Fundamentals of GCP and Clinical Research
- Indbinding:
- Paperback
- Sideantal:
- 86
- Udgivet:
- 15. august 2013
- Størrelse:
- 140x216x5 mm.
- Vægt:
- 109 g.
- 2-3 uger.
- 9. december 2024
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Abonnementspris
- Rabat på køb af fysiske bøger
- 1 valgfrit digitalt ugeblad
- 20 timers lytning og læsning
- Adgang til 70.000+ titler
- Ingen binding
Abonnementet koster 75 kr./md.
Ingen binding og kan opsiges når som helst.
- 1 valgfrit digitalt ugeblad
- 20 timers lytning og læsning
- Adgang til 70.000+ titler
- Ingen binding
Abonnementet koster 75 kr./md.
Ingen binding og kan opsiges når som helst.
Beskrivelse af Fundamentals of GCP and Clinical Research
This book is intended to provide a fundamental knowledge on Clinical Research and Good Clinical Practice (GCP) Guidelines with a crisp description on important topics such as Introduction to Clinical Research; Evolution of Ethical Research Principles, Regulations and Guidelines; Essential Clinical Trial Documents; Clinical Study Process; Ethics Review Board (ERB); Roles and Responsibilities of Investigator; Roles and Responsibilities of Sponsor; Informed Consent Process; Serious Adverse Event (SAE), Maintenance of Source Document, IND/NDA/ANDA/AADA and List/Location of Essential Trial Documents Before, During and After Completion/Termination of the Trial.
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