A clinical trials manual from the Duke Clinical Research Institute : lessons from a horse named Jim /

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Bibliografiska uppgifter
Huvudupphovsman:	Liu, Margaret B.
Institutionell upphovsman:	Duke Clinical Research Institute
Övriga upphovsmän:	Davis, Kate (Kate G.)
Materialtyp:	Bok
Språk:	English
Publicerad:	Chichester, West Sussex, UK ; Hoboken, NJ : Wiley-Blackwell, 2010.
Upplaga:	2nd ed.
Ämnen:	Clinical trials > Handbooks, manuals, etc. Drugs > Testing > Handbooks, manuals, etc. Clinical Trials as Topic > legislation & jurisprudence > United States. Clinical Trials as Topic > ethics > United States. Device Approval > United States. Drug Approval > United States.
Länkar:	Publisher description Table of contents only Contributor biographical information
Taggar:	Lägg till en tagg Inga taggar, Lägg till första taggen!

Innehållsförteckning:

Lessons from a horse named Jim and other events in history affecting the regulation of clinical research
The process : developing new drugs, biologics, and devices
Good clinical practice and the regulations
Informed consent and the regulations
Institutional review boards
Adverse events and unanticipated problems involving risks to subjects and others
Monitoring, audits, and inspections
The principal investigator, the clinical research coordinator, and the study site
The protocol
Study feasibility : reviewing a specific protocol
Study activities
Study documents/essential documents
Management of study drugs, biologics, and devices
Managing clinical trial data
Global health and international trials.

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