Translating a Culture of Quality to Clinical Research Conduct: Expanding the Clinical Development Quality Framework

被引：0

作者：

Torok, Michael ^{[1
]}

Sam, Leslie ^{[2
]}

Hebert, Jennifer ^{[3
]}

机构：

[1] Global Head Qual Assurance Programs Roche Genentec, 1 DNA Way,Suite 258A, South San Francisco, CA 94080 USA

[2] Leslie Sam & Associates, 2316 New Orchard Court, Sun City Ctr, FL 33573 USA

[3] Roche Genentech, 1 DNA Way,Suite 258A, South San Francisco, CA 94080 USA

来源：

THERAPEUTIC INNOVATION & REGULATORY SCIENCE | 2024年 / 58卷 / 03期

关键词：

Culture; Quality; Open Dialogue; Critical Thinking; MANAGEMENT-SYSTEM;

D O I：

10.1007/s43441-023-00610-5

中图分类号：

R-058 [];

学科分类号：

摘要：

The International Council on Harmonisation E8 Guidance Revision 1 (ICH E8(R1)) calls for creating a Culture of Quality that "values and rewards critical thinking and open, proactive dialogue about what is critical to quality." Across the biopharma landscape, clinical sites, sponsors, and service providers are working to translate this far-reaching guideline into working practices. This manuscript deconstructs key elements that comprise the critical thinking and open, proactive Culture of Quality "enablers." In addition, maturity models are provided so readers can visualize what a Culture of Quality looks like in their clinical research organization. These provide examples of high performing cultures of quality and useful tools for teams or organizations to measure and evolve their respective quality cultures.

引用

页码：404 / 414

页数：11

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