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Quality Tolerance Limits: A General Guidance for Parameter Selection and Threshold Setting.
Ther Innov Regul Sci. 2024 May;58(3):423-430. doi: 10.1007/s43441-024-00617-6. Epub 2024 Feb 6.
Ther Innov Regul Sci. 2024.
PMID: 38321191
Risk-Based Monitoring in Clinical Trials: Increased Adoption Throughout 2020.
Stansbury N, Barnes B, Adams A, Berlien R, Branco D, Brown D, Butler P, Garson L, Jendrasek D, Manasco G, Ramirez N, Sanjuan N, Worman G, Adelfio A.
Stansbury N, et al. Among authors: jendrasek d.
Ther Innov Regul Sci. 2022 May;56(3):415-422. doi: 10.1007/s43441-022-00387-z. Epub 2022 Mar 2.
Ther Innov Regul Sci. 2022.
PMID: 35235192
Free PMC article.
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Risk-Based Monitoring in Clinical Trials: Past, Present, and Future.
Barnes B, Stansbury N, Brown D, Garson L, Gerard G, Piccoli N, Jendrasek D, May N, Castillo V, Adelfio A, Ramirez N, McSweeney A, Berlien R, Butler PJ.
Barnes B, et al. Among authors: jendrasek d.
Ther Innov Regul Sci. 2021 Jul;55(4):899-906. doi: 10.1007/s43441-021-00295-8. Epub 2021 Apr 29.
Ther Innov Regul Sci. 2021.
PMID: 33914298
Free PMC article.
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Analysis of professional competencies for the clinical research data management profession: implications for training and professional certification.
Zozus MN, Lazarov A, Smith LR, Breen TE, Krikorian SL, Zbyszewski PS, Knoll SK, Jendrasek DA, Perrin DC, Zambas DN, Williams TB, Pieper CF.
Zozus MN, et al. Among authors: jendrasek da.
J Am Med Inform Assoc. 2017 Jul 1;24(4):737-745. doi: 10.1093/jamia/ocw179.
J Am Med Inform Assoc. 2017.
PMID: 28339721
Free PMC article.
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