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  1. Clinical Outcome Assessment (COA) Qualification Program

Clinical Outcome Assessments (COA) Qualification Program Submissions

The tables below list information about submissions to the FDA Clinical Outcome Assessments (COA) Qualification Program for which final COA qualification determinations have not yet been made. The tables include legacy projects (those submitted prior to enactment of the 21st Century Cures Act), as well as those submitted as part of the newer section 507 process (referring to section 507 of the Federal Food, Drug and Cosmetic Act (FD&C Act), which was created by Section 3011 of the 21st Century Cures Act). These tables only include documents from requestors that were received after the passage of the 21st Century Cures Act. The tables are updated on a biannual basis and provide information on the COA qualification project, including FDA’s decision to accept or not accept the submission, and FDA’s recommendations on further COA development.

FDA’s posting of information submitted to the Agency by outside parties requesting qualification of a drug development tool is not an endorsement or recommendation by FDA of the tool’s use. Information about submissions is made publicly available in accordance with section 507 of the FD&C Act. The FDA makes no representations, guarantees, or warranties as to the accuracy, completeness, currency, or suitability of the information in submissions. See the FDA decision letter corresponding to each submission for FDA considerations and recommendations related to each request for qualification.

To view qualified COAs, please visit: Qualified Clinical Outcome Assessments (COAs).

Cardiology, Hematology, Endocrinology, and Nephrology (OCHEN)
Division of Cardiology and Nephrology (DCN)

Disease/ConditionDDT COA Number and Instrument NameConcept of InterestContext of UseCOA TypeQualification
Stage
Chronic Heart Failure (CHF)DDT COA #000112: Chronic Heart Failure- Symptom Scale (CHF-SS)CHF symptomsPatients with CHFPROLetter of Intent- Accepted
Chronic Heart Failure (CHF)DDT COA #000113: Chronic Heart Failure- Impact Scale (CHF-IS)CHF symptom impactsPatients with CHFPROLetter of Intent- Accepted
Chronic Heart Failure (CHF)DDT COA #000114: Chronic Heart Failure- Activity Monitor-Based Endpoint MeasureDaily physical activityPatients with CHFDHT- Passive Monitoring COALetter of Intent- Accepted
Chronic Kidney Disease (CKD)DDT COA #000095: PROMIS® Pediatric Chronic Kidney Disease Short Form- FatigueFatigueChildren (8-17 years) with CKDPROLetter of Intent- Accepted
Chronic Kidney Disease (CKD)DDT COA #000119: PROMIS® Pediatric Chronic Kidney Disease Short Form- Sleep DisturbanceSleep DisturbanceChildren (8-17 years) with CKDPROLetter of Intent- Accepted
Varicose VeinsDDT COA #000056: Varicose Vein Symptom Questionnaire (VVSymQ)Varicose vein symptomsPatients with superficial venous incompetencePROIn legacy process*

*Under review prior to the passage of the 21st Century Cures Act

Division of General Endocrinology (DGE)

Disease/ConditionDDT COA Number and Instrument NameConcept of InterestContext of UseCOA TypeQualification
Stage
Hip fractureDDT COA #000037: Short Physical Performance Battery (SPPB)Lower-extremity functional declineAdult patients (>65 years) who have diminished muscle mass, muscle strength and decreased function as a result of hip fracturePerfOLetter of Intent- Accepted
SarcopeniaDDT COA #000085: PROMIS®  Physical Functioning in SarcopeniaPhysical functioningPatients with sarcopeniaPROLetter of Intent- Accepted
SarcopeniaDDT COA #000105: Actibelt® in SarcopeniaChange in real-world walking speedPatients with sarcopenia in recovery after surgical treatment of hip fractureDHT- Passive Monitoring COALetter of Intent- Accepted

Division of Nonmalignant Hematology (DNH)

