Clinical research : from proposal to implementation

Bibliographic Details
Main Authors: McPhaul, Michael J. (Author), Toto, Robert D. (Author)
Format: Book
Language:English
Published: Philadelphia : Lippincott Williams & Wilkins Health , 2011
Subjects:
Table of Contents:
  • 1. How to launch a succesful career in clinical research: tips onmaking the most of avalaible resources
  • 2. Institutional review board approval
  • 3. Writing informed consent documents and obtaining informed consent
  • 4. Ethics of data sharing and gandling of genetic information
  • 5. Writing a statistical analysis plan
  • 6. Protocol implementation procedures
  • 7. Screening and evaluation
  • 8. Recruitment and retention
  • 9. How to set up your database
  • 10. Budgeting process and management
  • 11. Understanding food and drug administration regulatory requirements for investigational new drug applications for sponsor-investigations
  • 12. Collecting data
  • 13. Data and safety monitoring
  • 14.Presenting, writing and publishing challenges