Risk analysis and risk adapted on-site monitoring in noncommercial clinical trials

Clinical Trials

Volumn 6, Issue 6, 2009, Pages 585-596

  Brosteanu, Oana ^a   Houben, Peggy ^a   Ihrig, Kristina ^b   Ohmann, Christian ^c   Paulus, Ursula ^d   Pfistner, Beate ^d,e   Schwarz, Gabriele ^f   Strenge Hesse, Anke ^g   Zettelmeyer, Ulrike ^d  

^a UNIVERSITY OF LEIPZIG   (Germany)

^b GOETHE UNIVERSITY   (Germany)

^c HEINRICH HEINE UNIVERSITY   (Germany)

^d UNIVERSITY OF COLOGNE   (Germany)

^e UNIVERSITY OF BONN   (Germany)

^f FEDERAL INSTITUTE FOR DRUGS AND MEDICAL DEVICES   (Germany)

^g UNIVERSITY OF COLOGNE   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL PROTOCOL; CLINICAL STUDY; GOOD CLINICAL PRACTICE; HUMAN; MEDICAL AUDIT; PATIENT RIGHT; PATIENT SAFETY; PATIENT SELECTION; PRIORITY JOURNAL; QUESTIONNAIRE; RISK ASSESSMENT; TOTAL QUALITY MANAGEMENT;

CLINICAL PROTOCOLS; CLINICAL TRIALS AS TOPIC; CLINICAL TRIALS DATA MONITORING COMMITTEES; DATA INTERPRETATION, STATISTICAL; DECISION MAKING; HUMANS; QUALITY CONTROL; REMINDER SYSTEMS; RESEARCH DESIGN; RISK ASSESSMENT; SAFETY MANAGEMENT;

EID: 77149136737     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774509347398     Document Type: Article

References (12)

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