New Role Models for the EDC Study Team

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New Role Models for the EDC Study Team

• Training, workflow and service provision

DTI Conference Centre 1st November 2005
Emma Banks Datatrial Limited
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Aims

• To discuss the potential evolution of roles
• Examine workflow
• Discuss the need for front end standards

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So whats new?
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Conventional Roles

• Clinical Project Manager
• Clinical Trial Administration
• Clinical monitoring
• Clinical data management
• Statistics

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EDC Roles

• Clinical monitoring
• Clinical Monitoring / clinical data management
• Clinical Trial Administration / Clinical data
  management / Clinical Project Management
• Helpdesk
• Software and process trainers
• Statistics

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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?

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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?

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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

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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

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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

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Technical Data Manager

• Key skills
• eCRF design, database development, validation
  check programming, data import and export

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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

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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

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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?

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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?

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Role Overlap
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Workflow
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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!

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Common workflow elementsSet-Up
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Common workflow elementsProcessing
Database lock
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Training
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Training

• Which people require training?
• Delivery?
• Buy in?
• Who does it?
• When?
• Refresher training required?

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Support

• Helpdesk provision?
• Technical and operational support?
• Data
• Clinical
• Data managers / CTAs / CRAs?

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Service and Quality
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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

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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?

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EDC Standards

• Role evolution
• Standard workflow
• Standard terminology
• High quality training and support
• The reality

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