When Is an Electronic Signature “Good Enough” in a Trial?

Let’s cut through the buzz. Everyone talks about eSignatures, but few trial teams stop to ask: what actually makes an electronic signature acceptable - legally, operationally, and practically?

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Three Questions to Ask

1. Is it legally recognised?

In most jurisdictions, yes, electronic signatures are legally binding. But the key term is most. There are differences:

• In the EU, eIDAS defines tiers of eSignatures
• In the US, FDA 21 CFR Part 11 applies to clinical systems
• In some regions, handwritten signatures are still required for ethics forms

Action: Confirm what your local authority or ethics board requires. “It works in the platform” is not enough.

2. Is it auditable?

A good eSignature captures more than a click:

• Who signed
• When they signed
• What version they saw
• Whether authentication was used (e.g. SMS or password)

Without an audit trail, you do not have a compliant signature... you just have a button press.

3. Does it make sense for the participant?

The UX matters. If a participant is:

• Unsure when they are being asked to sign
• Confused by legal terms
• Unable to access the signature on their device

…then the process fails. Not because the signature is invalid, but because it is unclear.

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Best Practice Summary

• Confirm regulatory fit per region
• Use platforms that generate full audit trails
• Pair the signature with plain-language explanations
• Allow participants to preview and download what they signed
• Keep the process under 5 minutes — without rushing it

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A signature is a point of trust. Digital or physical, it should feel deliberate, traceable, and understandable.

Good enough? That depends on who is looking — and what they are looking for.

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