The advent and evolution of electronic medical record over the past 20 years have brought both solutions and challenges to the conduct of clinical research. Allen Kindman and Phil Galtry of Quintiles and Mary D’Rozario of Clinical Research Performance Inc. outline the reasons why the rigour of clinical trials involving surgical procedures has lagged behind those involving pharmaceuticals. Regulatory guidance is in place to help manage the ethical concerns and a number of methods, albeit imperfect, exist for blinding subjects to their assignment.