J. Scribante et al., GOOD CLINICAL RESEARCH PRACTICE - WHAT IS IT AND IS IT POSSIBLE IN THE INTENSIVE-CARE UNIT, Anaesthesia and intensive care, 26(5), 1998, pp. 568-574
Citations number
10
Categorie Soggetti
Anesthesiology,"Emergency Medicine & Critical Care
With the growing quest for answers to vexing dilemmas in critically il
l patients, more intensive care units are embarking on clinical resear
ch. This places increasing importance on Good Clinical Research Practi
ce (GCRP), a set of guidelines drawn up by the Pharmaceutical Industry
to assist investigators in conducting ethical, reliable scientific st
udies. GCRP is a combination of good basic management skills allied to
ethical principles for scientific research. Based on the principles o
f the Declaration of Helsinki, it consists of three tenets: patient pr
otection (ethics), credible darn (science) and data control. This arti
cle describes GCRP specifically, relating it to the intensive care sit
uation, illustrating some of the concepts with practical examples, Wit
h a minimum of extra time and effort these basic principles can be int
egrated as routine into all research projects.