FDA Qualification

PROMIS® and FDA

Multiple PROMIS measures are part of the U.S. Food and Drug Administration’s (FDA) Clinical Outcome Assessments (COA) Qualification Program.

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PROMIS Measures Can Be Used as Primary and Secondary Endpoints in Clinical and Observational Studies on the Effectiveness of Treatment

PROMIS can measure symptomatic adverse events, physical function, and disease-related symptoms (e.g., dyspnea). Kluetz and colleagues (2016) recommended assessing these domains in cancer clinical trials.

Healthcare-professional-assessing-hand-and-upper-extremity-physical-function-in-an-adult-patient-representing-FDA-qualified-PROMIS-short-forms used-to-measure-fatigue-in-rheumatoid-arthritis-and-physical-function-in-advanced-cancer

PROMIS Short Forms Qualified by FDA

Two PROMIS short forms have been accepted by the COA Qualification Program at the FDA.

PROMIS Short Form v1.0 – Fatigue 10a has been qualified for use with adult patients with rheumatoid arthritis (DDT COA #000015).
PROMIS Short Form v2.0 – Physical Function 8c has been qualified for use with adult patients with advanced cancer (DDT COA #000079).

Qualification Status of PROMIS Measures

For more information, contact us at help@HealthMeasures.net or visit the FDA’s Clinical Outcome Assessment webpage.

Patient Population	PROMIS Measure	Qualification Stage	Qualification Status	DDT COA #
Sarcopenia	PROMIS Bank – Physical Function	Qualification Plan (QP)	In Development	DDT COA #000085
Rheumatoid Arthritis	PROMIS Short Form – Fatigue 10a	Full Qualification Package (FQP)	Qualification Accepted	DDT COA #000015
Oncology	PROMIS Short Form v2.0 – Physical Function 8c	Full Qualification Package (FQP)	Qualification Accepted	DDT COA #000079
Chronic Fatigue Syndrome (CFS) Myalgic Encephalomyelitis (ME) Systemic Exertion Intolerance Disease (SEID)	PROMIS Bank v1.0 – Fatigue	Qualification Plan (QP)	In Development	DDT COA #000080
Multiple Sclerosis (MS)	PROMISnq Short Form v2.0 – Physical Function-Multiple Sclerosis 15a	Qualification Plan (QP)	In Development	DDT COA #000123
Multiple Sclerosis (MS)	PROMIS Short Form v1.0 – Self-Efficacy for Managing Symptoms 8a	Qualification Plan (QP)	In Development	DDT COA #000069

U.S. Food & Drug Administration. (n.d.). CDER & CBER Drug Development Tool Qualification Project Search. Retrieved September 29, 2026, from https://force-dsc.my.site.com/ddt/s/.

Patient Population	PROMIS Pediatric Measure	Qualification Status	Qualification Status	DDT COA #
Pediatric patients with Chronic Kidney Disease	PROMIS Pediatric Bank – Fatigue	Qualification Plan (QP)	In Development	DDT COA #000095
Pediatric patients with Chronic Kidney Disease	PROMIS Pediatric Bank v1.0 – Sleep Disturbance	Qualification Plan (QP)	In Development	DDT COA #000119
Pediatric patients with Crohn’s Disease	PROMIS Pediatric Bank – Fatigue	Qualification Plan (QP)	In Development	DDT COA #000092

U.S. Food & Drug Administration. (n.d.). CDER & CBER Drug Development Tool Qualification Project Search. Retrieved September 29, 2026, from https://force-dsc.my.site.com/ddt/s/.

What is the Clinical Outcome Assessment (COA) Qualification Program?

The FDA recognizes the importance of research tools that aid the development and evaluation of medical treatments. These tools include performance measures of function and patient-reported outcome measures (PROMs) that may serve as clinical outcome assessments (COAs) in clinical trials. To expedite the use of a specific PROM as an outcome in clinical trials, a person or group may submit the PROM for qualification by a center of the FDA, e.g., the Center for Drug Evaluation and Research (CDER). Qualification is a multi-step process that requires substantial qualitative and quantitative evidence to support the reliability, validity, and interpretability of the PROM for its intended use. Once a PROM has been qualified, FDA reviewers can be confident that it is valid for its specific context of use, e.g., assessing the effect of treatment relative to placebo on fatigue in children with Crohn’s disease aged 8-17 years old. Hence, the PROM may be employed in drug development trials within the context of use without the need for further review of its validity.

Steps in Qualification Process

There are multiple steps in the qualification process. At each stage, FDA reviewers provide feedback and may request revisions and additional information.

Learn More

01

Letter of Intent

Submit a Letter of Intent that describes the PROM and its preliminary supporting evidence.

02

Qualification Plan

Submit a Qualification Plan that provides detailed information about a) qualitative research conducted with the intended patient population and b) plans for further research.

03

Final Qualification Package

Submit a Full Qualification Package with data and results supporting the PROM as well as instructions for administration, scoring, handling missing data, and interpreting scores.

PROMIS Measures in Label Claims

PROMIS measures are used as primary and secondary endpoints in clinical studies on the effectiveness of treatment.
When there is sufficient evidence that a treatment has a meaningful impact on outcomes relevant to patients, the package insert for that treatment can “claim” that benefit.
This means that the FDA recognizes this benefit of the treatment.
For example, patients receiving ROMVIMZA for tenosynovial giant cell tumor reported clinically meaningful improvement in physical function. This was demonstrated with a PROMIS Physical Function short form. See PROMIS Case Studies for more detail.