Observational protocol

Clinica Terapeutica

Volumn 161, Issue 4, 2010, Pages 401-402

  Sacchini, D ^a   Pennacchini, M ^b  

^a CATHOLIC UNIVERSITY   (Italy)

^b UNIVERSITY CAMPUS BIO MEDICO   (Italy)

Author keywords

Clinical trial; Medical device; Observational protocol

Indexed keywords

CASE CONTROL STUDY; CLINICAL EVALUATION; COHORT ANALYSIS; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EXPOSURE VARIABLE; HUMAN; MEDICAL CARE; MEDICAL PRACTICE; OBSERVATIONAL METHOD; OBSERVATIONAL STUDY; RISK ASSESSMENT; SHORT SURVEY; SURGICAL TECHNIQUE;

OBSERVATION; RESEARCH DESIGN; TERMINOLOGY AS TOPIC;

EID: 77957222588     PISSN: 00099074     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Short Survey

References (8)

1. Council for International Organizations of Medical Sciences (CIOMS). Current Challenges in Pharmacovigilance: Pragmatic Approaches. Report of CIOMS Working Group V. Geneva, World Health Organization (WHO), 2001
2. European Medicines Agency (EMEA). Note for Guidance on Planning Pharmacovigilance Activities (ICH Topic E 2 E, Pharmacovigilance Planning (Pvp) - Step 5 (CPMP/ICH/5716/03)), 2005. http://www.emea.eu.int (access: 01/10/2008)
3. International Society for Pharmacoepidemiology (ISPE). Guidelines for Good Pharmacoepidemiology Practices (GPP). 2007. http://www.pharmacoepi.org/ resources/guidelines-08027.cfm (access: 01/10/08)
4. Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Epidemiological Studies. Geneva, World Health Organization (WHO), 2009
5. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use - ICH Harmonised Tripartite Guideline. Guideline For Good Clinical Practice, 1996. http://www.ich.org/LOB/ media/MEDIA482.pdf (access: 23/07/2010)
6. Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, 1997. http://conventions. coe.int/Treaty/EN/Treaties/Html/164.htm (access: 12/18/2007)
7. World Medical Association; 2004. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects, 2008. http://www.wma.net/e/policy/b3.htm (access: 23/07/2010)
8. World Health Organization; 2000. Operational Guidelines for Ethics Committees That Review Biomedical Research, TDR/PRD/ETHICS/2000.1. www.who.int/tdr/publications/publications/pdf/ethics.pdf (access: 01/10/08)