GCP inspections of clinical trials;GCP-Inspektionen von klinischen Prüfungen

Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz

Volumn 48, Issue 2, 2005, Pages 181-188

  Schwarz, G ^a  

^a Bundesinst Arzneimittel/Med Prod   (Germany)

Author keywords

Coordination; GCP inspections; Good Clinical Practice (GCP); Harmonisation; Inspection report

Indexed keywords

DRUG;

ARTICLE; CLINICAL STUDY; DECISION MAKING; DRUG RESEARCH; DRUG SURVEILLANCE PROGRAM; DRUG USE; GOOD CLINICAL PRACTICE; GOVERNMENT REGULATION; HUMAN; LEGAL ASPECT; MEDICAL DOCUMENTATION; PATIENT RIGHT; POLICY; QUALITY CONTROL; RELIABILITY; WELLBEING;

CLINICAL PROTOCOLS; CLINICAL TRIALS; DRUG APPROVAL; ETHICS, RESEARCH; EUROPE; EUROPEAN UNION; GERMANY; GUIDELINE ADHERENCE; HUMANS; INTERNATIONAL COOPERATION; QUALITY ASSURANCE, HEALTH CARE;

EID: 14844338551     PISSN: 14369990     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00103-004-0976-3     Document Type: Article

References (6)

1. World Medical Association, Declaration of Helsinki, Ethical Principles for Medical Research Involving Human Subjects, June 1964
2. CPMP Working Party on Efficacy of Medicinal Products, Good Clinical Practice for Trials on Medicinal Products in the European Community, June 1991
3. International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use - Consolidated Guideline Topic E 6, Guideline for Good Clinical Practice, July 1996
4. CPMP/ICH/135/97, Note for Guidance on Good Clinical Practice, July 1996
5. Richtlinie 2001/20/EG des europäischen Parlaments und des Rates vom 4. April 2001 zur Angleichung der Rechts- und Verwaltungsvorschriften der Mitgliedsstaaten über die Anwendung der guten klinischen Praxis bei der Durchführung von klinischen Prüfungen mit Humanarzneimitteln
6. Commission Directive "../.../EC laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of manufacturing or importation of such products"