Informed consent, with the version history attached to every patient.
Consent is not a document, it is a state — this patient, on this ICF version, signed on this date. When the protocol is amended that state changes for part of your cohort, and someone has to know exactly which part.
- ICF versioning
- E-signature
- Re-consent flags
- Audit trail
- Signed on current version
- 134
- Pending first consent
- 18
- Re-consent required
- 8
- Withdrawn
- 2
The same view a CRA opens when preparing a monitoring visit.
Most consent deviations are structurally impossible here.
Wrong version, wrong date, wrong signatory — the three consent findings that recur at almost every inspection, each one a consequence of consent being recorded away from the rest of the trial.
Only delegated staff can take consent
The delegation log gates it. The most common consent finding, removed at source.
No date errors
Timestamps are system-captured, so a consent cannot be misdated or dated before ICF approval.
No version errors
Consent is offered against the version currently approved for that site, from the submission record.
Re-consent cannot be forgotten
An amendment flags every affected patient. The flag clears only on a signature against the new version.
Signatures are attributable
Bound to an authenticated individual, recording signer, date, meaning of signature and ICF version.
The trail is tamper-evident
Append-only trail with actor, timestamp and reason. Built to support 21 CFR Part 11 and Annex 11 workflows.
What happens when ICF v3.1 is approved.
An approved submission lands in the platform once and becomes the truth the rest of the system reads. That is why approving a new ICF version does not start a distribution exercise — everything below simply follows from the same record.
- Patients8 patients flagged for re-consent
- SitesSite 04 and Site 07 notified
- eTMFNew version filed, v3.0 superseded
- Site fileISF index updated at every active site
- MonitoringConsent review added to the next IMV
- Audit trailVersion change recorded with actor and reason
Consent as an operational record.
Version control
Every ICF version retained, with effective dates and what it superseded.
Patient e-signature
Signature captured with actor, timestamp and the version presented.
Per-patient status
Consent state on the patient record, visible wherever that patient appears.
Re-consent tracking
Raised on amendment, cleared only by a signature on the current version.
Site-level view
Coordinators see their own outstanding consents without asking the sponsor.
Automatic filing
Signed forms and version history file to the eTMF and site file.
Common questions
What happens when the ICF is amended mid-study?
The new version is loaded and every enrolled patient is evaluated against it. Those who consented on an earlier version are flagged for re-consent, with the flag visible to the site, to the CRA preparing the next monitoring visit, and in the study-level view. The flag clears only when a signature against the current version is recorded.
Does MonitoHQ support remote consent?
Consent can be signed on site or remotely. Either way the record captures who signed, which ICF version, when, and by what method, and the signed document is filed against the patient.
What does the audit trail record?
Every consent event — version presented, signature captured, re-consent triggered, document superseded — with actor, timestamp and reason where one applies. The trail is exportable alongside the rest of the platform's audit record.
Is this 21 CFR Part 11 compliant?
Compliance is a property of your validated implementation and your procedures, not of software alone. MonitoHQ provides the technical capabilities Part 11 workflows rely on — unique attributable e-signatures, a time-stamped and non-editable audit trail, version control and role-based access — and we support your validation. We do not claim that using MonitoHQ makes a sponsor or site compliant.
Can a site still use paper consent for some patients?
Yes. A paper ICF can be scanned in and recorded against the patient with its version and signature date, so the consent status view stays complete even in a mixed-mode study.
Connected in the same platform
Bring an ICF amendment you've lived through.
30 minutes with a founder. We'll take a real amendment and show what re-consent looks like when consent status is a live record rather than a spreadsheet.