CR site problems may mean inadequate monitoring

June 2007
Clinical Trials Administrator;Jun2007, Vol. 5 Issue 6, p68
The article presents quality systems approach tips to solve compliance problems at clinical trial (CT) sites. Paul Below of P. Below Consulting Inc. says that the key is for sponsors and CT sites to use a quality systems approach to research. Some CR experts are suggesting that the industry move toward a quality systems approach, including consistency and standardization in dealing with problems.


Related Articles

  • Affairs of State. Wechsler, Jill // Applied Clinical Trials;Jul2001, Vol. 10 Issue 7, p22 

    Discusses policies aimed at guiding clinical studies worldwide. International Conference on Harmonisation's standards for clinical practice; World Medical Association's revision of the Declaration of Helsinki; Use of placebos in clinical studies; Disputes over protocols; Role of the...

  • Polypill trial under way. A. C. // New Zealand Doctor;8/1/2007, p5 

    The article focuses on the first Improving Adherence using Combination Therapy (IMPACT) trial investigating the use of polypill in people at high risk of cardiovascular disease. Patients from different parts of New Zealand has been screened to see if they take their medication better as a...

  • CHAPTER 26: Design Principles and Their Application in Preventive Field Trials. Brown, C. Hendricks // Handbook of Drug Abuse Prevention: Theory, Science, & Practice;2003, p523 

    The article provides a framework for assessing the quality of a preventive field trial. Such a framework is useful for three purposes. First, research scientists can direct their attention to a limited number of essential elements in designing and implementing new preventive trials. Second,...

  • CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Schulz, Kenneth F.; Altman, Douglas G.; Moher, David // BMJ: British Medical Journal (Overseas & Retired Doctors Edition;3/27/2010, Vol. 340 Issue 7748, p698 

    The article offers information on the Consolidated Standards of Reporting Trials (CONSORT) 2010, an updated guidelines for reporting parallel group randomized trials in Great Britain. The purpose of the CONSORT 2010 is elaborated. It traces the origins of CONSORT, beginning from the first...

  • Clinical Trial Registration: The Differing Views of Industry, the WHO, and the Ottawa Group. Krleža-Jerić, Karmela // PLoS Medicine;Nov2005, Vol. 2 Issue 11, p1093 

    The article reports on the launching of the International Clinical Trials Registry Platform project by the World Health Organization (WHO) in an effort to develop worldwide standards of trial registration. Many registries have been developed to meet various specific needs. Several members of...

  • The pursuit of unbiased research: randomized controlled trials. Schulz, Kenneth F. // Contemporary OB/GYN;Feb2000, Vol. 45 Issue 2, p48 

    Focuses on randomized controlled trial in medical research. Discussion on randomization; Benefits of randomization; Nonrandomized comparisons and bias.

  • Determination of the Clinical Importance of Study Results. Man-Son-Hing, Malcolm; Laupacis, Andreas; O'Rourke, Keith; Molnar, Frank J.; Mahon, Jeffery; Chan, Karen B. Y.; Wells, George // JGIM: Journal of General Internal Medicine;Jun2002, Vol. 17 Issue 6, p469 

    Formal statistical methods for analyzing clinical trial data are widely accepted by the medical community. Unfortunately, the interpretation and reporting of trial results from the perspective of clinical importance has not received similar emphasis. This imbalance promotes the historical...

  • Work Practice Guides. Zehrer, Cindy // Applied Clinical Trials;May2001, Vol. 10 Issue 5, p70 

    Focuses on work practice guides in clinical research. Promotion of clinical research best practices; Fostering of consistency within the clinical group.

  • Notes from the field. Hellsten, Donna // Applied Clinical Trials;May2001, Vol. 10 Issue 5, p78 

    Focuses on the use of computers in clinical research. Electronic data capture; Questions to ask prospective vendors.


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics