Design considerations in an active medical product safety monitoring system

Pharmacoepidemiology and Drug Safety

Volumn 21, Issue SUPPL. 1, 2012, Pages 32-40

  Gagne, Joshua J ^a   Fireman, Bruce ^b   Ryan, Patrick B ^c   Maclure, Malcolm ^d,e   Gerhard, Tobias ^f   Toh, Sengwee ^g   Rassen, Jeremy A ^a   Nelson, Jennifer C ^h,i   Schneeweiss, Sebastian ^a  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b DIVISION OF RESEARCH   (United States)

^c JOHNSON AND JOHNSON   (United States)

^d UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^e MINISTRY OF HEALTH   (Canada)

^f RUTGERS UNIVERSITY   (United States)

^g HARVARD MEDICAL SCHOOL   (United States)

^h GROUP HEALTH RESEARCH INSTITUTE   (United States)

ⁱ UNIVERSITY OF WASHINGTON   (United States)

Author keywords

Exposure characteristics; Outcome characteristics; Pharmacoepidemiology; Safety monitoring; Study design

Indexed keywords

ARTICLE; CLASSIFICATION; COHORT ANALYSIS; CONFOUNDING VARIABLE; CONSUMER; DATA BASE; DECISION MAKING; DRUG EXPOSURE; DRUG MONITORING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG USE; ELECTRONIC MEDICAL RECORD; ERROR; INTERMETHOD COMPARISON; MEASUREMENT; OBSERVER BIAS; PATIENT COMPLIANCE; PRIORITY JOURNAL; PROCESS DESIGN; PROSPECTIVE STUDY; SAMPLING; STANDARD;

BIAS (EPIDEMIOLOGY); CONFOUNDING FACTORS (EPIDEMIOLOGY); DATABASES, FACTUAL; DECISION MAKING; ELECTRONIC HEALTH RECORDS; EPIDEMIOLOGIC RESEARCH DESIGN; EQUIPMENT AND SUPPLIES; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); PHARMACEUTICAL PREPARATIONS; PRODUCT SURVEILLANCE, POSTMARKETING; PROGRAM DEVELOPMENT;

EID: 84856050291     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.2316     Document Type: Article

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