What to look for in eConsent software.

Start with the signature record

The signature is the part people notice, but the record behind it matters more. Ask what's captured when a subject signs, who can see that record, and whether you can review it alongside the consent version that was signed.

Questions to ask about versions

• Does each version carry its IRB approval reference, effective date and language?
• Can you see the current version and what it replaced?
• Can you report who signed which version, and when?

Informed consent forms often change during a study, so version control is where a paper log tends to struggle most.

What happens when a new version arrives

Releasing a new ICF sets off work: someone has to find every subject who signed an earlier version and make sure they're re-consented if required. Ask whether the software flags those subjects and raises a follow-up task, or leaves your team to work it out.

Does it connect to visits?

A consent record that sits apart from the visit schedule still depends on someone checking it. Ask whether the system can stop a visit from being saved when the required consent isn't on file, and whether that attempt is recorded.

Questions for your sponsor and IRB

Software is only part of the decision. Before using eConsent on a study, check that your sponsor and IRB accept the approach, and that the content subjects see matches what was approved. Requirements differ by study, so confirm them early.

Don't forget the subject

Consent is a conversation, and electronic signing doesn't replace it. Your team still needs time to answer questions, and each subject still needs a copy. Make sure you can record that the copy was delivered.

Where PAS OneCore fits

Our eConsent software for research sites covers electronic signing with a security audit trail, an ICF version registry, re-consent tracking and visit blocking.

Have a study coming up?

Tell us how your site handles consent now, and we'll show you how it would work in PAS OneCore.