1. New Role Models for the EDC Study Team Training, workflow and service provision DTI Conference Centre 1 st November 2005 Emma Banks Datatrial Limited

2. Aims  To discuss the potential evolution of roles  Examine workflow  Discuss the need for front end standards

3. So what’s new? EDC system PeopleProcessQualityServiceRoles

4. Conventional Roles  Clinical Project Manager  Clinical Trial Administration  Clinical monitoring  Clinical data management  Statistics

5. EDC Roles  Clinical monitoring  Clinical Monitoring / clinical data management  Clinical Trial Administration / Clinical data management / Clinical Project Management  Helpdesk  Software and process trainers  Statistics

6. Do roles need to change?  Clinical monitoring  Clinical monitoring / Clinical data management  Clinical Trial Administration / Study operations manager / Clinical data management  Will a merging of these roles help?  Helpdesk – who does this?  Software and process trainers – how and when, by who?  Statistics – has it changed?

7. New EDC Roles  Clinical trial administration and clinical data management and / or Clinical monitoring and clinical data management:  Is this viable as a standard?  How are companies structured?  What are the training needs?  What happens to the technical skills that reside within CDM?

8. Clinical Research Associate  Key skills  Specific clinical knowledge, assisting sites in applying for ethical approval, negotiating, liaison with the investigator and site staff, ensuring adherence to the protocol, source data verification, query management, some data management, planning and time management

9. Clinical Research Associate and Clinical Data Manager  Key skills  Specific clinical knowledge, assisting sites in applying for ethical approval, negotiating, liaison with the investigator and site staff, ensuring adherence to the protocol, source data verification, query management, significant data management, planning and time management

10. Clinical Trial Administrator and Clinical Data Manager  Key skills  Understanding and training in the clinical trial process, protocol development, recruitment and reporting, drug supplies and logistics, data capture process, data reporting requirements, project management  Management of the study requirements rather than ‘doing’ the job

11. Technical Data Manager  Key skills  eCRF design, database development, validation check programming, data import and export

12. Helpdesk  Key skills  Technical software knowledge, study understanding and ability to assist with software and clinical issues  Assume helpdesk is more than one tier and comes through Technical and goes onto Operations eg CDM, CRA, CTA

13. Training  Key skills  Technical and end user understanding of software, good delivery methods, cost effective refresher training, real hands on experience of the system in use and the issues a site may have

14. Statistics  Key skills  Trial and protocol understanding, control over data access and data mining during the course of the study, protocol deviation review, improved data quality, fraud detection, reduced patient numbers?

15. Do we need standard roles for EDC?  Are the conventional skill divisions enough?  Or are they too much?  Redundancy  Re-aligning  Are we being objective when ‘re-structuring’ for EDC?  What about training needs?

16. Role Overlap Clinical Data Management Training Helpdesk Clinical monitor Clinical Trial management

17. Workflow EDC system PeopleProcessQualityServiceRoles

18. Workflow and Process  System independent?  Simple?  Complex?  Standards across systems?  Standard functionality?  Standard terminology?  We expect sites to be experts on many systems however, we would rarely expect this of a data manager!

19. Common workflow elements Set-Up 2 UAT (end user) 3 Feedback 1 eCRF design Validation check specification and programming

20. Common workflow elements Processing 1 Data capture and preliminary cleaning 2 Source Data Verification CRA queries 3 Investigator sign off 4 CDM step Queries Coding SAE handling 6 No further changes required 5 Data amendment/update Addition of new data Database lock

21. Training EDC system PeopleProcessQualityServiceRoles

22. Training  Which people require training?  Delivery?  Buy in?  Who does it?  When?  Refresher training required?

23. Support  Helpdesk provision?  Technical and operational support?  Data  Clinical  Data managers / CTAs / CRAs?

24. Service and Quality EDC system PeopleProcessQualityServiceRoles

25. Service and Quality  Who are your customers?  Can standards affect service provision?  Efficiency  Cost  Quality improved?  Data reporting efficiency?  Clinical team e.g. metrics, recruitment  Statistics e.g. protocol deviations, safety summaries

26. What is the ideal?  Increased efficiency across all functions  High standard of service and quality  Clear objectives for training and support  Expedited reporting and efficient use of trial numbers  Are these all equal?  Which is most important?  How do we achieve this?

27. EDC Standards  Role evolution  Standard workflow  Standard terminology  High quality training and support  The reality………………

28. emma.banks@datatrial.com