esouce data for clinical trials
TRANSCRIPT
Timely data review by the principal inves4gator
Timely data review by sponsor safety
reviewers
Automated system queries for real-4me data quality checking
Faster availabilityof data
Accurate and complete audit trail
and 4mestamps
Reduced volume of records to be source
data verified
Easier remote monitoring
Eliminate unnecessary duplica4on of data
Reduce opportunity for transcrip4on
errors
Promote the real-4me entry of electronic source data during
subject visits
Ensure the accuracy and completeness
of data
Instant safety review to protect human
health
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The Main Benefits of eSource
Tradi4onal Source vs eSource
Sources:1. How eSource is Transforming RbM, Apr 17, 2015, Moe Alsumidaie, Applied Clinical Trials2. eSource Implementa4on in Clinical Research: A Data Management Perspec4ve, SDCM 2014, June 12, 20143. The High Cost and Ques4onable Impact of 100% SDV,The CenterWatch Monthly, February 2011
EDCdatapa4ent
1
VS
• eCRF accessible on the spot• No SDV required• Data error no4fica4ons• Autoquery
2
EDCdatapa4ent
sourcetranscrip4onsource
datasource dataverifica4on
2
The Challenges of SDV
SDV costs can add up to 34% of the total
study cost 3
83% of sponsors report always
verifying CRF data against source data
Up to 50% of site source records are s4ll maintained on paper
3