Quality Assurance for Cardiac Transplant Patient Phenotypic and Demographic Data:
Quality Assurance for the patient demographic and physiologic profile is intrinsic in the Standard Operating Procedure (SOP) for data collection and analysis. (Detailed descriptions of the protocol appear on the Human Cardiac Organ Bank Website).
The phenotyping component of the human cardiac organ bank project of the Cardio-Genomics PGA provides 153 phenotypic and demographic measurements of heart, function and previous drug therapy. The data provides the functional information required to link the gene expression profile with heart function.
All protocols for the collection of phenotypic data have been reviewed and approved by the Committee for the protection of human subjects at the Brigham and Women’s Hospital and Harvard Medical School. In general fully trained Anesthesiologists and Cardiologists collect all phenotypic data. Each data point is certified by one of the 3 co-investigators. This is accomplished in two stages. First, Drs. Allen, Maddi, Body, and Castillo enter the data directly into the PGA web based data entry form. They also meet monthly to review data. When all conflicts are resolved and the minimum number of values is achieved, the data are posted to the Cardio-Genomics Website. Data posting is on a quarterly basis.
Participants
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