Exeter Clinical Trials Support Network Event 6
Laura CockingSenior Data Manager
Peninsula Clinical Trials Unit
A Trial Manager’s Guide to Data Management
Exeter Clinical Trials Support Network Event 6
What is Data Management?
Exeter Clinical Trials Support Network Event 6
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
Lifecycle of a Study
Design Set-up Conduct AnalysisReport & publicatio
n
•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
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
Lifecycle of a Study – DesignKey DM Tasks
• Calculate Data Management costs
• Staff time• Equipment• Outcome measures
• Postage• Paper• Randomisation
Exeter Clinical Trials Support Network Event 6
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
Lifecycle of a Study – Set-upKey DM Tasks
• Design and create Case Report Forms (CRF), questionnaire booklets and any other data collection forms
Exeter Clinical Trials Support Network Event 6
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
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
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
Lifecycle of a Study – Conduct
• Monitoring– Verifying data– Raising data
queries– Delegation logs– Ensuring GCP
compliance
Key DM Tasks
Exeter Clinical Trials Support Network Event 6
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
Lifecycle of a Study – Conduct
Exeter Clinical Trials Support Network Event 6
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
233, 120
Exeter Clinical Trials Support Network Event 6
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
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Lifecycle of a Study
Design Set-up Conduct AnalysisReport & publicatio
n
•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
45 UKCRC registered CTUs
Exeter Clinical Trials Support Network Event 6
45 UKCRC registered CTUs
Computer Manager
Programming
Team Leader
Head of ICT
Clinical Trials
IT Officer
Data Manager
Information Management
Database Manager
Systems Specialist
System
Developer
IT Co-ordinator
Data Programmer
IT Manager
Exeter Clinical Trials Support Network Event 6
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
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 CockingSenior Data Manager
Tel: 01752 439828Email: [email protected]