Deborah Rosenbaum,
Fred Smith
Physician Investigator Handbook
GCP Tools and Techniques, Second Edition
Gebonden Engels 2002 1e druk 9781574911244Levertijd ± 11 werkdagen
Gratis verzonden
Samenvatting
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.
Specificaties
Lezersrecensies
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Inhoudsopgave
Overview and Elements of Clinical Research. The Physician as Investigator. Professional Interactions. FDA Regulations and Good Clinical Practices Guidelines. Investigational Agent Management. Designing a Study and Protocol Development. The Informed Consent Process. Conducting the Study. Monitoring of Clinical Trials. Interactions with the Study Subjects. Adverse Events and Drug Safety. Data Management. The Study Results. Audits of Clinical Research Sites.
Rubrieken
- advisering
- algemeen management
- coaching en trainen
- communicatie en media
- economie
- financieel management
- inkoop en logistiek
- internet en social media
- it-management / ict
- juridisch
- leiderschap
- marketing
- mens en maatschappij
- non-profit
- ondernemen
- organisatiekunde
- personal finance
- personeelsmanagement
- persoonlijke effectiviteit
- projectmanagement
- psychologie
- reclame en verkoop
- strategisch management
- verandermanagement
- werk en loopbaan