Intended use
This tool helps CRAs and clinical research teams draft reports, search FDA/ICH reference material, use operational tools, and access learning content. Outputs should be treated as working drafts or reference support.
Privacy, safety, and responsible use
Privacy & Disclaimer
CRA AI Assistant is designed to support clinical research operations. It does not replace protocol requirements, sponsor SOPs, regulatory obligations, medical judgment, or professional review.
Do not enter PHI or sensitive subject data
Do not enter patient names, initials, dates of birth, medical record numbers, addresses, phone numbers, emails, or other direct identifiers. Use subject codes and de-identified operational notes whenever possible.
AI and regulatory disclaimer
AI-generated report text and Q&A responses may be incomplete or incorrect. Always verify against the approved protocol, investigator brochure, monitoring plan, sponsor SOPs, source records, IRB/IEC requirements, and official FDA/ICH documents.
Data handling
The cloud app may process text you submit in order to provide requested features. Do not submit confidential sponsor materials or regulated personal data unless you have authorization and have confirmed the appropriate data protection requirements.
User responsibility
Users are responsible for reviewing, editing, and approving any generated content before use. Clinical, regulatory, safety, and reporting decisions should remain with qualified study personnel and the responsible organization.
Contact
For clinical operations support or questions about this assistant, contact Clarity Clinical Solutions through the main website.
Use the assistant carefully
When in doubt, rely on the protocol, sponsor instructions, and official regulatory sources first.