1.
J Pain Symptom Manage
; 6(7): 407, 1991 Oct.
Artigo
em Inglês
| MEDLINE
| ID: mdl-1940483
2.
Qual Assur
; 7(3): 135-45, 1999.
Artigo
em Inglês
| MEDLINE
| ID: mdl-11033739
RESUMO
The increasing number and complexity of clinical trials, coupled with the recent increase in attention and enforcement from the U.S. Food and Drug Administration, arguably makes it more important than ever before that clinical investigators understand the regulatory requirements with which they must comply. This article outlines some of these requirements, common areas of non-compliance and FDA's enforcement options in dealing with such non-compliance. Finally, the article provides some suggestions for attaining and managing investigator compliance.