Disease/ConditionDDT COA Number and Instrument NameConcept of InterestContext of UseCOA TypeQualification
Stage
Sickle Cell Disease (SCD)DDT COA #000057: Sickle Cell Pain DiaryPain intensity and pain interferencePediatric patients with SCDPROLetter of Intent- Accepted

Division of Diabetes, Lipid Disorders, and Obesity (DDLO)

Disease/ConditionDDT COA Number and Instrument NameConcept of InterestContext of UseCOA TypeQualification
Stage
ObesityDDT COA #000036: Impact of Weight on Quality of Life- Lite (IWQOL-Lite) Clinical Trials VersionWeight-related quality of life concepts
  • Adult patients with obesity and no weight-related comorbidities and
  • Adult patients who are overweight or obese with >1 weight-related comorbidity
PROLetter of Intent- Accepted

Office of Neuroscience (ON)
Division of Neurology I (DNI)

Disease/ConditionDDT COA Number and Instrument NameConcept of InterestContext of UseCOA TypeQualification
Stage
Alzheimer’s DiseaseDDT COA #000004: PerfO to assess instrumental activities of daily living (IADLs)Day to day functioningAdults (>45 years) with mild cognitive impairment due to Alzheimer’s DiseasePerfOLetter of Intent- Accepted
Duchenne Muscular Dystrophy (DMD)DDT COA #000103: ActiMyo®Daily motor activityChildren, adolescent, and adult patients (> 5 years old) with DMDDHT- Passive Monitoring COALetter of Intent- Accepted
Duchenne Muscular Dystrophy (DMD)DDT COA #000104: Duchenne Video AssessmentQuality of movementAmbulatory patients > 4 years old with DMDClinROLetter of Intent- Accepted
DystrophinopathyDDT COA #000032: Abilities Captured through Interactive Video Evaluation (ACTIVE)-seatedFunctional reaching volume (FRV) intended to encompass upper extremity and trunk movementChildren (>4-12 years) and adolescents (12-17 years) and adults with Duchenne muscular dystrophy (DMD) or Becker muscular dystrophy (BMD)PerfOLetter of Intent- Accepted
Facioscapulohumeral muscular dystrophy (FSHD)DDT COA #000090: Facioscapulohumeral Composite Functional Outcome Measure (FSHD-COM)Physical functioningPatients with FSHDPerfOLetter of Intent- Not Accepted
Huntington’s Disease (HD)DDT COA #000129: Advanced Gait AnalysisProgressive gait abnormalityAmbulatory adults with pathogenic genetic mutation and CAG expansion indicative of HDDHT- Passive Monitoring COALetter of Intent- Not Accepted
Parkinson’s Disease (PD)DDT COA #000142: Virtual Motor Exam for Parkinson’s Disease, Part III Estimator (VME Part III)Motor symptom severityAdults diagnosed with Parkinson’s DiseaseDHT- Passive Monitoring COALetter of Intent- Not Accepted

Division of Neurology II (DN II)

Disease/ConditionDDT COA Number and Instrument NameConcept of InterestContext of UseCOA TypeQualification
Stage
Multiple Sclerosis (MS)DDT COA #000053: Symbol Digit Modalities Test (SDMT)Processing speedAdults with a diagnosis of MS and a relapsing-remitting (RRMS), secondary progressive (SPMS), or primary progressive (PPMS) clinical coursePerfOQualification Plan- Accepted
Multiple Sclerosis (MS)DDT COA #000069: Fatigue PRO in Multiple SclerosisPhysical functioningPatients with MSPROLetter of Intent- Accepted
Multiple Sclerosis (MS)DDT COA #000106: Actibelt® in MSChange in real-world walking speedPatients with MSDHT- Passive Monitoring COALetter of Intent- Accepted
Multiple Sclerosis (MS)DDT COA #000123: Physical Function PRO in Multiple SclerosisPhysical functioningPatients with MSPROLetter of Intent- Accepted

Division of Psychiatry (DP)

Disease/ConditionDDT COA Number and Instrument NameConcept of InterestContext of UseCOA TypeQualification
Stage
Major Depressive Disorder (MDD) DDT COA #000108: Symptoms of Major Depressive Disorder Diary (SMDDD) Depression symptom severity Adults with MDD with a 24-hour recall period PRO Letter of Intent- Accepted 
Major Depressive Disorder (MDD) DDT COA #000109: Symptoms of Major Depressive Disorder Momentary Assessment (SMDDMA) Depression symptom severity Adults with MDD “at this moment” PRO Letter of Intent- Accepted 
Major Depressive Disorder (MDD)DDT COA #000122: Telemedicine-based Administration of the Montgomery-Asberg Depression Rating Scale (MADRS)Signs and symptoms of depressionAdults (18-65 years) with MDD treated in an ambulatory setting and who have experienced a major depressive episode within the previous 6 monthsClinROLetter of Intent- Not Accepted
SchizophreniaDDT COA #000107: Virtual Reality Functional Capacity Assessment Tool (VRFCAT)Functional capacity Patients with schizophrenia PerfO Letter of Intent- Accepted 
SchizophreniaDDT COA #000115: EPICOG-SCHCognitive impairmentPatients with schizophrenia PerfO Letter of Intent- Accepted 

Division of Anesthesiology, Addiction Medicine, and Pain Medicine (DAAP)

Disease/ConditionDDT COA Number and Instrument NameConcept of InterestContext of UseCOA TypeQualification
Stage
Alcohol use disorder (AUD)DDT COA #000110: WHO Risk Drinking Levels of Alcohol ConsumptionWHO 2-level risk drinking reductionPatients diagnosed with an AUDPROLetter of Intent- Accepted
Musculoskeletal painDDT COA #000102: Physical Activity Accelerometry Assessment for Analgesic Clinical Trials (PAACT)Physical activityNon-cognitively impaired adults with a diagnosis of osteoarthritis of the kneeDHT- Passive Monitoring COALetter of Intent- Accepted
Opioid Use Disorder (OUD)DDT COA #000138: Opioid Craving PROChanges in opioid cravingPatients with mild to severe OUDPROLetter of Intent- Accepted
PainDDT COA #000073: QUALIfied for Therapeutic Evaluations of Pain (QUALITE-Pain)Pain intensityNon-cognitively impaired adults with acute and chronic painPROLetter of Intent- Accepted
Recovery from surgery and anesthesiaDDT COA #2019-01: PostopQRSRecovery processPatients undergoing all forms of surgery and anesthesiaPRO, PerfO, and ClinROLetter of Intent- Not Accepted

Office of Immunology and Inflammation (OII)
Division of Rheumatology and Transplant Medicine (DRTM)

Disease/ConditionDDT COA Number and Instrument NameConcept of InterestContext of UseCOA TypeQualification
Stage
Chronic Fatigue Syndrome (CFS)
Myalgic Encephalomyelitis (ME)
Systemic Exertion Intolerance Disease (SEID)
DDT COA #000080: PROMIS® Fatigue for ME/CFS/SEIDFatiguePatients with CFS, ME, or SEIDPROLetter of Intent- Accepted
Rheumatoid Arthritis (RA)DDT COA #000015: PROMIS® Short Form Fatigue 10a in Rheumatoid ArthritisFatigueAdult patients (>18 years) with a definite diagnosis of RA based on a score of ≥ 6 on the American College of Rheumatology/European League Against Rheumatism 2010 Rheumatoid Arthritis Classification CriteriaPROQualification Plan- Accepted 
Systemic Lupus Erythematosus (SLE)DDT COA #000135: Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) in Systemic Lupus Erythematosus (SLE)Presence and severity of signs of cutaneous manifestationsPatients with SLEClinROLetter of Intent-Accepted

Division of Pulmonary, Allergy, and Critical Care (DPACC)

Disease/ConditionDDT COA Number and Instrument NameConcept of InterestContext of UseCOA TypeQualification
Stage
AsthmaDDT COA #000099: Child Asthma Diary (CAD)Symptom severityChildren (4-11 years) with a clinical diagnosis of mild to severe persistent asthma requiring a daily long-term control medicationPRO/ObsROLetter of Intent- Accepted
Chronic Obstructive Pulmonary Disease (COPD)DDT COA #000072: Constant Work Rate ExerciseExercise endurance

COPD patients with moderate to very severe lung function impairment:

  • Patients diagnosed with COPD
  • Post-bronchodilator FEV1/FVC <70%
  • Post-bronchodilator FEV1 <80% predicted normal
  • Male or female patients, at least 40 years of age

Current or ex-smokers with a smoking history of more than 10 pack-years.

PerfOQualification Plan- Not Accepted
Chronic Obstructive Pulmonary Disease (COPD)DDT COA #000125: Endurance Shuttle Walking Test (ESWT)Walking enduranceCOPD patientsPerfOQualification Plan- Not Accepted
Idiopathic pulmonary fibrosis (IPF)DDT COA #000027: A Tool to Assess Quality of Life in Idiopathic Pulmonary Fibrosis (ATAQ-IPF)Symptom experience, daily functioning and other health-related quality of life impactsAdult patients (>18 years) with IPFPROLetter of Intent- Accepted

Division of Gastroenterology (DG)

Disease/ConditionDDT COA Number and Instrument NameConcept of InterestContext of UseCOA TypeQualification
Stage
Crohn’s disease (CD)DDT COA #000034: Crohn’s Disease Patient-Reported Outcomes Signs and Symptoms (CD-PRO/SS)Signs and symptoms of CDAdult patients (>18 years) with moderate to severe clinically active CD treated in the outpatient settingPROLetter of Intent- Accepted
Crohn’s disease (CD)DDT COA #000049: Pediatric Inflammatory Crohn’s MRE Index (PICMI)Disease activityChildren (5-17 years) with CDClinROLetter of Intent- Accepted
Crohn’s disease (CD)DDT COA #000076: TUMMY-CDSigns and symptoms of CDPediatric patients with CDPROLetter of Intent- Accepted
Crohn’s disease (CD)DDT COA #000092: PROMIS® Pediatric Crohn’s Disease Short Form - Fatigue 10Fatigue (frequency, duration and intensity)Children (8-17 years) with CDPROLetter of Intent- Accepted
Crohn’s Disease (CD)DDT COA #000093: PROMIS® Pediatric Crohn’s Disease Short Form – Pain InterferencePain interferenceChildren (8-17 years) with CDPROLetter of Intent- Not Accepted
Eosinophilic Esophagitis (EoE)DDT COA #000024: Pediatric Eosinophilic Esophagitis (EoE) Symptom Severity Module (PEESS™ v2.0)EoE SymptomsChildren (2-12 years) and adolescents (12-18 years) with EoEObsROLetter of Intent- Accepted
Functional dyspepsia (FD)DDT COA #000013: Functional Dyspepsia Symptom Diary (FDSD)FD symptom severityAdult patients that have met Rome III diagnostic criteria for FDPROLetter of Intent- Accepted
GastroparesisDDT COA #000020: The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD)Gastroparesis symptomsAdult patients (>18 years) with idiopathic or diabetic gastroparesisPROLetter of Intent- Accepted
Irritable Bowel SyndromeDDT COA #000148: Diary for Irritable Bowel Syndrome Symptoms- Diarrhea (DIBSS-D)Symptom SeverityAdults who meet Rome diagnostic criteria (Rome III or IV) and have active symptomsPROLetter of Intent- Accepted
Irritable Bowel SyndromeDDT COA #000151: Diary for Irritable Bowel Syndrome Symptoms- Mixed (DIBSS-M)Symptom SeverityAdults who meet Rome diagnostic criteria (Rome III or IV) for IBS-M and have active symptomsPROLetter of Intent- Accepted
Ulcerative colitis (UC)DDT COA #000040: Ulcerative Colitis Patient-Reported Outcomes Signs and Symptoms (UC-PRO/SS)Signs and symptoms of UCAdult patients (≥18 years of age) with moderate to severe UCPROIn legacy process*
Ulcerative colitis (UC)DDT COA #000041: TUMMY- UCUC signs and symptoms severityChildren and adolescents (2-18 years) with UCPRO/ObsROWithdrawn

