The Life Cycle and Management of Protocol Deviations.

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第一作者： Munish,Mehra

第一单位： 1 Quantum BioPharma, North Potomac, MD, USA.

作者： Munish,Mehra ^[1] ; Katharina,Kurpanek ^[2] ; Maryrose,Petrizzo ^[3] ; Sonia,Brenner ^[4] ; Yvonne,McCracken ^[5] ; Terry,Katz ^[6] ; Margaret,Gurian ^[7]

作者单位： 1 Quantum BioPharma, North Potomac, MD, USA. ^[1] 2 The QM Company, Brussels, Belgium. ^[2] 3 Halloran Consulting Group, Waltham, MA. ^[3] 4 Kyowa Hakko Kirin Pharma Inc, Princeton, NJ, USA. ^[4] 5 PMG Research, Inc., NC, USA. ^[5] 6 Merck Animal Health, Summit, NJ, USA. ^[6] 7 CompleWare Corp, North Liberty, IA USA. ^[7]

关键词 corrective action corrective action preventive action departure deviation fraud good clinical practice noncompliance preventive action professional misconduct protocol deviations protocol violations serious breach variance violation waiver

DOI 10.1177/2168479014530119

PMID 30227474

发布时间 2020-01-03

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Therapeutic innovation & regulatory science

2014年48卷6期

762-777页

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The Life Cycle and Management of Protocol Deviations.

Therapeutic innovation & regulatory science

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Therapeutic innovation & regulatory science

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The Life Cycle and Management of Protocol Deviations.

Therapeutic innovation & regulatory science

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Therapeutic innovation & regulatory science

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