Clinical Trials: Rethinking How We Ensure Quality

Drug Information Journal

Volumn 46, Issue 6, 2012, Pages 657-660

  Landray, Martin J ^a   Grandinetti, Cheryl ^b   Kramer, Judith M ^c   Morrison, Briggs W ^d   Ball, Leslie ^b   Sherman, Rachel E ^b  

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^c DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d ASTRAZENECA   (United Kingdom)

Author keywords

clinical trial; good clinical practice; monitoring; quality assurance

Indexed keywords

ANALYTICAL ERROR; ARTICLE; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); DRUG MANUFACTURE; DRUG QUALITY; DRUG SURVEILLANCE PROGRAM; FEEDBACK SYSTEM; FOOD AND DRUG ADMINISTRATION; HUMAN; PRIORITY JOURNAL; PROFESSIONAL STANDARD; RISK ASSESSMENT; STATISTICAL ANALYSIS; STUDY DESIGN; SYSTEMATIC ERROR; TOTAL QUALITY MANAGEMENT;

EID: 84873827413     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/0092861512464372     Document Type: Article

References (5)

1. Califf RM.Clinical trials bureaucracy: unintended consequences of well-intentioned policy.Clin Trials. 2006;3:496-502.
2. US Food and Drug Administration. Pharmaceutical quality for the 21st century: a risk-based approach progress report. March 9, 2010. http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm128080.htm. Accessed October 1, 2012.
3. International Conference on Harmonisation (ICH)of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonised tripartite guideline: quality risk management Q9, current step 4 version (ICHQ9). November 2005. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf. Accessed October 1, 2012.
4. MorrisonBBehrmanRLandrayM; on behalf of Clinical Trials Transformation Initiative Monitoring Project. Results and recommendations: effective and efficient monitoring as a component of quality assurance in the conduct of clinical trials. May 20, 2011. https://www.ctti-clinicaltrials.org/project-topics/study-quality/effective-and-efficient-monitoring-as-a-component-of-quality/results-and-recommendations. Accessed October 1, 2012.
5. US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for Devices and Radiological Health (CDRH). Guidance for industry: oversight of clinical investigations-a risk-based approach to monitoring. August 29, 2011http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM269919.pdf. Accessed October 1, 2012.