What stays the same
Source is still the original record of what happened at a visit, and staff still follow the protocol. The expectations behind good documentation don't change either: records should show who did what and when, and stay accurate and available. Only the place the record lives is different.
What changes day to day
- Templates: source is built ahead of time from the schedule of activities, so the template needs review before the first visit.
- Corrections: instead of a single-line strike-through with initials, a change is recorded with its reason, and the original value is kept.
- Finding records: staff can look up a subject's visit without pulling a chart.
- Monitor review: monitors can look at records through their own access rather than working through paper at the site.
How to plan the switch
- Start with a new study rather than moving one that's already underway
- Check with the sponsor or CRO, since they may need to review your eSource approach
- Have a coordinator test the template against a mock visit
- Agree on a downtime plan, so visits can continue during an outage
- Decide how and when data gets moved into the sponsor's EDC
Don't confuse it with EDC
An EDC is usually the sponsor's system for collecting study data from every site. eSource is the site's original record. Many sites use both, so plan for how the two will work together. Our guide to what eSource is covers the difference.
Where PAS OneCore fits
Our eSource software for research sites builds versioned templates from the schedule of activities, keeps each amendment with its reason, and prints blank worksheets for outages.
Thinking about moving off paper?
Tell us about your next study, and we'll talk through what a switch would involve.
Talk to us