Lessons from a horse named Jim : a clinical trials manual from the Duke Clinical Research Institute /

Bibliographic Details
Main Author:	Liu, Margaret B.
Corporate Author:	Duke Clinical Research Institute
Other Authors:	Davis, Kate
Format:	Book
Language:	English
Subjects:	Drug Evaluation. Clinical Trials as Topic.

Table of Contents:

Lessons from a horse named Jim: a history of regulations affecting clinical research
The process: developing new drugs and devices
Good clinical practice and the regulations
Informed consent and the regulations
Adverse events
Monitoring
Deciding to be a Principal Investigator
The protocol
Study activities
Study documents
Study drug management
Patient data forms