Quality management
Quality control procedures will include a review of each clinical research form for accuracy and missing values, followed by queries to assess for missing values and consistency of responses across forms. A Johns Hopkins study coordinator will monitor the performance of all procedures to ensure they are in line with the study protocol including auditing both the abstraction and data entry processes with the purpose of identifying erroneous practices and to correct any drift in performance. Five percent of all abstracted files will be compared to their source documents for accuracy.