Division of Hepatology and Nutrition (DHN)

Disease/ConditionDDT COA Number and Instrument NameConcept of InterestContext of UseCOA TypeQualification
Stage
Polycystic Liver Disease (PLD)DDT COA #000075: Polycystic Liver Disease Questionnaire (PLD-Q)PLD symptomsAdult patients with Gigot stage II or III PLDPROLetter of Intent- Accepted

Division of Dermatology and Dentistry (DDD)

Disease/ConditionDDT COA Number and Instrument NameConcept of InterestContext of UseCOA TypeQualification
Stage
Alopecia areata (AA)DDT COA #000101: Patient-Reported Symptoms and Impacts of Alopecia AreataConcepts related to hair loss and regrowth deemed important by patients with AAAdult patients (> 18 years) with AA with at least > 25% hair loss on scalp and current episode of hair loss lasting at least 6 monthsPROLetter of Intent- Accepted
Atopic dermatitisDDT COA #000120: Scratch SensorItch intensity and persistencePatients > 2 years with atopic dermatitisDHT- Passive Monitoring COALetter of Intent- Accepted
Cutaneous Lupus Erythematosus (CLE)DDT COA #000130: Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) in Cutaneous Lupus Erythematosus (CLE)Presence and severity of signs of CLEPatients with CLEClinROLetter of Intent- Accepted
Hidradenitis suppurativa (HS)DDT COA #000111: Hidradenitis Suppurativa Quality of Life (HiSQOL)Symptom severity, limitations in performance of activities, and psychosocial effectsAdult patients with HSPROLetter of Intent- Accepted
Hidradenitis suppurativa (HS)DDT COA #000118: Hidradenitis Suppurativa Area and Severity Index (HASI)Disease severity and extent of active (inflamed) HSAdult patients with HSClinROLetter of Intent- Accepted
ItchDDT COA #000116: PROMIS Itch Questionnaire – Children Impact (PIQ-C-Impact)Itch impacts on children’s daily livingPRO to be completed by children between ages 8-17 years

ObsRO to be completed by parents of children ages 5-17 years
PRO and ObsROLetter of Intent – Not Accepted
ItchDDT COA #000140: PROMIS Itch Questionnaire – Children Symptom (PIQ-C-Symptom)Itch symptoms in childrenPRO to be completed by children between ages 8-17 years

ObsRO to be completed by parents of children ages 5-17 years
PRO and ObsROLetter of Intent – Not Accepted

Office of Infectious Diseases (OID):
Division of Anti-Infectives (DAI)

