Insurance and clinical trials

Contemporary Clinical Trials

Volumn 33, Issue 4, 2012, Pages 573-

  Minacori, Roberta ^a   Sacchini, Dario ^a   Cicerone, Marina ^a   Spagnolo, Antonio G ^a  

^a CATHOLIC UNIVERSITY   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

RADIOPHARMACEUTICAL AGENT;

CELL THERAPY; CLINICAL TRIAL (TOPIC); DRUG EFFICACY; DRUG SAFETY; EUROPEAN UNION; GENE THERAPY; HEALTH INSURANCE; HUMAN; LETTER; MARKETING; MEDICOLEGAL ASPECT; OFF LABEL DRUG USE; PATIENT SAFETY; PRACTICE GUIDELINE; RESEARCH SUBJECT; RISK ASSESSMENT;

CLINICAL TRIALS AS TOPIC; ETHICS COMMITTEES, RESEARCH; GOVERNMENT REGULATION; INSURANCE; ITALY;

EID: 84861529089     PISSN: 15517144     EISSN: 15592030     Source Type: Journal    
DOI: 10.1016/j.cct.2012.02.015     Document Type: Letter

References (3)

1. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official Journal of the European Communities, 1.05.2001. Available at: (Accessed July 15 2011). http://www.eortc.be/Services/Doc/clinical-EU-directive-04-April-01.pdf.
2. Ministerial Decree 14 July 2009, Minimum requirements for insurance policies which safeguard participants to clinical trials of medicinal products, Gazzetta Ufficiale della Repubblica Italiana, Serie generale 213, 14.9.2009. Available at: (Accessed July 15 2011). http://ricerca-clinica.agenziafarmaco.it/sites/default/files/files_wysiwyg/files/Normativa/MD_14_July_2009_English.pdf.
3. European Commission - Health and Consumers Directorate-General. Revision of the 'Clinical Trial Directive' 2001/20/EC. Concept Paper submitted for public consultation. p. 12. Available at: (Accessed July 15, 2011). http://ec.europa.eu/health/files/clinicaltrials/concept_paper_02-2011.pdf.