Best Practice Recommendations for Electronic Patient-Reported Outcome Dataset Structure and Standardization to Support Drug Development

Author:

Hudgens Stacie,Kern Scottie,Barsdorf Alexandra I.,Cassells Sally,Rowe Alison,King-Kallimanis Bellinda L.,Coon Cheryl,Low Geoff,Eremenco Sonya

Funder

U.S. Department of Health and Human Services

U.S. Food and Drug Administration

Publisher

Elsevier BV

Subject

Public Health, Environmental and Occupational Health,Health Policy

Reference6 articles.

1. Equivalence of electronic and paper-based patient-reported outcome measures;Campbell;Qual Life Res,2015

2. Current applications and future directions for the CDISC Operational Data Model standard: a methodological review;Hume;J Biomed Inform,2016

3. Comparability of a provisioned device versus bring your own device for completion of patient-reported outcome measures by participants with chronic obstructive pulmonary disease: quantitative study findings;Hudgens;J Patient Rep Outcomes,2022

4. National Medical Products Administration. Center for Drug Evaluation. https://www.nmpa.gov.cn/directory/web/nmpa/images/obbSqc7vwdm0ssrU0enKb7dtd29u9a4tbzUrdTyo6jK1NDQo6mhty5wZGY=.pdf. Accessed December 22, 2021.

5. Information about the raw data proof-of-concept pilot for industry. European Medicines Agency. https://www.ema.europa.eu/en/documents/other/information-about-raw-data-proof-concept-pilot-industry_en.pdf. Accessed December 22, 2021.

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