Disease/ConditionDDT COA Number and Instrument NameConcept of InterestContext of UseCOA TypeQualification
Stage
Acute Bacterial Skin and Skin Structure InfectionDDT COA #000019: Skin Infection Patient-Reported Outcome Measure (SKINFECT-PRO)ABSSSI symptomsAdult patients (> 18 years) with ABSSSIPROLetter of Intent- Accepted
Acute otitis media (AOM)DDT COA #000083: Acute Otitis Media Severity of Symptoms Scale (AOM-SOS)AOM symptomsChildren with AOMObsROLetter of Intent- Accepted
Community-Acquired Bacterial Pneumonia (CABP)DDT COA #000018: Pneumonia Patient-Reported Outcome Measure (PNEUMO-PRO) for the measurement of CABP symptomsCABP symptoms Adult patients (> 18 years) with CABPPROLetter of Intent- Accepted
Cystic Fibrosis (CF)DDT COA #000007: The Cystic Fibrosis Respiratory Symptom Diary – Chronic Respiratory Infection Symptom Score (CFRSD-CRISS)CF symptom severityAdolescents (≥12 years) and adults with a chronic respiratory infection in stable patients and patients with an acute exacerbationPROIn legacy process*
Hospital-acquired Bacterial Pneumonia (HABP)DDT COA #000071: Pneumonia Patient-Reported Outcome Measure (PNEUMO-PRO) for the measurement of HABP symptomsHABP symptomsAdult patients (> 18 years) with HABPPROLetter of Intent- Accepted
Non-Cystic Fibrosis Bronchiectasis (NCFBE)DDT COA #000128: Symptom Assessment for Bronchiectasis (SABRE)Disease related symptomsAdult patients (>21 years) with NCFBE with or without non-tuberculous mycobacterial (NTM) infectionPROLetter of Intent- Accepted

*Under review prior to the passage of the 21st Century Cures Act

Office of Oncologic Diseases (OOD) 

Disease/ConditionDDT COA Number and Instrument NameConcept of InterestContext of UseCOA TypeQualification
Stage
CancerDDT COA #000079: PROMIS® Physical Function in OncologyPhysical functioningAdult patients (> 18 years) with solid tumors or hematologic malignancies with a performance status range 0-3 and receiving active anti-cancer therapyPROQualification Plan- Accepted
CancerDDT COA #000121: EORTC Quality of Life Core Questionnaire Physical Functioning (EORTC QLQ-C30)Physical functioningAdult patients (> 18 years) with cancer- all tumor types, locations, and stage of diseasePROLetter of Intent- Not Accepted

Division of Oncology 1 (DO1)

Disease/ConditionDDT COA Number and Instrument NameConcept of InterestContext of UseCOA TypeQualification
Stage
Plexiform neurofibroma (PN)DDT COA #000061: Plexiform Neurofibroma Impact in Children & AdultsTumor-related pain intensity, pain interference, and physical functioningChildren(>5 years) and adults with neurofibromatosis type 1 (NF1) and PNPROLetter of Intent- Accepted
Renal cell carcinoma (RCC)DDT COA #000117: Network/Function Assessment of Cancer Therapy- Disease Related Symptom Scale (NFKSI-DRS)Disease-related symptoms of RCCAdult patients (>18 years) with advanced or metastatic (AJCC stage IV) RCCPROLetter of Intent- Accepted

Division of Oncology 2 (DO2)

Disease/ConditionDDT COA Number and Instrument NameConcept of InterestContext of UseCOA TypeQualification
Stage
Small cell lung cancer (SCLC)DDT COA #000133: Small Cell Lung Cancer PROSCLC symptom severityAdult patients adults (>18 years) with clinician-confirmed diagnosis of limited or extensive stage SCLC with Eastern Cooperative Oncology Group performance status of 0 to 2, regardless of the lines of therapy being administeredPROLetter of Intent- Accepted

Office of Specialty Medicine (OSM):
Division of Ophthalmology (DO)

Disease/ConditionDDT COA Number and Instrument NameConcept of InterestContext of UseCOA TypeQualification Stage
Retinitis Pigmentosa (RP)DDT COA #000126: Functional Vision Questionnaire (FVQ) PROVisual function and functional visionAdolescents (12-17 years) and adults (>18 years) with a clinical and genetic confirmed diagnosis of RPPROLetter of Intent- Accepted
Retinitis Pigmentosa (RP)DDT COA #000127: Functional Vision Questionnaire (FVQ) ObsROVisual function and functional visionPediatric (3-11 years) patients with a clinical and genetic confirmed diagnosis of RPObsROLetter of Intent- Accepted

Resources

*Under review prior to the passage of the 21st Century Cures Act

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