HHS · no agency ID · record R0856

AI for Clinical Study Risk Assessment and Inspection Preparation

Department of Health and Human Services · HHS/FDA/CDER

Overview

Development stage: PilotSource: b) Pilot – The use case has been deployed in a limited test or pilot capacity.
High-impact designation: Not high-impactSource: c) Not high-impact
Impact justification: Not reported
Start date: 2025-06 (month precision)Source: Jun-25
Withheld from public reporting: NoSource: a) No

Mission

Topic area: Health and Medical
Operational functions: Clinical and medical Derived by keyword rules; see methodology

Problem the AI is intended to solve

Challenges in assessing large amounts of clinical study information for risk assessment and inspection planning in a short period of time

Expected benefits

Efficient and thorough review of clinical portions of pivotal studies, enabling risk assessors and reviewers to identify and address potential issues. This benefit promotes public health by protecting study subjects, and by helping the office verify the quality, study integrity, and regulatory compliance of Bioavailability/Bioequivalence (BA/BE) studies supporting CDER-regulated drugs.

System outputs

Summary including any inconsistencies, discrepancies, missing information, protocol deviations, unforeseen circumstances, unexpected adverse events, severe or serious adverse events, and modifications to processes or procedures; description of potential impact on study outcome. Outputs are verified by FDA staff.

Technology

AI classification: Generative AISource: Generative AI: AI that generates new or synthetic content (e.g., images, videos, audio, text, code).
System name(s): Elsa
Custom-developed code: No
Public source code: Not reported

Sourcing

How it was built: Developed in-houseSource: b) Developed in-house
Vendor (as reported): Not reported
Vendors (standardized): None on the standard list

A vendor is the supplier named by the agency. It does not identify the underlying model or AI technology.

Data and privacy

Involves PII: No
Privacy Impact Assessment: Not reported
Authorization to Operate: Yes
Demographic features: k) None of the above
Training and evaluation data: No FDA data were used to train, fine-tune or evaluate
Federal Data Catalog: Not reported

Governance

0 of 8 minimum-practice questions answered. A blank answer means the agency reported nothing; it does not mean the practice is absent.

Pre-deployment testingNo answer reported

AI impact assessmentNo answer reported

Independent reviewNo answer reported

Ongoing monitoringNo answer reported

Operator trainingNo answer reported

Fail-safeNo answer reported

Appeal processNo answer reported

User and public consultationNo answer reported

Potential impacts and how they were identified

Not reported