Managing data in surgical trials: a guide to modern-day data management systems.
Data management is the strategy that is used for collecting, organizing, and managing data within an organization. Clinical data management plays a key part in the success of any clinical trial. The use of technology and computerized systems in the conduct of clinical trials has increased over the years and is now mainstream. The United States Food and Drug Administration has established requirements to ensure that electronic records and electronic signatures are trustworthy and reliable. Critical to the success of a data management protocol are the experienced members of the data management team. We review common aspects of data management and management systems.
Division of Orthopaedic Surgery, Department of Surgery, McMaster University, 293 Wellington Street North, Suite 110, Hamilton, Ontario L8L 8E7, Canada.
Paljinder
P
Bhatti
Emil H
EH
Schemitsch
Mohit
M
Bhandari
D003628:Database Management Systems; D057286:Electronic Health Records; D006801:Humans; D019451:Information Management / Q000458:organization & administration*; D019637:Orthopedic Procedures; D011786:Quality Control; D011873:Radiology Information Systems; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D014481:United States