Transcript Main Title Here - Clinical & Contract Research Association

New Role Models for the EDC
Study Team
Training, workflow and service
provision
DTI Conference Centre
1st November 2005
Emma Banks
Datatrial Limited
Aims
 To discuss the potential evolution of roles
 Examine workflow
 Discuss the need for front end standards
So what’s new?
People
Roles
Process
EDC system
Service
Quality
Conventional Roles
 Clinical Project Manager
 Clinical Trial Administration
 Clinical monitoring
 Clinical data management
 Statistics
EDC Roles
 Clinical monitoring
 Clinical Monitoring / clinical data management
 Clinical Trial Administration / Clinical data management /
Clinical Project Management
 Helpdesk
 Software and process trainers
 Statistics
Do roles need to change?
 Clinical monitoring
 Clinical monitoring / Clinical data management
 Clinical Trial Administration / Study operations manager /
Clinical data management
 Will a merging of these roles help?
 Helpdesk – who does this?
 Software and process trainers – how and when, by who?
 Statistics – has it changed?
New EDC Roles

Clinical trial administration and clinical data management and / or
Clinical monitoring and clinical data management:
 Is this viable as a standard?
 How are companies structured?
 What are the training needs?
 What happens to the technical skills that reside within CDM?
Clinical Research Associate

Key skills
 Specific clinical knowledge, assisting sites in applying for ethical
approval, negotiating, liaison with the investigator and site staff,
ensuring adherence to the protocol, source data verification, query
management, some data management, planning and time management
Clinical Research Associate and
Clinical Data Manager

Key skills
 Specific clinical knowledge, assisting sites in applying for ethical
approval, negotiating, liaison with the investigator and site staff,
ensuring adherence to the protocol, source data verification, query
management, significant data management, planning and time
management
Clinical Trial Administrator and Clinical
Data Manager

Key skills
 Understanding and training in the clinical trial process, protocol
development, recruitment and reporting, drug supplies and logistics,
data capture process, data reporting requirements, project
management
 Management of the study requirements rather than ‘doing’ the job
Technical Data Manager
 Key skills
 eCRF design, database development, validation check
programming, data import and export
Helpdesk
 Key skills
 Technical software knowledge, study understanding and ability
to assist with software and clinical issues
 Assume helpdesk is more than one tier and comes through
Technical and goes onto Operations eg CDM, CRA, CTA
Training
 Key skills
 Technical and end user understanding of software, good delivery
methods, cost effective refresher training, real hands on
experience of the system in use and the issues a site may have
Statistics
 Key skills
 Trial and protocol understanding, control over data access and
data mining during the course of the study, protocol deviation
review, improved data quality, fraud detection, reduced patient
numbers?
Do we need standard roles for EDC?

Are the conventional skill divisions enough?

Or are they too much?
 Redundancy
 Re-aligning

Are we being objective when ‘re-structuring’ for EDC?

What about training needs?
Role Overlap
Clinical Data Management
Clinical Trial management
Clinical monitor
Training
Helpdesk
Workflow
People
Process
Roles
EDC system
Service
Quality
Workflow and Process

System independent?

Simple?

Complex?

Standards across systems?

Standard functionality?

Standard terminology?

We expect sites to be experts on many systems however, we would
rarely expect this of a data manager!
Common workflow elements
Set-Up
1
eCRF design
Validation
check
specification
and
programming
2
UAT
(end user)
3
Feedback
Common workflow elements
Processing
5
Data
amendment
/update
Addition of
new data
Database lock
6
No further changes required
1
Data
capture and
preliminary
cleaning
2
Source Data Verification
CRA queries
4
CDM step
Queries
Coding
SAE
handling
3
Investigator sign
off
Training
People
Roles
Process
EDC system
Service
Quality
Training
 Which people require training?
 Delivery?
 Buy in?
 Who does it?
 When?
 Refresher training required?
Support
 Helpdesk provision?
 Technical and operational support?
 Data
 Clinical
 Data managers / CTAs / CRAs?
Service and Quality
People
Roles
Process
EDC system
Service
Quality
Service and Quality
 Who are your customers?
 Can standards affect service provision?
 Efficiency
 Cost
 Quality improved?
 Data reporting efficiency?
 Clinical team e.g. metrics, recruitment
 Statistics e.g. protocol deviations, safety summaries
What is the ideal?
 Increased efficiency across all functions
 High standard of service and quality
 Clear objectives for training and support
 Expedited reporting and efficient use of trial numbers
 Are these all equal?
 Which is most important?
 How do we achieve this?
EDC Standards
 Role evolution
 Standard workflow
 Standard terminology
 High quality training and support
 The reality………………
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