title: Comprehensive Quality Management (CQM) in the PLCO Trial.
abstract: The NCI imbedded the notion of comprehensive quality control and assurance (CQA) in the design concept for the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial. PLCO implemented a comprehensive, adaptable quality assurance and control program to span more than 20 years of data collection, coordinate multiple institutions and committees, and integrate a wide variety of complex protocols. CQA concepts, practices, and procedures traced through all aspects of trial management, governance, and operations of PLCO. The driving force behind CQA in PLCO was scientific and clinical credibility of trial data and findings. CQA as implemented in PLCO was operationally analogous to the concept of Total Quality Management (TQM) described in the management literature. This paper describes CQA actualization in PLCO.
authors.affiliation: Office of Disease Prevention, Office of the Director, National Institutes of Health, 6100 Executive Blvd. Ste. 2B03. Rockville, MD 20892, USA. jg72p@nih.gov.
authors.forename: John K
authors.initials: JK
authors.lastname: Gohagan
authors.forename: Barbara
authors.initials: B
authors.lastname: O'Brien
authors.forename: Marsha A
authors.initials: MA
authors.lastname: Hasson
authors.forename: Keith D
authors.initials: KD
authors.lastname: Umbel
authors.forename: Beth
authors.initials: B
authors.lastname: Bridgeman
authors.forename: Barnett S
authors.initials: BS
authors.lastname: Kramer
authors.forename: Douglas
authors.initials: D
authors.lastname: Reding
authors.forename: Lisa
authors.initials: L
authors.lastname: Gren
authors.forename: Patrick
authors.initials: P
authors.lastname: Wright
authors.forename: Thomas
authors.initials: T
authors.lastname: Riley
authors.forename: Philip C
authors.initials: PC
authors.lastname: Prorok
mesh_terms: D015179:Colorectal Neoplasms / Q000175:diagnosis / Q000517:prevention & control; D055088:Early Detection of Cancer / Q000592:standards*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000175:diagnosis / Q000517:prevention & control; D008297:Male; D008403:Mass Screening / Q000458:organization & administration; D015337:Multicenter Studies as Topic; D009369:Neoplasms / Q000175:diagnosis* / Q000517:prevention & control; D010051:Ovarian Neoplasms / Q000175:diagnosis / Q000517:prevention & control; D011471:Prostatic Neoplasms / Q000175:diagnosis / Q000517:prevention & control; D011785:Quality Assurance, Health Care; D011786:Quality Control; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D014481:United States