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“ALCOA”: ELEMENTS OF GOOD DOCUMENTATION

Research Compliance and Integrity Tel: 858 822-4939 / Email: X:\ORA\RESEARCH COMPLIANCE\EDUCATION\Fact Sheets\ALCOA Standards ALCOA ELEMENTS of Good DOCUMENTATION Issued: March 2021 ALCOA : ELEMENTS OF GOOD DOCUMENTATION Thorough DOCUMENTATION is vital to ensure compliance with federal and state laws as well as institutional policies related to the conduct of research. The Food and Drug Administration (FDA) first introduced the ALCOA concept, Attributable, Legible, Contemporaneous, Original, and Accurate, as the fundamental principles of data quality that research DOCUMENTATION must meet. The International Council for Harmonization (ICH) E6(R2) addendum for Good Clinical Practices further added the Complete principle to ALCOA. Thorough DOCUMENTATION in research allows for the reconstruction of the research as it happened.

of the acronym ALCOA apply to both paper and electronic source data, and the records that hold that data. The degree to which the data fulfills the data quality criteria establishes the acceptability of the data. The table below describes all elements of ALCOA-C. Attributable The raw data is traceable to authorized person recording the data

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