Validation of a risk-assessment scale and a risk-adapted monitoring plan for academic clinical research studies - The Pre-Optimon study

Contemporary Clinical Trials

Volumn 32, Issue 1, 2011, Pages 16-24

  Journot, Valérie ^a,b   Pignon, Jean Pierre ^c   Gaultier, Claude ^a   Daurat, Véronique ^d   Bouxin Métro, Annie ^e   Giraudeau, Bruno ^a   Preux, Pierre Marie ^f   Tréluyer, Jean Marc ^g   Chevret, Sylvie ^h   Plättner, Valérie ⁱ   Thalamas, Claire ^a   Clisant, Stéphanie ^j   Ravaud, Philippe ^k   Chêne, Geneviève ^a,b,l  

^a INSERM   (France)

^b Centre of Clinical Investigation Clinical Epidemiology   (France)

^c INSTITUT GUSTAVE ROUSSY   (France)

^d ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS   (France)

^e ANRS   (France)

^f LIMOGES UNIVERSITY HOSPITAL   (France)

^g HÔPITAL NECKER ENFANTS MALADES   (France)

^h SAINT LOUIS HOSPITAL   (France)

ⁱ HOSPICES CIVILS DE LYON   (France)

^j CENTRE OSCAR LAMBRET   (France)

^k HÔTEL DIEU   (France)

^l BORDEAUX UNIVERSITY HOSPITAL   (France)

more..

Author keywords

Clinical trial; Intraclass correlation coefficient; Kappa coefficient; Monitoring plan; Proportional odds model; Risk assessment scale; Risk based approach

Indexed keywords

ADULT; ARTICLE; CLINICAL ASSESSMENT TOOL; CLINICAL DECISION MAKING; CLINICAL RESEARCH; CONSENSUS; CONTROLLED STUDY; CORRELATION COEFFICIENT; EVALUATION; FEASIBILITY STUDY; FEMALE; GOOD CLINICAL PRACTICE; HUMAN; INFORMATION RETRIEVAL; LOGISTIC REGRESSION ANALYSIS; MANAGER; MEDICAL LITERATURE; PROFESSIONAL COMPETENCE; REPRODUCIBILITY; RISK ADAPTED MONITORING PLAN; RISK ASSESSMENT; RISK ASSESSMENT SCALE; STANDARD; VALIDATION STUDY; VISUAL ANALOG SCALE;

CLINICAL PROTOCOLS; HUMANS; OBSERVER VARIATION; PRACTICE GUIDELINES AS TOPIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REPRODUCIBILITY OF RESULTS; RISK ASSESSMENT; STATISTICS, NONPARAMETRIC;

EID: 78649906288     PISSN: 15517144     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cct.2010.10.001     Document Type: Article

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