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Research article

First published 2022-7

Establishment of risk quality control charts based on risk management strategies

Yuping Zeng, Shiyun Peng, Liye Meng [...]

Annals of Clinical Biochemistry: International Journal of Laboratory Medicine

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Research article

First published 2014-7

Key Considerations in the Transition to Risk-Based Monitoring

Michael J. Rosenberg

Therapeutic Innovation & Regulatory Science

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Research article

First published 2017-12

An evaluation of the effectiveness of a risk-based monitoring approach implemented with clinical trials involving implantable cardiac medical devices

Christopher A Diani, Angie Rock, Phil Moll

Clinical Trials

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Letter

First published 2025-6

Qualitative experience implementing an emergency department-based outpatient low-risk pulmonary embolism management pathway

S Nabeel Hyder, Valerie Gavrila, Anthony Cuttitta [...]

Vascular Medicine

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Research article

First published 2017-9

Investigation of the Factors Affecting Risk-Based Quality Management of Investigator-Initiated Investigational New-Drug Trials for Unapproved Anticancer Drugs in Japan

Tomohisa Sudo, Akihiro Sato

Therapeutic Innovation & Regulatory Science

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Research article

First published 2015-3

Advancing pharmaceutical quality oversight during the lifecycle of generic drug products

Susan M Rosencrance, Geoffrey K Wu

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

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Review article

First published 2018-9

Implementation of Question-based Review in support of Quality by Design streamlining the US FDA’s review process

Alisha Desai, Jayanta Kumar Maji, Kanhoba Walavalkar [...]

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

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Review article

First published 2025-6

Central statistical monitoring in clinical trial management: A scoping review

Maciej Fronc, Michał Jakubczyk, Sharon B Love [...]

Clinical Trials

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Other

First published 2007-5

Perspective on Quality Risk Management of Pharmaceutical Quality

H. Gregg Claycamp

Therapeutic Innovation & Regulatory Science

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Research article

First published 2009-11

Quality,risk and the Taleb quadrants

Ron S. Kenett, Charles S. Tapiero

Risk and Decision Analysis

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