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Local Site Organization

  • Dorothy Adams
  • Colin G. Miller

Abstract

When your clinical center has been notified that you have been selected as a site for a new clinical trial in osteoporosis, you can be assured that the sponsor has made an assessment of the patient population and facilities available. It is now up to the investigator, site administrator and staff to prove the sponsor made the right decision in placing the study at their site. Since delays in study start-up can cause a sponsor to lose millions of dollars, it is imperative to get the study up and running as soon as possible. In this process the emphasis is on speed and accuracy. Always remember that there are many qualified sites able and willing to do this project should your commitment falter. You can congratulate yourself that you have been chosen to participate, but the site must be organized to get to work on the project quickly!

Keywords

Study Drug Study Staff Adverse Event Report Bone Density Test Curriculum Vita 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

  1. 1.
    Grainge MJ, Coupland CA, Cliffe SJ, Chilvers CE, Hosking DJ. Cigarette smoking, alcohol and caffeine consumption, and bone mineral density in postmenopausal women. The Nottingham EPIC Study Group. Osteoporos Int 1998; 8: 355–63.PubMedCrossRefGoogle Scholar
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    International Conference on Harmonisation: Guidelines for Good Clinical Practice. Federal Register 1997;62:25691–709. (Available at http://www.fda.gov/cder/guidance/959fnl.pdf)
  3. 3.
    International Conference on Harmonisation: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting. Federal Register 1995;60:11284–7. (Available at http://www.fda.gov/cder/guidance/iche2a.pdf)

Copyright information

© Springer-Verlag London 2002

Authors and Affiliations

  • Dorothy Adams
  • Colin G. Miller

There are no affiliations available

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