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Breaking down the Barriers –

Electronic Data Capture

Jane Bentley and Vivienne Miller, i3 Research
February 2006
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
Definition of EDC
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)

Why Electronic Data Capture ?
Paper-Based Trials

Data Project
Manager Manager


Queries/ Database

Paper Studies - Traditional Problems for the Industry

Time Cost
Data availability Data input
Patient recruitment trends Document printing &
Query resolution distribution
Database lock CRA travel

Data validation
Patient eligibility
Handwriting & transcription
Paper Studies - Traditional Problems for Sites

Time Cost
Time to Complete CRFs Photocopying
Query resolution
Staff resources
Quantity of study related paper
Archiving facilities
Review of data with CRA

Delayed Data validation
Clarity of Patient eligibility
Inconsistencies of handwriting

Over to you! What have we missed?

Why Electronic Data Capture ?
EDC Trials

Manager Project


Investigator Database
EDC Trials – Benefits for the Industry

Time Cost
Instant data availability No repeat data input
Rapid trends reporting No document printing or
Quicker query resolution distribution
Faster database lock Less CRA travel

On-line data & patient validation
No handwriting or transcription
Protocol updated on-line
EDC Trials – Benefits for Sites

Time Cost
Quicker query resolution Reduced Paperwork?
Faster database lock Less Review time with

On-line data & patient validation
No handwriting or transcription
Protocol updated on-line

Can you think of any other benefits?

Why Aren’t All Clinical Trials Using EDC ?

The Industry Perspective

The Need to Please
 Unrealistic promises lead to unfulfilled expectations
Resistance to Change
 If it ain’t broke don’t fix it
 Not my responsibility
 Let’s dip a toe in this, but not go all the way
 Will my provider be here next year ?
 not all trials are best suited to EDC (depending on phase, and size/ geographic
 Lack of time for planning lead time for set up and training
Why Aren’t All Clinical Trials Using EDC ?

 What’s your perspective?

Who Does EDC Affect ?

NHS – Hospitals/ Primary Care Industry

 IT Support/Logistics
Project Managers
 Needs up front planning
 Data visibility
 Connectivity issues
 Clinical Monitoring Staff
 Firewall problems
 Decreased queries
 Other security issues
 Changed workflow
 Location of connectivity points
 Wireless technology security  De facto first line of support of
sites – (different skill set)
Investigator Sites:
Data Management
 Requires training initially
 No data entry
 More timely queries
 Drug Safety / Pharmacovigilance
 Decreased queries
 Reduced archiving  Automatic SAE notification

 Principal Investigator role?  IT / Application Support

 Changed skill set for site staff Modified training needs for all staff
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

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

What are the issues at Site?

 Multiple systems without electronic interface

 Network access issues for CRAs and Site staff
 Others?

What is your perspective?

Data Archiving for EDC : points to consider

What needs to be archived ?

What format ?

What medium ?
Making EDC Work
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
 Timing
 Investigator Meeting vs. Site Initiation
 Method of Training
 Method of access to support
 Meeting the needs of the End User?
 Adequate and appropriate Resourcing (out of hours/ local language support)
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
 Mixed paper-EDC study
 Site provisioning
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
User Account Setup
 The relevant accounts are created
 activated ONLY once completed training documentation has been
 Qualified sites emailed individual usernames and passwords
Site Setup :

What SHOULD the industry do to support

Site Setup - The Challenge


Source : Charles Jaffe, AstraZeneca

EDC Training

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