Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium Guidance

The Patient-Reported Outcomes Safety Event Reporting (PROSPER) Consortium was convened to improve safety reporting by better incorporating the perspective of the patient. PROSPER comprises industry, regulatory authority, academic, private sector and patient representatives who are interested in the...

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Bibliographic Details
Published in:	Drug safety Vol. 36; no. 12; pp. 1129 - 1149
Main Authors:	Banerjee, Anjan K., Okun, Sally, Edwards, I. Ralph, Wicks, Paul, Smith, Meredith Y., Mayall, Stephen J., Flamion, Bruno, Cleeland, Charles, Basch, Ethan
Format:	Journal Article
Language:	English
Published:	Cham Springer International Publishing 01.12.2013 Adis International Springer Nature B.V
Subjects:	Adverse Drug Reaction Reporting Systems Biological and medical sciences Clinical trial. Drug monitoring Clinical trials Data Collection Data Mining - methods Drug Safety and Pharmacovigilance Employment General pharmacology Humans Leading Leading Article Medical sciences Medicine Medicine & Public Health Outcome Assessment (Health Care) Pharmaceutical industry Pharmacology. Drug treatments Pharmacology/Toxicology Point-of-Care Systems Reporting requirements Risk Assessment Social networks Web sites USA Adverse Event Data Medicinal Product Safety Monitoring System Uppsala Monitoring Centre Untoward Medical Occurrence Human Prognosis Treatment Toxicity Consortium Complication Clinical trial Pharmacovigilance Recommendation
ISSN:	0114-5916, 1179-1942, 1179-1942
Online Access:	Get full text
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