Skip to main content Accessibility help
×
Hostname: page-component-848d4c4894-wg55d Total loading time: 0 Render date: 2024-04-30T16:01:18.279Z Has data issue: false hasContentIssue false

Chapter 9 - Clinical trials management at the site level

Published online by Cambridge University Press:  05 July 2012

Amir Kalali
Affiliation:
University of California, San Diego
Sheldon Preskorn
Affiliation:
University of Kansas School of Medicine
Joseph Kwentus
Affiliation:
University of Mississippi
Stephen M. Stahl
Affiliation:
University of California, San Diego
Get access

Summary

This chapter explains common practices and customs at the CNS drug trial site, a complex ingredient in the recipe for new medicines. The organization diagram of most trial sites is simple. The critical ingredients are the principal investigator and the clinical coordinators. Investigators conduct CNS clinical trials in diverse local settings, various size businesses, and different national cultures. Success depends on the talents of people with various backgrounds, training, and experience. Doctors prescribe for patients who live in many different environments; therefore, research settings parallel the clinic setting where patients are likely to take the medicines. FDA demands the investigator assign trial roles and train the staff. Repeat business from satisfied sponsors is not only the benchmark of success, but research sites perform best when they pick up a drug early and stay with it throughout the product life cycle.
Type
Chapter
Information
Publisher: Cambridge University Press
Print publication year: 2012

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

Save book to Kindle

To save this book to your Kindle, first ensure coreplatform@cambridge.org is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about saving to your Kindle.

Note you can select to save to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be saved to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

Find out more about the Kindle Personal Document Service.

Available formats
×

Save book to Dropbox

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Dropbox.

Available formats
×

Save book to Google Drive

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Google Drive.

Available formats
×