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Time-consuming and expensive data quality monitoring procedures persist in clinical trials: A national survey |
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| Lauren Houston,Allison Martin,Ping Yu,Yasmine Probst |
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Clinical trial monitoring effectiveness: Remote risk-based monitoring versus on-site monitoring with 100% source data verification |
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| Osamu Yamada,Shih-Wei Chiu,Munenori Takata,Michiaki Abe,Mutsumi Shoji,Eri Kyotani,Chiyo Endo,Minami Shimada,Yuko Tamura,Takuhiro Yamaguchi |
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| Clinical Trials. 2021; 18(2): 158 |
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| Lisa Lindner,Anja Weiß,Andreas Reich,Siegfried Kindler,Frank Behrens,Jürgen Braun,Joachim Listing,Georg Schett,Joachim Sieper,Anja Strangfeld,Anne C. Regierer |
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| Arthritis Research & Therapy. 2021; 23(1) |
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Heterogeneity in clinical research data quality monitoring: a national survey |
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| Lauren Houston,Ping Yu,Allison Martin,Yasmine Probst |
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Self-audits as alternatives to travel-audits for improving data quality in the Caribbean, Central and South America network for HIV epidemiology |
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| Sarah C. Lotspeich,Mark J. Giganti,Marcelle Maia,Renalice Vieira,Daisy Maria Machado,Regina Célia Succi,Sayonara Ribeiro,Mario Sergio Pereira,Maria Fernanda Rodriguez,Gaetane Julmiste,Marco Tulio Luque,Yanink Caro-Vega,Fernando Mejia,Bryan E. Shepherd,Catherine C. McGowan,Stephany N. Duda |
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Investigation of the Factors Affecting Risk-Based Quality Management of Investigator-Initiated Investigational New-Drug Trials for Unapproved Anticancer Drugs in Japan |
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| Tomohisa Sudo,Akihiro Sato |
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| Therapeutic Innovation & Regulatory Science. 2017; 51(5): 589 |
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Efficient Source Data Verification Using Statistical Acceptance Sampling |
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| Rutger M. van den Bor,Bas J. Oosterman,Martinus B. Oostendorp,Diederick E. Grobbee,Kit C. B. Roes |
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| Therapeutic Innovation & Regulatory Science. 2016; 50(1): 82 |
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| Rasmus Olsen,Asger Reinstrup Bihlet,Faidra Kalakou,Jeppe Ragnar Andersen |
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Data-driven risk identification in phase III clinical trials using central statistical monitoring |
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| Catherine Timmermans,David Venet,Tomasz Burzykowski |
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| International Journal of Clinical Oncology. 2016; 21(1): 38 |
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Evolving quality standards for large-scale registries: the GARFIELD-AF experience |
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| Keith A.A. Fox,Bernard J. Gersh,Sory Traore,A. John Camm,Gloria Kayani,Anders Krogh,Shweta Shweta,Ajay K. Kakkar |
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| Elizabeth Nielsen,DeAnn Hyder,Chao Deng |
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Key Considerations in the Transition to Risk-Based Monitoring |
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| Michael J. Rosenberg |
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| Therapeutic Innovation & Regulatory Science. 2014; 48(4): 428 |
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| Nicole Sheetz,Brett Wilson,Joanne Benedict,Esther Huffman,Andy Lawton,Mark Travers,Patrick Nadolny,Stephen Young,Kyle Given,Lawrence Florin |
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| Therapeutic Innovation & Regulatory Science. 2014; 48(6): 671 |
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Taking the 'Risk' out of risk-based monitoring |
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| Ashwaria Gupta |
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