1. Laura Cocking Senior Data Manager Peninsula Clinical Trials Unit A Trial Manager’s Guide to Data Management 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 DesignSet-upConductAnalysis Report & publication 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 Exeter Clinical Trials Support Network Event 6 Staff time Equipment Outcome measures Postage Paper Randomisation

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 Monitoring – Verifying data – Raising data queries – Delegation logs – Ensuring GCP compliance Exeter Clinical Trials Support Network Event 6 Key DM Tasks

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 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 6 233, 120

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 DesignSet-upConductAnalysis Report & publication 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

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

19. 45 UKCRC registered CTUs Exeter Clinical Trials Support Network Event 6 Head of ICT Data Manager Database Manager Systems Specialist

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