> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Imaging Endpoint Process Standard Guidance
- URL: https://www.fdaweb.com/imaging-endpoint-process-standard-guidance/
- Published: 2018-04-26T12:00:00.000Z
- Updated: 2026-09-15T00:01:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141306

FDA has issued a guidance, *Clinical Trial Imaging Endpoint Process Standards*, to assist sponsors in optimizing the quality of imaging data obtained in clinical trials intended to support approval of drugs and biologic products. The [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM268555.pdf?ref=fdaweb.com) focuses on imaging acquisition, display, archiving, and interpretation process standards that the agency says it considers to be important when imaging is used to assess a trial’s primary endpoint or a component of that endpoint.

Imaging process standards help sponsors ensure that imaging data are obtained in a manner that complies with a trial’s protocol, that the quality of imaging data is maintained within and among clinical sites, and that a verifiable record of the imaging process is created, FDA says.

The guidance says that while standardization is important for all clinically used measures, it becomes essential for an imaging endpoint used in a clinical trial to reduce variability and to ensure interpretability of the results. The document does not address approaches for selecting an imaging endpoint for a clinical trial. It also does not address whether specific imaging measures would be acceptable in submissions used to support approval of a drug or biologic.