FDA draft guidance on computerised systems used in clinical trials.
When using computer systems to manage clinical studies, it is important to understand how these systems should be controlled and, for studies intended to support United States (US) regulatory submissions, when and how US regulations on electronic records and signatures apply. This article discusses these issues and a draft guidance document.
Donawa
Maria E
ME
Donawa & Associates Ltd, Rome, Italy. medonawa@donawa.com
D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards; D016494:Computer Security / Q000331:legislation & jurisprudence* / Q000592:standards; D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards; D017408:Guidelines as Topic; D016247:Information Storage and Retrieval / Q000331:legislation & jurisprudence* / Q000592:standards; D016347:Medical Records Systems, Computerized / Q000331:legislation & jurisprudence* / Q000592:standards; D014481:United States