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About Setting Up and Carrying Out a Clinical Trial

This chapter describes the main steps involved in carrying out a clinical trial using Siebel Clinical. 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 10 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 10. Siebel Clinical Hierarchical Relationships