FMRP 2016 | 1
Marc Bosiers Koen Deloose Joren Callaert
A.Z. Sint-Blasius, Dendermonde
Imelda Hospital, Bonheiden
Patrick Peeters Jürgen Verbist
Wouter Van den Eynde
OLV Hospital, Aalst
Lieven Maene Roel Beelen
R.Z. Heilig Hart, Tienen
Koen Keirse Bart Joos
Electronic Data Capture: Is there an easy way for
physician initiated research?
Marc Bosiers, MD
LINC 2016, Leipzig
FMRP 2016 |
Physician initiated research
2
FMRP 2016 |
Clinical Research : What is important?
• Protocol
• Patients
• Study momentum: enrollment
• Good Clinical DATA!
– Improves credibility of study
– Improves journal acceptance
3
FMRP 2016 |
What challenges face physician investigators?
• Collecting data accurately and easily
• Maintaining study quality and compliance
• Keeping within budget
• Maintaining study momentum and enthusiasm across sites
– Impacts enrolment rates
– Impacts quality of data collected
A good data collection tool can address many challenges!
4
FMRP 2016 |
How it was done…
5
Paper CRF
Day 0 Patient visits
hospital
Day 91 Transfer of
pCRFs to DM
Day 1 Data entry
in pCRF
Day 0 - 90 Continuing
enrolment
Day 90 Monitoring &
collection
Day 93 Data entry 2
Day 92 Data entry 1
Day 125 Database lock
Day 94 - 124 Data
management
Day 125 - 139 Statistics
FMRP 2016 |
With known disadvantages
6
Lost time
Entering data
multiple times
Risk of entry
errors Paper storage
Shipment of data
FMRP 2016 |
New approach ….. technology
7
Immediate access to your data & 20% faster in getting your final report
Day 0 Patient visits
hospital
Day 1 Data entry
in eCRF
Day 0 - 90 Continuing
enrolment &
ongoing data
management
Day 90 On-site
monitoring
Day 91 - 101 Data
Management
Day 101 Database lock
Day 101 - 115 Statistics
FMRP 2016 |
FMRP selection criteria for EDC
8
• Easy to set up
• Easy to use for clinical sites
• Flexible in case of amendments
• Edit / validation checks in system
• Notifying e-mail when new subject is enrolled
• Create Queries
• Simple Data Extraction
• Transparent pricing: budgeting
edc2go ® is a genae product: www.edc2go.com
FMRP 2016 |
Easy to set up – create CRF
9 edc2go ® is a genae product: www.edc2go.com
ADD new question and customize to your own
specific needs
FMRP 2016 |
Easy to set up – invite centers and users
10 edc2go ® is a genae product: www.edc2go.com
ADD centers easily
ADD users with different roles
FMRP 2016 |
Easy to use for clinical sites
11
Clear overview of different subjects,
visits and forms
FMRP 2016 |
Flexible in case of amendments
12
Create a new version, based on a previous one
FMRP 2016 |
Edit / validation checks
13 edc2go ® is a genae product: www.edc2go.com
Add validation rules to minimize data entry errors and missing data
FMRP 2016 |
Notifying e-mail
14
FMRP 2016 |
Create Queries
15
Simple and clear to Make Queries
FMRP 2016 |
Simple Data Extraction
16 edc2go ® is a genae product: www.edc2go.com
Create reports or export full data
FMRP 2016 |
Transparant pricing
17
Fixed prices, to allow budgeting (research grants)
edc2go ® is a genae product: www.edc2go.com
FMRP 2016 |
Advantages of
18
• One time data entry
• Credibility of data
• Regulatory compliance
• Data availability for publications
• Source data upload
• Grant provider can have access
• Automated edit checks
• Security of the database
FMRP 2016 |
Conclusion
19
Very intuitive
User-friendly
High-quality data
Prompt study results
Very interesting price
