... review them Manufacturing Project manager, software manager, and data manager Cross-functional review and approval by biostatistics, CRMs, and medical affairs Design team, medical manager, and medical ... three ways: Enter directly at each physician’s computer Transfer the data automatically at day’s end via telephone to the central database Copy the data each day to a CD; at the end of the week the ... your approval Thereafter, all decisions as to access to the data will be yours alone Maintaining an Audit Trail To avoid even the appearance of fraud, and to satisfy government regulations, all...