Informed Consent Authoring demo
Drafts the master and every country consent form from the protocol and the brochure, traces each statement to its source and writes it at a grade-8 reading level. 1:10
What the demo shows
A clinical trial solution for study teams that drafts consent forms and checks readability.
Reads the protocol and the Investigator's Brochure, drafts the master consent section by section, ties every statement to its source, proposes plain-language rewrites, checks US and EU required elements, and carries each change into every country, site and special form as tracked changes. When an amendment arrives, the consent family shows which sentences in which forms must change, each form's new reading grade and each ethics committee's clock.
Transcript
- Informed Consent Authoring Drafts trial consent forms from the protocol for study teams.
- 9 in 10 consent forms read above grade 8.
- Amendment 3 arrives. Lines run from the master to 12 forms, each turning amber with its new reading grade.
- Germany. 13 sentences to change, 16 days left.
- Lena drafts the master.
- Seven agents trace every statement to its source.
- One still says 12 visits.
- The protocol says 13.
- She applies the fix.
- Ten plain language rewrites take the master from grade 8.5 to 6.8.
- Eleven country forms are written as track changes.
- Germany now reads at grade 6.9.
- Built on Botminds: agents, data, screens, and governance on one platform.
Transcribed from the film’s narration. Captions are on the player.