Monitoring Staff Participation in EDC Design and Testing
Ockham’s experience indicates that monitoring staff must be involved with the set-up, development, and testing of the EDC system. Ockham believes that as a monitor would be involved in CRF design and review (in a paper-based study), so too should the monitor be involved in EDC through:
- Review of initial eCRF design and navigation
- Participation in development of EDC training for sites
- Participation in User Acceptance Testing (UAT) for 21CFR Part 11 compliance testing.

Monitoring Staff Use of the EDC System During Monitoring
Ockham’s experience further suggests that a major advantage (for monitoring) of EDC is its use for pre-, intermediate, and post-visit data review by the monitor:
Prior to a Monitoring Visit – Monitor reviews all eCRFs entered at the site; notes areas of concern and uses material to develop visit plan for site:
- During a Monitoring Visit – Monitor reviews data with site personnel and uses review to facilitate early detection of data issues; monitor also works with site personnel on eCRF training and compliance issues
- After a Monitoring Visit – Monitor reviews eCRF for timely eCRF entry (by site) and query responses.

Monitor Management and Interaction with Site Personnel
Ockham believes that the monitor must link management to eCRF completion. This link ranges from ensuring that site compensation is associated with eCRF completion to day-to-day management of query resolution.

Each of these EDC-specific procedures is embedded in all Ockham Monitoring Plans.
Approximately 40% of Ockham’s clinical monitoring is executed using an EDC system. Although Ockham generally does not recommend specific brands of software, it has had the best experience with etrials® and Nextrials PrismTM.