Consent forms that are compliant and actually readable.
Asthra drafts adult and pediatric Informed Consent Forms from your protocol and IB — covering every 21 CFR 50 and EU CTR element, in genuine lay language. Pediatric studies get parallel parental-permission and age-banded assent versions, each at the right reading level.
What you bring to the draft.
Asthra derives the consent content from the study documents that govern it.
Trial Protocol
Procedures, schedule, duration, and eligibility — the basis for what participants are told will happen.
Investigator's Brochure
Safety and efficacy data — the source for known and potential risk disclosures.
Risk Assessment
For pediatric studies, the Subpart D risk categorisation that gates assent requirements.
Data Governance Policy
GDPR / HIPAA terms, future-use, and genomic-data notices for the confidentiality sections.
Site / IRB Template
Asthra writes into your site or sponsor template — required headings and language preserved.
Compensation / Injury Terms
Cost, compensation, and research-injury provisions for the relevant CFR / CTR sections.
From protocol
to a full consent set.
Upload & classify
Drop your protocol, IB, risk assessment, and site template into the project. Asthra classifies each and identifies whether pediatric versions are needed.
Approve the plan
Asthra proposes the regulatory framework (CFR / Common Rule / EU CTR), the version set, and the reading-level targets. Approve once.
Generate the first draft
Asthra drafts each version in lay language, derives risk statements from the protocol and IB, and produces age-banded assent forms. Gaps flag where a required element lacks a source.
Writer review in Word
Refine wording, adjust the reading level, or run a reviewer persona for an IRB-style completeness check in the task pane. Every change is logged.
Hand off to the IRB
The set ships with the audit ledger embedded — every risk statement resolves to its source in the protocol or IB.
What changes for the consent team.
Manual ICF drafting
- −Risk statements copied from the IB and re-worded by hand
- −Pediatric versions written separately, drifting from the adult form
- −Reading level checked manually, if at all
- −Cross-jurisdiction consistency (CFR vs CTR) tracked by memory
- −Completeness against required elements verified by checklist
ICF drafting with Asthra
- +Risk statements derived from the protocol and IB, traceable
- +Adult and pediatric versions generated together, kept consistent
- +Reading level targeted per version automatically
- +Regulatory framework applied as the authoring ruleset
- +End-of-run QC confirms every required element is present
Pilot Asthra
on a real consent set.
30-day pilot. Bring one protocol. We'll match Asthra's consent set — adult and pediatric — against your existing process.