Table 3.

The grouping of features into a six-level cumulative scale of EDC sophistication as determined through a Guttman scalogram analysis: higher levels signify more sophistication

Sophistication Level	Features
1	f1.	There is a unique account and password for each user to access the online system.
2	f2.	Subject visit data are entered by sites through a Web interface into electronic case report forms (eCRFs).
	f3.	The completion status of each eCRF for each subject can be tracked automatically online; for example, you can see which visits have complete data and which still have incomplete eCRFs for each subject.
	f4.	The system provides an audit trail for all data entry and data modification.
3	f5.	Data validation happens automatically when data are entered into the eCRF (either right away or when the user presses the SUBMIT button), for example, to check for out-of-range values.
	f6.	The system will automatically log the user off after a period of inactivity.
4	f7.	Subjects are randomized automatically, either through an automated telephone response system or through a Web interface.
5	f8.	Subject recruitment can be tracked online for each site; for example, the user can see a graph of recruited and not withdrawn subjects over time.
6	f9.	The system allows tracking of medication inventory at the sites.