Decree on the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use;Verordnung über die Anwendung der guten klinischen Praxis bei der Durchführung von klinischen Prüfungen mit Arzneimitteln zur Anwendung an Menschen (GCP-Verordnung)

Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz

Volumn 48, Issue 2, 2005, Pages 147-154

  Schwerdtfeger, Walter K ^a  

^a Bundesmin Gesundheit/Soz Sicherung   (Germany)

Author keywords

Clinical trials; Ethics committee; EudraCT database; EudraVigilance database; Good clinical practice

Indexed keywords

DRUG;

ARTICLE; DRUG LABELING; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG RESEARCH; DRUG SURVEILLANCE PROGRAM; DRUG USE; GERMANY; GOOD CLINICAL PRACTICE; GOOD MANUFACTURING PRACTICE; HUMAN; MEDICAL DOCUMENTATION; PATIENT RIGHT; POLICY; RESEARCH ETHICS;

ADVERSE DRUG REACTION REPORTING SYSTEMS; CLINICAL TRIALS; ETHICS COMMITTEES; EUROPE; EUROPEAN UNION; GERMANY; GUIDELINE ADHERENCE; HUMANS; INFORMED CONSENT; INTERNATIONAL COOPERATION; PATIENT SELECTION; QUALITY ASSURANCE, HEALTH CARE;

EID: 14844365206     PISSN: 14369990     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00103-004-0979-0     Document Type: Article

References (10)

1. ABI. EG Nr. L 121, S. 34
2. (Entwurf) Commission directive 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 or importation of such products (über: http://pharmacos.eudra.org/F2/pharmacos/new.htm)
3. BGBI. I Nr. 41, S. 2031ff
4. BR-Drs. 115/1/04, S. 19
5. BT-Drs. 15/2849, S. 4
6. BT-Drs. 15/2849, S. 65
7. BGBI I Nr. 42, S. 2081 ff.
8. ABI. EG Nr. L 311, S. 67
9. ABI. EG Nr. L 262, S. 22
10. EudraLex, Medicinal products for human and veterinary use, Vol. 4, Good manufacturing practice, Annex 13: Manufacture of investigational medicinal products, Revision 1 (über: http://pharmacos.eudra.org/F2/ eudralex/vol-4/home.htm; keine Papierversion und keine deutsche Sprachversion verfügbar)