Current Trends in Quality Assurance of Clinical Research

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Authors : Boyina Chaya Devi, Ramesh C


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.


1.      Allen Jean Toth: Building quality into clinical Research- an FDA perspective. May 14, 2012.

2.      A Guided Self-Assessment for Human Research Protection Programs

3.      Ann Meeker-O’Connell: Enhancing Clinical Research Quality: CDER Perspective.

4.      Ajay S, Bhatt A: Knowledge and skills at the study site - requirements for clinical research professionals in India: A Survey. CR Focus. 2008; 19:36–9.

5.      American Society for Quality. Project planning and implementing tools.

6.      Arun Bhatt: Quality of clinical Research: A moving target. Perspectives in Clinical Research. 2011.

7.      Barbara Leishman, F. Hoffmann: Quality by Design in Clinical Projects If you keep on doing what you always did

8.      Clinical Research Transformation Initiative (CTTI): Conducting Multicenter Clinical Research: New Recommendations and Tool for Research.

9.      Code 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. Sec. 312.50. General responsibilities of sponsors.

10.  Duley L, Antman K, Arena J, et al: Specific barriers to the conduct of randomized Research. Clin Research 2008; 5:40-48

11.  Eisenstein EL, Collins R, Cracknell BS, et al: Sensible approaches for reducing clinical Research costs. Clin Research 2008; 5:75-84.

12.  FDA ORA Quality Manual.

13.  Glickman SW, McHutchison JG, Peterson ED, et al: Ethical and scientific implications of the globalization of clinical research. N Engl JMed 2009; 360:816-823

14.  Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors FDA Inspections of Clinical Investigators.

15.  Johan PEK, Marjorie AS, Reviewing Clinical Research: A Guide for the Ethics Committee. March 2010. /research/...Research/ethics_committee guide.pdf.

16.  Kleppinger CF, Ball LK: Building quality in clinical Research with use of a quality systems approach.

17.  Lewis DD, Yang Y, Rose T, Li F. A new benchmark collection for text categorization research. J Ma-chine Learn Res. 2004; 5:361–397.

18.  Loff B, Black J: Research ethics committees: What is their contribution? Med J Aust. 2004; 181:440–1.

19.  Marinus A. Quality assurance in EORTC clinical Research. European Organisation for Research and Treatment of Cancer. Eur J Cancer 2002; 38(Suppl 4):S159-S161

20.  Matzat J: Educating and training CRAs for the field. Monitor. 2011:32–5.

21.  Mirowski P, Van Horn R: The contract research organization and the commercialization of scientific research. Soc Stud Sci 2005; 35:503-548.

22.  Morrison 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.

23.  Pharmaceutical Research and Manufacturers of America. White paper on acceptable approaches for clinical Research monitoring. Office of Scientific and Regulatory Affairs; March 2009.

24.  Preparing for an FDA medical Device Sponsor Inspection.

25.  Quality Assurance and Educational Standards for Clinical Research Sites. J Oncol Practice 2008; 4(6):280–282.

26.  Research needs quality management. Article, quality management. emeny_system.pdf.

27.  Stark Yafit: Clinical Quality by Design (QbD) & the Critical Path. May 2010.

28.  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 • 0092-8615/2010.


30.  Wechsler: Central vs. local: rethinking IRBs. Applied Clinical Research Online 2007.