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

24

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: laura.cocking@plymouth.ac.uk