Physician Investigator Handbook

Regular price €235.60
A01=Deborah Rosenbaum
A01=Fred Smith
ADME
advanced clinical research management
Adverse Drug Experience
agent
Author_Deborah Rosenbaum
Author_Fred Smith
case
Category=PS
CFR
clinical
Clinical Investigations
clinical trial methodology
Compliance Program Guidance Manual
coordinator
CRC
CRFs
eq_bestseller
eq_isMigrated=1
eq_isMigrated=2
eq_nobargain
eq_non-fiction
eq_science
Expedited Review Procedure
FDA Information Sheet
FDA Regulation
form
Form FDA
IB
Informed Consent
Informed Consent Documents
Institutional Review Board
investigational
Investigational Agent
Investigational Drug
investigator's
IRB Approval
IRB Member
IRB Review
pharmacovigilance practices
Physician Investigator Handbook
protocol development strategies
regulatory compliance clinical studies
report
research
research ethics oversight
Safety Monitoring Board
Study Files
subject recruitment techniques
Test Article
Toxicity Grading Scales
trial

Product details

  • ISBN 9781574911244
  • Dimensions: 219 x 276mm
  • Publication Date: 01 Jan 2002
  • Publisher: Taylor & Francis Inc
  • Publication City/Country: US
  • Product Form: Hardback
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A comprehensive guide for physicians conducting clinical research, this second edition addresses a broader research perspective. It includes information on the implications of the ICH Guidelines, current FDA regulations, and an Internet address directory. Everything the clinical trial manager, planner, monitor, and investigator need to know about the design, establishment, monitoring, and close-out of a trial is in this book. The chapters address the elements of clinical research, professional interactions, FDA regulations and good clinical practices guidelines, investigational agent management, designing a study and protocol development, conducting the study, and more.
Rosenbaum, Deborah; Smith, Fred