Current Trends in Quality Assurance of Clinical Research
Clinical Research is an
investigation in humans anticipated to decide or confirm the effects of a drug
or to identify any adverse reactions with an intention of ascertaining its
safety and efficacy. Quality of clinical Research relies on data consistency
and subject safety. Quality control and quality assurance are part of quality
management systems. There is an increasing focus on having quality systems in
place throughout the planning stages of clinical Research. The regulatory
outline for clinical Research has altered in recent years with the addition of
thorough controls to guarantee patient protection and data dependability. There
is a clear requisite to execute the principles of planned quality management in
health research to avoid failure, take full advantage of the utilization of
offered resources and guarantee reliability and integrity of results. Ideally,
all clinical Research ought to have a Clinical Research Quality Management Plan
(CRQMP) describing the tools that will be used to guarantee study quality.
Adoption of quality-by-design (QbD) and quality risk management methods for
clinical Research management is the current mantra at FDA.
Quality by Design,
Quality Management System, Quality assurance, Good clinical Practice.
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Bhatt: Quality of clinical Research: A moving target. Perspectives in Clinical
Research. 2011. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3227329/
Leishman, F. Hoffmann: Quality by Design in Clinical Projects If you keep on
doing what you always did http://www.chiltern.com/pdf/customers/Chiltern%20v2-%20QRM.pdf.
Research Transformation Initiative (CTTI): Conducting Multicenter Clinical
Research: New Recommendations and Tool for Research. https://www.ctti-clinicalResearch.org/.
of Federal Regulations Title 21. US Food and Drug Administration, Department of
Health and Human Services. Subchapter D: drugs for human use. Investigational
New Drug Application Subpart D—responsibilities of sponsors and investigators.
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the globalization of clinical research. N Engl JMed 2009; 360:816-823
Sheet Guidance for IRBs, Clinical Investigators, and Sponsors FDA Inspections
of Clinical Investigators. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126553.pdf.
PEK, Marjorie AS, Reviewing Clinical Research: A Guide for the Ethics
Committee. March 2010. www.pfizer.com/files
CF, Ball LK: Building quality in clinical Research with use of a quality
systems approach. http://cid.oxfordjournals.org/content/51/Supplement_1/S111.full.
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A. Quality assurance in EORTC clinical Research. European Organisation for
Research and Treatment of Cancer. Eur J Cancer 2002; 38(Suppl 4):S159-S161
J: Educating and training CRAs for the field. Monitor. 2011:32–5.
P, Van Horn R: The contract research organization and the commercialization of
scientific research. Soc Stud Sci 2005; 35:503-548.
BW, Cochran CJ, White JG, Harley J, Kleppinger CF, Liu A, et al: Monitoring the
quality of conduct of clinical Research: A survey of current practices.
ClinResearch. 2011; 8:342–9.
Research and Manufacturers of America. White paper on acceptable approaches for
clinical Research monitoring. Office of Scientific and Regulatory Affairs;
for an FDA medical Device Sponsor Inspection. http://www.fda.gov/downloads/Training/CDRHLearn/UCM176843.pdf.
Assurance and Educational Standards for Clinical Research Sites. J Oncol
Practice 2008; 4(6):280–282. http://jop.ascopubs.org/content/4/6/280.full?sidpa9e414cd-8327-47cc-87aa-89959172e375.
Research needs quality
management. Article, quality management. http://www.therqa.com/assets/js/tiny_mce/plugins/filemanager/files/Committees/Quality/Research_needs_quality_manag
Yafit: Clinical Quality by Design (QbD) & the Critical Path. May 2010. http://apps.pharmacy.wisc.edu/esp/prog/IsraelQBD/handouts/Starck%20Yafit.pdf.
Sina Djali, MS: How a
Data-Driven Quality Management System Can Manage Compliance Risk in Clinical
Research. Drug Information Journal, Vol. 44, pp. 359–373, 2010 •
Wechsler: Central vs.
local: rethinking IRBs. Applied Clinical Research Online 2007. http://appliedclinicalResearchonline.findpharma.com/appliedclinicalResearch/Regulatory+Articles/Central-vs-Local-Rethinking-IRBs/ArticleStandard/Article/detail/401619.