HHS · no agency ID · record R0857

AI for Assessing Bioanalytical Study Conduct Alignment with Guidance and Method SOPs

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: 2025-01 (month precision)Source: Jan-25
Withheld from public reporting: NoSource: a) No

Mission

Topic area: Health and Medical
Operational functions: No function tag matched Derived by keyword rules; see methodology

Problem the AI is intended to solve

Cross-comparing large amounts of bioanalytical data (reports, validation, tabulated data) with the M10 guidance and aligned method Standard Operating Procedures (SOPs) to identify all possible study conduct issues.

Expected benefits

Expedited identification of bioanalytical study conduct issues through efficient cross-comparisons between the M10 guidance, method Standard Operating Procedures (SOPs), and bioanalytical study reports/data before and during inspections, helping ensure data quality and regulatory compliance.

System outputs

Organized summary of bioanalytical study conduct deviations from M10 principles, regulations, and method SOPs, followed by a summary of potential study impact. 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