{"title":"Translating a Culture of Quality to Clinical Research Conduct: Expanding the Clinical Development Quality Framework.","authors":"Michael Torok, Leslie Sam, Jennifer Hebert","doi":"10.1007/s43441-023-00610-5","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":null,"pages":null},"PeriodicalIF":2.0000,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11043139/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic innovation & regulatory science","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s43441-023-00610-5","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/2/7 0:00:00","PubModel":"Epub","JCR":"Q4","JCRName":"MEDICAL INFORMATICS","Score":null,"Total":0}
引用次数: 0
Abstract
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.
期刊介绍：
Therapeutic Innovation & Regulatory Science (TIRS) is the official scientific journal of DIA that strives to advance medical product discovery, development, regulation, and use through the publication of peer-reviewed original and review articles, commentaries, and letters to the editor across the spectrum of converting biomedical science into practical solutions to advance human health.
The focus areas of the journal are as follows:
Biostatistics
Clinical Trials
Product Development and Innovation
Global Perspectives
Policy
Regulatory Science
Product Safety
Special Populations
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