1. Worldwide Development Quality Assurance
DIA GCP/QA SIAC Auditing Electronic Data Capture Studies- Tips and Lessons Learned
Nancy Bitters
Manager
Worldwide Development Quality Assurance
Pfizer, Inc.
24 October 2006

2. Agenda Setting expectations Account Management
PI Review of Electronic Data
Equipment
Training
Communications
eCRFs at the end of the study
Regulatory Environment

3. Objectives
Discuss some common themes, tips, lessons learned and issues surrounding auditing EDC studies

4. Setting expectations
How soon after patient visits does sponsor expect data to be entered into EDC system
Direct data entry (no source) – is this acceptable?
Use of printed version of eCRF as source – is this acceptable?
Expectations of monitors- can they do remote monitoring of data (for completeness/edit checks)- if so, what is timeframe expectation?

5. Account Management Ensure that active users only have accounts
Ensure that access level is consistent/adequate for study duties (PI vs. CRC)
Default passwords should be changed
Passwords, usernames should not be displayed (i.e. yellow sticky on computer, memo in reg binder)

6. PI Review of Electronic Data
Level of review that sponsor expects
Communication of necessary review to PI’s
Delegation of CRF review to sub investigator
Documentation of review (audit trail/memo/SOP)

7. Equipment Ensure secured location
Access- does software need internet connection? (may not be possible at all sites- i.e. hospitals)
Use of wireless cards for connectivity
Upload schedule
Printer provided?
Source to be provided? (use of screen prints of eCRF)
Will access to worldwide web be permitted/necessary? (Risks associated)

8. Training Do all users have documented training?
(on the version(s) of software in use…)
Are all versions of user manuals available at the site for software used?
Training documentation available in both the Trial Master File and the Site Master File?

9. Communications
Are all significant communications relating to EDC (hardware and software) in the Trial Master File and the Site Master File?
How are sites and monitors notified of releases/outages?

10. End of the study- Next Steps
Training of monitors/Study teams in end of study processes
Communication to sites on end of study processes
What media will be used for site copy of eCRF data?
Audit trail for data included?
Verification/tracking of copy of eCRF to sites
Will equipment (laptop, printer, etc) be needed?
Will equipment be left at sites?
Donation of equipment/warranty transfer/useable?
Adequate storage?

11. Regulatory Environment
How experienced/comfortable are regulators in reviewing eCRFs?
Will regulators require/ask that eCRFs be printed for them during inspections?