Laura Cocking Senior Data Manager Peninsula Clinical Trials Unit

1. A Trial Manager’s Guide to Data Management Laura Cocking Senior Data Manager Peninsula Clinical Trials Unit Exeter Clinical Trials Support Network Event 6

2. What is Data Management? Exeter Clinical Trials Support Network Event 6

3. What is Data Management? “Data management comprises all the disciplines related to managing data as a valuable resource” http://en.wikipedia.org/wiki/Data_management “Data management is the process of controlling the information generated during a research project.” www.google.co.uk “Administrative process by which the required data is acquired, validated, stored, protected, and processed, and by which its accessibility, reliability, and timeliness is ensured to satisfy the needs of the data users.” http://www.businessdictionary.com/definition/data-management.html Exeter Clinical Trials Support Network Event 6

4. Lifecycle of a Study • Hypothesis • Study design • Outcomes • Sample size • Feasibility • PPI • Costings • Grant writing • Study sites • CRN liaison • Regulatory approvals • Other permissions • Registration • Protocol • Consent and PIS • Case Report Forms • Database design • Logistics • Training • Contracts • Trial & data management • Randomisation • Risk assessment • Monitoring • AE reporting • Governance • Trial meetings • TSC and DMC • Reports • Finance • Stats analysis plan • Data validation • Interim analysis • Programming and analysis • Economic evaluation • Qualitative element • Data interpretation • CONSORT • Study reports • Scientific writing • Archiving Exeter Clinical Trials Support Network Event 6

5. Lifecycle of a Study – Design Key DM Tasks • Advise on data collection methods • How • When • Who • Suggest outcome measures • Assist with writing grant proposal Exeter Clinical Trials Support Network Event 6

6. Lifecycle of a Study – Design Key DM Tasks • Calculate Data Management costs • Staff time • Equipment • Outcome measures • Postage • Paper • Randomisation Exeter Clinical Trials Support Network Event 6

7. Lifecycle of a Study – Set-up Key DM Tasks • Finalise data collection methods and data flow • Finalise outcome measures • Write any relevant sections of protocol • Ensure PIS and consent form meet the standards of the Data Protection Act Exeter Clinical Trials Support Network Event 6

8. Lifecycle of a Study – Set-up Key DM Tasks • Design and create Case Report Forms (CRF), questionnaire booklets and any other data collection forms Exeter Clinical Trials Support Network Event 6

9. Designing CRFs • Simple layout • Sensible order • Tick boxes • Minimal free text • Place holders • Need to know vs. Nice to know Exeter Clinical Trials Support Network Event 6

10. Lifecycle of a Study – Set-up Key DM Tasks • Database design and development • Requirements specification • Protocol • CRFs, data collection forms, questionnaires • Data flow diagram • Randomisation method and/or lists • Training Exeter Clinical Trials Support Network Event 6

11. Lifecycle of a Study – Conduct Key DM Tasks • Printing documents • Posting documents and equipment e.g. questionnaires, CRFs, accelerometers • Reminding site staff about visits • Receiving data • Chasing outstanding data • Entering data (double entry for most studies) • Managing AEs and SAEs Exeter Clinical Trials Support Network Event 6

12. Lifecycle of a Study – Conduct Key DM Tasks • Monitoring • Verifying data • Raising data queries • Delegation logs • Ensuring GCP compliance Exeter Clinical Trials Support Network Event 6

13. Lifecycle of a Study – Conduct Key DM Tasks • Reporting • Attendance at TMG meetings • Reporting recruitment • Problem data • Problem sites • AEs and SAEs • Providing data for DMC or TSC reports • Providing data for newsletter Exeter Clinical Trials Support Network Event 6

14. Lifecycle of a Study – Conduct Exeter Clinical Trials Support Network Event 6

15. Lifecycle of a Study – Analysis 233, 120 Key DM Tasks • Data validation • Cleaning • Logic checks • Outliers • Missing data • Verifying with source • Querying with site staff • Amending data (All amendments logged as part of database audit trail) • Export clean data • Apply scoring algorithms Exeter Clinical Trials Support Network Event 6

16. Lifecycle of a Study – Report and Publication Key DM Tasks • Assist with data interpretation • Export numbers to populate CONSORT • Review any papers written about the study • Archiving • Electronic • Paper Exeter Clinical Trials Support Network Event 6

17. Lifecycle of a Study • Hypothesis • Study design • Outcomes • Sample size • Feasibility • PPI • Costings • Grant writing • Study sites • CRN liaison • Regulatory approvals • Other permissions • Registration • Protocol • Consent and PIS • Case Report Forms • Database design • Logistics • Training • Contracts • Trial & data management • Randomisation • Risk assessment • Monitoring • AE reporting • Governance • Trial meetings • TSC and DMC • Reports • Finance • Stats analysis plan • Data validation • Interim analysis • Programming and analysis • Economic evaluation • Qualitative element • Data interpretation • CONSORT • Study reports • Scientific writing • Archiving 24 Exeter Clinical Trials Support Network Event 6

18. 45 UKCRC registered CTUs Exeter Clinical Trials Support Network Event 6

19. 45 UKCRC registered CTUs Systems Specialist IT Manager Information Management IT Co-ordinator Computer Manager Data Manager Clinical Trials IT Officer Data Programmer Programming Team Leader System Developer Head of ICT Database Manager Exeter Clinical Trials Support Network Event 6

20. Summary • Data Management is a broad topic and is hard to define • Data Management is covered by several job roles • Data Management can be different from project to project, and between CTUs or CROs Exeter Clinical Trials Support Network Event 6

21. A Trial Manager’s Guide to Data Management – Key Messages • Your study as only as good as the data collected • Hire a Data Manager!! Laura Cocking Senior Data Manager Tel: 01752 439828 Email: laura.cocking@plymouth.ac.uk Exeter Clinical Trials Support Network Event 6