What types of quality control were built into the study?
To insure integration of process across institutions, at the beginning of the project we created Standard Operating Procedures (SOPs) and planned and conducted Quality Assurance/Quality Control visits on a periodic basis. Weekly conference calls were held throughout the course of the study to monitor adherence with study procedures and to assess milestones. A few times a year, in person site visits were conducted where laboratory, data storage facilities, and hospitals were visited and meetings where conducted with key personnel. When necessary, special meetings were arranged to deal with problems, occasionally by video conference. Site visits often included scientific presentations. Monthly and annual reports were reviewed. Study progress was also reported to a group of investigators from the Division of Cancer Epidemiology and Genetics of NCI that assessed study activity and recommended technical, scientific or management changes when appropriate. Detailed study manuals covering proc
