Breaking down the Barriers Electronic Data Capture

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Breaking down the Barriers Electronic Data
Capture
Jane Bentley and Vivienne Miller, i3
Research February 2006
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Objectives of this session

• To explore the definition of Electronic Data
  Capture
• Identify the issues for the industry and the end
  user
• Regulatory Environment (21 CFR Part 11)
• Source Data electronic vs. paper
• Data archiving at site and within the industry
• Identify key factors for success in a Clinical
  Trial using EDC

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Definition of EDC
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What is EDC?

• Electronic Data Capture
• What does this mean to you?
• Our definition for EDC is any electronic data
  capture including electronic patient notes, IVR
  systems, eCRFs, patient diaries, Centralised lab
  reporting, etc, etc
• Sometimes referred to as Remote Data Capture
  (RDC)

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Why Electronic Data Capture ?Paper-Based Trials
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Paper Studies - Traditional Problems for the
Industry
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Paper Studies - Traditional Problems for Sites
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Why Electronic Data Capture ?EDC Trials
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EDC Trials Benefits for the Industry
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EDC Trials Benefits for Sites
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Why Arent All Clinical Trials Using EDC ?

• The Industry Perspective
• The Need to Please
• Unrealistic promises lead to unfulfilled
  expectations
• Resistance to Change
• If it aint broke dont fix it
• Avoidance
• Not my responsibility
• Indecision
• Lets dip a toe in this, but not go all the way
• Fear
• Will my provider be here next year ?
• Reality
• not all trials are best suited to EDC (depending
  on phase, and size/ geographic region)
• Lack of time for planning lead time for set up
  and training

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Why Arent All Clinical Trials Using EDC ?

• Whats your perspective?

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Who Does EDC Affect ?

• NHS Hospitals/ Primary Care
• IT Support/Logistics
• Needs up front planning
• Connectivity issues
• Firewall problems
• Other security issues
• Location of connectivity points
• Wireless technology security
• Investigator Sites
• Requires training initially
• More timely queries
• Decreased queries
• Reduced archiving
• Principal Investigator role?
• Changed skill set for site staff

• Industry
• Project Managers
• Data visibility
• Clinical Monitoring Staff
• Decreased queries
• Changed workflow
• De facto first line of support of sites
  (different skill set)
• Data Management
• No data entry
• Drug Safety / Pharmacovigilance
• Automatic SAE notification
• IT / Application Support
• Modified training needs for all staff

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Regulatory Environment (21 CFR Part 11)

• Governs Electronic Records and Signatures
• Equivalent to hand written signatures
• Linked to the relevant entered data
• Linked to an identified individual
• Username and Password
• Audit trail
• Who?
• What?
• When?

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eSource

• What are the issues for the Industry?
• ICH GCP E6 Rules
• 1.5.2 Source Documents - Original documents,
  data, and records (e.g. hospital records,
  subjects diaries
• 4.9.2 Data reported on the CRF, which are derived
  from source documents, should be consistent with
  the source
• eSource data source data captured initially
  into a permanent electronic record
• Hospital Laboratory Data

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eSource

• What are the issues at Site?
• Multiple systems without electronic interface
• Network access issues for CRAs and Site staff
• Others?
• What is your perspective?

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Data Archiving for EDC points to consider

• What needs to be archived ?
• What format ?
• What medium ?

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Making EDC Work
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Key Success Factors

• Process Redesign
• Data Management
• Style of Interaction with site
• Site Assessment and Technical Setup
• Timing
• Done at site feasibility
• Setup Method
• Site Infrastructure
• Provision the site
• Training
• Timing
• Investigator Meeting vs. Site Initiation
• Method of Training
• Support
• Method of access to support
• Meeting the needs of the End User?
• Adequate and appropriate Resourcing (out of
  hours/ local language support)

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Site Assessment Success

• Site Questionnaire
• Via CRAs or Technical Support
• Information regarding
• Site IT and Telecoms infrastructure
• Staff IT capabilities
• Study Rollout
• Non-EDC-suitable sites often merit further
  consideration for other options-
• Mixed paper-EDC study
• Site provisioning

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Site Setup What does the Industry do to
support you?

• Site Infrastructure
• Key need to liaise with site system
  administrators where appropriate
• Strong Support for the site through any software
  downloads / installations
• Modify planning on-site monitoring
• Site Provisioning
• Purchase and setup relevant laptops for sites
• Setup and administer relevant telecoms for sites
• Site close-out activities including retrieval of
  hardware and telecoms close-out
• User Account Setup
• The relevant accounts are created
• activated ONLY once completed training
  documentation has been received
• Qualified sites emailed individual usernames and
  passwords

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Site Setup

• What SHOULD the industry do to support you?

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Site Setup - The Challenge
Source Charles Jaffe, AstraZeneca
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EDC Training

• Site Staff
• EDC awareness presentation at Investigator
  Meeting
• Present features and benefits
• Site specific training via self directed computer
  based training (CBT)
• Site specific materials - Training Manuals
• Post-CBT Individual Face to Face training
• Conducted by CRAs
• Step-by-Step screen flow and study specific
  orientation

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The Future
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eClinical Trials

• Increased comfort
• Web based technology gives standardised access
• Fully integrated trial
• Electronic Medical Records (would need
  significant harmonisation)
• Interactive Voice Response Systems
• Clinical Trial Management Systems
• Electronic Data Capture system (patient and
  investigator)
• External electronic data sources
• SAE reporting/ pharmaco-vigilance systems
• Electronic regulatory submission software