THE HERITAGE FAMILY STUDY - QUALITY ASSURANCE AND QUALITY-CONTROL

The HERITAGE (HEalth, RIsk factors, exercise Training And GEnetics) Fa mily Study is the first multicenter family clinical trial of its kind. Conducted by a consortium of five universities in the United States a nd Canada, the study has as its primary goal to document the role of t he genotype in the cardiovascular, metabolic, and hormonal responses t o aerobic exercise training. A comprehensive protocol was implemented at four Clinical Centers (CC) for the generation of data on sedentary subjects. This group included 450 caucasians from 90 nuclear families (father, mother, three children) and 200 black subjects from 40 to 100 family units over a 5-year period. The entire family was tested befor e and after a 20-week exercise training program. The fifth participati ng center, the Data Coordinating Center (DCC), is responsible for data management and data analysis. A Consortium Coordinating Center (CCC) responsible for the overall coordination and direction of the study wa s established at the Quebec CC. Quality assurance and quality control are jointly coordinated by the CCC and the DCC. A multicenter study of this magnitude requires careful standardization of all procedures and constant monitoring of quality control at all levels of operation. Th is report describes the quality assurance and quality control measures implemented in the HERITAGE Family Study, including some examples wit h real data. (C) 1996 by Elsevier Science Inc.