Proving Comprehension, Not Just Signature: eConsent with Built-In Understanding Checks
Proving Comprehension, Not Just Signature
How eConsent in Sarjen’s Smart Trial Suite for Late Phase (STS LP) gives every participant the current eICF, records what they confirmed, and completes consent before screening begins.
- How a multi-site CRO moved consent from paper to eConsent
- The 8-step consent flow in PRMS
- Paper vs. eConsent, compared point by point
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A signed form proves a signature. Not understanding.
The CRO in this case study runs Phase II–IV trials across multiple investigator sites. Its consent process was on paper: forms came from printed stock, checklists and signatures were dated by hand, and each form was matched to a participant’s screening number manually.
Gaps surfaced late, at a monitoring visit or an audit, rather than at the moment of consent.
- An outdated ICF version could be signed
- Checklists and signatures were dated by hand
- Each form was matched to the screening number manually
- Re-consent after an amendment was tracked by hand
Consent first, then screening and randomization
In Smart Trial Suite for Late Phase, eConsent runs inside PRMS, the module for patient recruitment and randomization. Every participant moves through the same eight steps, in the same order.
- 01
eICF assigned
The current approved version, in PRMS
- 02
Participant reads the eICF
On screen, at their own pace
- 03
Understanding checklist
Confirms the key points of the study
- 04
Participant signs
Or their LAR, with a witness where needed
- 05
PI signs
Consent is now complete
- 06
Screening
Follows consent, never before it
- 07
eICF mapped
To the participant's screening number
- 08
Randomization
Where the protocol requires it
Every checklist response and signature is time-stamped in a 21 CFR Part 11 and GCP-compliant audit trail.
What changes when consent moves to STS LP
The right version, every time
Each participant is assigned the current approved eICF, never a form from printed stock.
One traceable record
The checklist, every signature and the screening number, linked and time-stamped.
Consent before screening
Screening and randomization follow a consent signed by both the participant and the PI.
Faster monitoring and audits
Monitors review eICFs in one system instead of paper files at each site.
The case study includes the full eight-point comparison of paper consent and eConsent.
What you'll find in the PDF
- The challenge: what paper consent made hard to prove
- The 8-step eConsent flow in PRMS, with diagram
- Paper vs. eConsent: an eight-point comparison
- Regulatory context: FDA eIC guidance and ICH E6(R3)
- Business impact and key takeaways