A Trial Manager’s Guide to Data
Management
Laura Cocking
Senior Data Manager
Peninsula Clinical Trials Unit
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
• Hypothesis
• Study design
• Outcomes
• Sample size
• Feasibility
• PPI
• Costings
• Grant writing
Set-up
• Study sites
• CRN liaison
• Regulatory approvals
• Other permissions
• Registration
• Protocol
• Consent and PIS
• Case Report Forms
• Database design
• Logistics
• Training
• Contracts
Conduct
Analysis
• 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
Exeter Clinical Trials Support Network Event 6
Report &
publication
• Data
interpretation
• CONSORT
• Study reports
• Scientific writing
• Archiving
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 – Design
Key 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-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
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
Key DM Tasks
• Monitoring
– Verifying data
– Raising data
queries
– Delegation logs
– Ensuring GCP
compliance
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
233, 120
• 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
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
Lifecycle of a Study
Design
• Hypothesis
• Study design
• Outcomes
• Sample size
• Feasibility
• PPI
• Costings
• Grant writing
Set-up
• Study sites
• CRN liaison
• Regulatory approvals
• Other permissions
• Registration
• Protocol
• Consent and PIS
• Case Report Forms
• Database design
• Logistics
• Training
• Contracts
Conduct
Analysis
• 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
Exeter Clinical Trials Support Network Event 6
Report &
publication
• Data
interpretation
• CONSORT
• Study reports
• Scientific writing
• Archiving
45 UKCRC registered CTUs
Exeter Clinical Trials Support Network Event 6
45 UKCRC registered CTUs
Systems
Specialist
Data Manager
Database
Manager
Head of ICT
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 Cocking
Senior Data Manager
Tel: 01752 439828
Email: laura.cocking@plymouth.ac.uk
Exeter Clinical Trials Support Network Event 6