Informed Consent Process Documentation Agent

Consent paperwork errors are among the most common findings at a study audit, and they are hard to fix later. After each consent visit, this agent reads the signed form and checks the version number, participant and investigator signatures, dates, and initials. It compares the consent date to the visit log and to the first study procedure, so it can spot a procedure done before consent. For each issue it drafts a note-to-file. The coordinator and principal investigator decide the correction. After the corrections are filed, it rechecks the form and the log. Edge case: the form version is current but a newer one was approved the week before, so the agent flags that the participant signed an outdated version.