Beruflich Dokumente
Kultur Dokumente
Our definition for EDC is any electronic data capture including electronic patient
notes, IVR systems, eCRFs, patient diaries, Centralised lab reporting, etc, etc
Data Project
Manager Manager
CRA
Queries/ Database
DCFs
Data
Entry
Investigator
CRFs
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
Quality
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
Quality
Delayed Data validation
Clarity of Patient eligibility
Inconsistencies of handwriting
transcription
Data
Manager Project
Manager
CRA
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
Quality
On-line data & patient validation
No handwriting or transcription
problems
Protocol updated on-line
EDC Trials – Benefits for Sites
Time Cost
Quicker query resolution Reduced Paperwork?
Faster database lock Less Review time with
CRA?
Quality
On-line data & patient validation
No handwriting or transcription
problems
Protocol updated on-line
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
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)
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
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
Site Setup :
6
1
5
2
3
4
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
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