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

שמור ב:

מידע ביבליוגרפי
מחבר ראשי:	Liu, Margaret B.
מחבר תאגידי:	Duke Clinical Research Institute
מחברים אחרים:	Davis, Kate (Kate G.)
פורמט:	ספר
שפה:	English
יצא לאור:	Chichester, West Sussex, UK ; Hoboken, NJ : Wiley-Blackwell, 2010.
מהדורה:	2nd ed.
נושאים:	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.
גישה מקוונת:	Publisher description Table of contents only Contributor biographical information
תגים:	הוספת תג אין תגיות, היה/י הראשונ/ה לתייג את הרשומה!

תוכן הענינים:

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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