Breaking down the Barriers – Electronic Data Capture

1. Breaking down the Barriers – Electronic Data Capture Jane Bentley and Vivienne Miller, i3 Research February 2006

2. Objectives of this session • To explore the definition of Electronic Data Capture • Identify the issues for the industry and the end user • Regulatory Environment (21 CFR Part 11) • Source Data – electronic vs. paper • Data archiving at site and within the industry • Identify key factors for success in a Clinical Trial using EDC

3. Definition of EDC

4. What is EDC? • Electronic Data Capture • What does this mean to you? • Our definition for EDC is any electronic data capture including electronic patient notes, IVR systems, eCRFs, patient diaries, Centralised lab reporting, etc, etc • Sometimes referred to as Remote Data Capture (RDC)

5. Project Manager Data Manager CRA Database Queries/ DCFs Data Entry Investigator CRFs Why Electronic Data Capture ?Paper-Based Trials

6. Time Data availability Patient recruitment trends Query resolution Database lock Quality Data validation Patient eligibility Handwriting & transcription Cost Data input Document printing & distribution CRA travel Paper Studies - Traditional Problems for the Industry

7. Time Time to Complete CRFs Query resolution Quantity of study related paper Review of data with CRA Over to you! What have we missed? Quality Delayed Data validation Clarity of Patient eligibility Inconsistencies of handwriting transcription Cost Photocopying Staff resources Archiving facilities Paper Studies - Traditional Problems for Sites

8. Database Data Manager Project Manager CRA Investigator Why Electronic Data Capture ?EDC Trials

9. Time Instant data availability Rapid trends reporting Quicker query resolution Faster database lock Quality On-line data & patient validation No handwriting or transcription problems Protocol updated on-line Cost No repeat data input No document printing or distribution Less CRA travel EDC Trials – Benefits for the Industry

10. Time Quicker query resolution Faster database lock Can you think of any other benefits? Quality On-line data & patient validation No handwriting or transcription problems Protocol updated on-line Cost Reduced Paperwork? Less Review time with CRA? EDC Trials – Benefits for Sites

11. Why Aren’t All Clinical Trials Using EDC ? The Industry Perspective The Need to Please • Unrealistic promises lead to unfulfilled expectations Resistance to Change • If it ain’t broke don’t fix it Avoidance • Not my responsibility Indecision • Let’s dip a toe in this, but not go all the way Fear • Will my provider be here next year ? • Reality: • not all trials are best suited to EDC (depending on phase, and size/ geographic region) • Lack of time for planning lead time for set up and training

12. Why Aren’t All Clinical Trials Using EDC ? • What’s your perspective?

13. NHS – Hospitals/ Primary Care IT Support/Logistics Needs up front planning Connectivity issues Firewall problems Other security issues Location of connectivity points Wireless technology security Investigator Sites: Requires training initially More timely queries Decreased queries Reduced archiving Principal Investigator role? Changed skill set for site staff Industry Project Managers Data visibility Clinical Monitoring Staff Decreased queries Changed workflow De facto first line of support of sites – (different skill set) Data Management No data entry Drug Safety / Pharmacovigilance Automatic SAE notification IT / Application Support Modified training needs for all staff Who Does EDC Affect ?

14. Regulatory Environment (21 CFR Part 11) • Governs Electronic Records and Signatures • Equivalent to hand written signatures • Linked to the relevant entered data • Linked to an identified individual Username and Password • Audit trail Who? What? When?

15. eSource What are the issues for the Industry? ICH GCP E6 Rules • 1.5.2 Source Documents - Original documents, data, and records (e.g. hospital records…, subjects’ diaries… • 4.9.2 Data reported on the CRF, which are derived from source documents, should be consistent with the source… • eSource data = source data captured initially into a permanent electronic record • Hospital Laboratory Data

16. eSource What are the issues at Site? • Multiple systems without electronic interface • Network access issues for CRAs and Site staff • Others? What is your perspective?

17. Data Archiving for EDC : points to consider What needs to be archived ? What format ? What medium ?

18. Making EDC Work

19. Key Success Factors Process Redesign • Data Management • Style of Interaction with site Site Assessment and Technical Setup • Timing • Done at site feasibility • Setup Method • Site Infrastructure • Provision the site Training • Timing • Investigator Meeting vs. Site Initiation • Method of Training Support • Method of access to support • Meeting the needs of the End User? • Adequate and appropriate Resourcing (out of hours/ local language support)

20. Site Assessment Success Site Questionnaire • Via CRAs or Technical Support • Information regarding • Site IT and Telecoms infrastructure • Staff IT capabilities Study Rollout • Non-EDC-suitable sites often merit further consideration for other options:- • Mixed paper-EDC study • Site provisioning

21. Site Setup : What does the Industry do to support you? Site Infrastructure • Key need to liaise with site system administrators where appropriate • Strong Support for the site through any software downloads / installations • Modify planning on-site monitoring Site Provisioning • Purchase and setup relevant laptops for sites • Setup and administer relevant telecoms for sites • Site close-out activities including retrieval of hardware and telecoms close-out • User Account Setup • The relevant accounts are created • activated ONLY once completed training documentation has been received • Qualified sites emailed individual usernames and passwords

22. Site Setup : What SHOULD the industry do to support you?

23. 6 1 5 2 3 4 Site Setup - The Challenge Source : Charles Jaffe, AstraZeneca

24. EDC Training Site Staff • EDC awareness presentation at Investigator Meeting • Present features and benefits • Site specific training via self directed computer based training (CBT) • Site specific materials - Training Manuals • Post-CBT Individual Face to Face training • Conducted by CRAs • Step-by-Step screen flow and study specific orientation

25. The Future

26. eClinical Trials Increased comfort Web based technology gives standardised access Fully integrated trial • Electronic Medical Records (would need significant harmonisation) • Interactive Voice Response Systems • Clinical Trial Management Systems • Electronic Data Capture system (patient and investigator) • External electronic data sources • SAE reporting/ pharmaco-vigilance systems • Electronic regulatory submission software