Administrative complexities for a European observational study despite directives harmonising requirements

Pharmacoepidemiology and Drug Safety

Volumn 21, Issue 8, 2012, Pages 851-856

  Gülmez, Sinem Ezgi ^a   Lignot Maleyran, Séverine ^a   de Vries, Corinne S ^b   Sturkenboom, Miriam ^c   Micon, Sophie ^a   Hamoud, Fatima ^a   Blin, Patrick ^a   Moore, Nicholas ^a  

^a UNIVERSITÉ DE BORDEAUX   (France)

^b University of Bath   (United Kingdom)

^c ERASMUS UNIVERSITY ROTTERDAM   (Netherlands)

Author keywords

Data protection; European Directive; Observational study; Pharmacoepidemiology; Regulations

Indexed keywords

ARTICLE; CASE STUDY; COMPUTER SECURITY; DIRECTIVE COUNSELING; EUROPE; FRANCE; GREECE; HOSPITAL; HUMAN; INFORMATION PROCESSING; INSTITUTIONAL REVIEW; IRELAND; ITALY; LIVING WILL; MEDICAL RECORD REVIEW; MULTICENTER STUDY (TOPIC); NETHERLANDS; OBSERVATIONAL STUDY; PHARMACOEPIDEMIOLOGY; POPULATION RESEARCH; PORTUGAL; PRIORITY JOURNAL; PROFESSIONAL STANDARD; UNITED KINGDOM;

ETHICS COMMITTEES, RESEARCH; EUROPEAN UNION; HUMANS; INTERNATIONAL COOPERATION; LIVER TRANSPLANTATION; RETROSPECTIVE STUDIES; TISSUE AND ORGAN PROCUREMENT;

EID: 84864371680     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3204     Document Type: Article

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