Rule pack · Healthcare & Life Sciences
Clinical Regulatory Compliance Pack
A starter rule pack covering two of the most-audited compliance requirements in clinical research: informed consent documentation and adverse event reporting. Aligned to ICH-GCP standards.
Works on
- Clinical Study Reports
- Regulatory Submissions
A starter template, configured with you during onboarding and adapted to your standards.
Rules
2 rules, each with a severity you set
| Rule | Severity | What it checks |
|---|---|---|
| Informed Consent Documented | critical | Confirms ICF references |
| Adverse Events Reported | high | Detects AE/SAE reporting |
Rules return a result with the evidence behind it, for a reviewer to act on. They are deterministic checks you configure, not compliance decisions.
Related templates
- Rule packContract Compliance Rule PackRed/amber/green rule results across contract portfolios, for reviewer sign-off.
- Rule packPolicy Adequacy Compliance PackRule-pack checks you define for commercial insurance policies.
- Extraction templateClinical Trial Data ExtractionStandard data extraction for clinical trial reports.
Adapted to your documents at onboarding
Templates are configured with you during the Founding Customer pilot.