general standards for the composition, operation, and responsibility of an IRB that reviews clinical investigations regulated by the FDA.
21 CFR Part 56
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An international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.
International Conference on Harmonization (ICH) Good Clinical Practice (GCP)
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The criteria in which the FDA considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.
21 CFR Part 11
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Provides a unified standard for the European Union, Japan, and the US to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions
International Conference on Harmonization (ICH) Good Clinical Practice (GCP)
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This part applies to research involving drugs, medical devices, biological products for human use (all clinical investigations regulated by the FDA). Intended to protect the rights and safety of subjects involved in investigations filed with the FDA. Includes informed consent guidance and additional safeguards for children.
21 CFR Part 50
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An international guideline that provides standard definitions and terminology for clinical safety reporting. Also offers guidance on how to handle expedited reporting of adverse drug reactions (ADRs) during the investigational phase of drug development.
ICH Clinical Safety Data Management: Definitions and Standards for Expedited Reporting E2A
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Also known as the “Common Rule,” this policy includes HHS regulations for the Protection of Human Subjects in research, providing a robust set of protections for research subjects. Includes procedures for IRBs, and additional protections for pregnant women, fetuses, neonates, prisoners, and children involved in research.
45 CFR Part 46
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This part provides procedures for the conduct of clinical investigations of devices. An approved IDE permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device.
21 CFR Part 812
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This part contains procedures and requirements governing the use of investigational new drugs, including
procedures and requirements for the submission to, and review by, the FDA IND’s.
21 CFR Part 312
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Focuses on increasing human subject protections and data integrity mainly through better study design and conduct. Mostly affects the Sponsor.
The ICH E6(R2) integrated addendum
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A statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects (Ethical Principles and Guidelines for the Protection of Human Subjects of Biomedical and Behavioral Research)
Belmont Report 1974
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Is the basis for the Declaration of Helsinki
Nuremberg Code 1947
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A set of 10 research principles focused on the protection of subjects’ human rights, with voluntary informed consent at its core
Nuremberg Code 1947
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Developed as a result of the trial regarding “medical experiments” conducted by German physicians and administrators during WWII in thousands of prisoners without their consent
Nuremberg Code 1947
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A statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data, addressed primarily to physicians
Declaration of Helsinki 1964
