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Setting Up and Carrying Out a Clinical Trial

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This chapter describes the main steps involved in carrying out a clinical trial using Siebel eClinical. Following the procedures given in this chapter you will be able to:

Create a clinical program and clinical protocols
Set up document tracking at the protocol, region, and site levels, and for accounts and contacts
Set up and revise subject visit templates for a protocol
Enter data on accounts, sites, and contacts
Screen and enroll subjects
View charts showing subject status and enrollment rates
Review payments made to the protocol

Figure 9 illustrates the important hierarchical relationship of programs, protocols, regions, and sites. In this example, the Bristol General Hospital in the USA region is participating in the AMXN 98447 protocol, which is being carried out as part of the Anemia program.

Figure 9.  Siebel eClinical Hierarchical Relationships

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