ClinicalTrials.gov Protocol Registration and Results System Review Assistant

Section 1: Use Case Identifiers

Use Case ID: HHS-NIH-00020
Agency: HHS
Op Div/Staff Div: NIH
Use Case Topic Area: Government Services (includes Benefits and Service Delivery)
Is the AI use case found in the below list of general commercial AI products and services?
None of the above.
What is the intended purpose and expected benefits of the AI?
ClinicalTrials.gov is a website and online database of clinical research studies and information about their results. The purpose of ClinicalTrials.gov is to provide information about clinical research studies to the public, researchers, and health care professionals.

This project aims to help ClinicalTrials.gov determine whether the addition of AI could make reviewing study records more efficient and effective.
Stage of Development: Acquisition and/or Development
Is the AI use case rights-impacting, safety-impacting, both, or neither?
Neither

Section 2: Use Case Summary

Date Initiated: 02/2021
Date when Acquisition and/or Development began: 11/2021
Date Implemented: N/A
Date Retired: N/A
Was the AI system involved in this use case developed (or is it to be developed) under contract(s) or in-house?
Developed with contracting resources.
Provide the Procurement Instrument Identifier(s) (PIID) of the contract(s) used.
GSA Contract # GS-10F-0064W NLM BPA Task Order: 75N97019A00005/75N97021F00006
Is this AI use case supporting a High-Impact Service Provider (HISP) public-facing service?
N/A
Does this AI use case disseminate information to the public?
N/A
How is the agency ensuring compliance with Information Quality Act guidelines, if applicable?
N/A
Does this AI use case involve personally identifiable information (PII) that is maintained by the agency?
N/A
Has the Senior Agency Official for Privacy (SAOP) assessed the privacy risks associated with this AI use case?
ongoing

Section 3: Data and Code

Do you have access to an enterprise data catalog or agency-wide data repository that enables you to identify whether or not the necessary datasets exist and are ready to develop your use case?
No
Is there available documentation for the model training and evaluation data that demonstrates the degree to which it is appropriate to be used in analysis or for making predictions?
Documentation is complete
Which, if any, demographic variables does the AI use case explicitly use as model features?
N/A
Does this project include custom-developed code?
N/A
Does the agency have access to the code associated with the AI use case?
N/A
If the code is open-source, provide the link for the publicly available source code.
N/A

Section 4: AI Enablement and Infrastructure

Does this AI use case have an associated Authority to Operate (ATO) for an AI system?
No
System Name: N/A
How long have you waited for the necessary developer tools to implement the AI use case?
Less than 6 months
For this AI use case, is the required IT infrastructure provisioned via a centralized intake form or process inside the agency?
Yes
Do you have a process in place to request access to computing resources for model training and development of the AI involved in this use case?
Yes
Has communication regarding the provisioning of your requested resources been timely?
Yes
How are existing data science tools, libraries, data products, and internally-developed AI infrastructure being re-used for the current AI use case?
Use of existing data platforms
Has information regarding the AI use case, including performance metrics and intended use of the model, been made available for review and feedback within the agency?
Limited documentation for review