Abstract
When your clinical centre 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 subject 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. Because 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. During this process, the emphasis is on speed and accuracy. Always remember that there are many qualified sites able and willing to take on 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!
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
Grainge, M.J., Coupland, C.A., Cliffe, S.J. et al. (1998). Cigarette smoking, alcohol and caffeine consumption, and bone mineral density in postmenopausal women. The Nottingham EPIC Study Group. Osteoporos Int 8:355–63.
Expert Working Group (Efficacy) (1997). International Conference on Harmonization: Guidelines for Good Clinical Practice. Federal Register 62:25691–709. http://www.fda.gov/cder/guidance/959fnl.pdf accessed 13/11/06
Expert Working Group (Efficacy) (1995). International Conference on Harmonization: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting. Federal Register 60:11284–7. http://www.fda.gov/cder/guidance/iche2a.pdf accessed 20/11/06
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2007 Springer-Verlag London Limited
About this chapter
Cite this chapter
Adams, D., Miller, C.G. (2007). Local Site Organization. In: Pearson, D., Miller, C.G. (eds) Clinical Trials in Osteoporosis. Clinical Trials. Springer, London. https://doi.org/10.1007/978-1-84628-587-5_6
Download citation
DOI: https://doi.org/10.1007/978-1-84628-587-5_6
Publisher Name: Springer, London
Print ISBN: 978-1-84628-389-5
Online ISBN: 978-1-84628-587-5
eBook Packages: MedicineMedicine (R0)