470 related articles for article (PubMed ID: 19221985)
1. [Clinical trials with minors in Germany--effects of the 12th amendment to the German Drug Code on the numbers of applications to Institutional Review Boards (IRB)].
Kölch M; Märsch C; Fegert JM; Lippert HD
Gesundheitswesen; 2009 Mar; 71(3):127-33. PubMed ID: 19221985
[TBL] [Abstract][Full Text] [Related]
2. [Effects of the 12th amendment to the German drug code on investigator-initiated clinical trials].
Kehrel U
Gesundheitswesen; 2011 Oct; 73(10):696-701. PubMed ID: 20859850
[TBL] [Abstract][Full Text] [Related]
3. [The 12th German Drug Law (AMG) amendment: an obstruction for non-commercial clinical trials?].
Schwarz S; Frölich L; Striebel JP; Hennerici MG
Dtsch Med Wochenschr; 2007 Jan; 132(3):108-12. PubMed ID: 17219346
[No Abstract] [Full Text] [Related]
4. [The 12th amendment to the German Drug Law. Chances and obstacles for investigator-initiated clinical trials].
Dreier G; Marx C; Schmoor C; Maier-Lenz H
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2005 Apr; 48(4):445-52. PubMed ID: 15830256
[TBL] [Abstract][Full Text] [Related]
5. [Responsibilities of ethics committees].
von Bergmann K
Med Klin (Munich); 2000 May; 95(1 Spec No):15-7. PubMed ID: 10851843
[TBL] [Abstract][Full Text] [Related]
6. [Differences between clinical trials according to the German law on pharmaceuticals (Arzneimittelgesetz) and trials according to the German law on medical products (Medizinproduktegesetz)].
Krummenauer F
Ophthalmologe; 2003 Feb; 100(2):150-4. PubMed ID: 12589461
[TBL] [Abstract][Full Text] [Related]
7. [The effects of the 12th and 14th amendments to the AMG (Medical Preparations Act) on paediatric pharmaceutical research--a survey of the new regulations].
Kölch M; Lippert HD; Fegert JM
Z Kinder Jugendpsychiatr Psychother; 2006 Mar; 34(2):117-26. PubMed ID: 16610597
[TBL] [Abstract][Full Text] [Related]
8. Stem cell transplantation in children: how to design a new study.
Corbacioglu S;
Bone Marrow Transplant; 2008 Jun; 41 Suppl 2():S30-4. PubMed ID: 18545241
[TBL] [Abstract][Full Text] [Related]
9. [Ethical principles for clinical studies with minors. Medical progress only for adults?].
Koch HJ; Raschka C
MMW Fortschr Med; 2002 Sep; 144(38):51. PubMed ID: 12395705
[No Abstract] [Full Text] [Related]
10. [Clinical research in Germany at the example of oncology].
Seufferlein T; Adler G
Onkologie; 2010; 33 Suppl 7():1-5. PubMed ID: 20926906
[TBL] [Abstract][Full Text] [Related]
11. Clinical research projects at a German medical faculty: follow-up from ethical approval to publication and citation by others.
Blümle A; Antes G; Schumacher M; Just H; von Elm E
J Med Ethics; 2008 Sep; 34(9):e20. PubMed ID: 18757621
[TBL] [Abstract][Full Text] [Related]
12. [Evaluation of clinical trials following an approval from a research ethics committee].
Menzel S; Uebing B; Hucklenbroich P; Schober O
Dtsch Med Wochenschr; 2007 Nov; 132(44):2313-7. PubMed ID: 17957593
[TBL] [Abstract][Full Text] [Related]
13. [Clinical research with pharmaceutical agents in Germany: effects of the 12th amendment to the German Drug Law].
Götte D; Weihrauch TR
Internist (Berl); 2004 Jun; 45 Suppl 1():S48-54. PubMed ID: 15138642
[TBL] [Abstract][Full Text] [Related]
14. Variation in standards of research compensation and child assent practices: a comparison of 69 institutional review board-approved informed permission and assent forms for 3 multicenter pediatric clinical trials.
Kimberly MB; Hoehn KS; Feudtner C; Nelson RM; Schreiner M
Pediatrics; 2006 May; 117(5):1706-11. PubMed ID: 16651328
[TBL] [Abstract][Full Text] [Related]
15. Case study: institutional review board (IRB) did not know about subject problem until after study.
Maloney DM
Hum Res Rep; 2006 May; 21(5):6-7. PubMed ID: 16832916
[No Abstract] [Full Text] [Related]
16. Variation in institutional review board responses to a standard, observational, pediatric research protocol.
Mansbach J; Acholonu U; Clark S; Camargo CA
Acad Emerg Med; 2007 Apr; 14(4):377-80. PubMed ID: 17312334
[TBL] [Abstract][Full Text] [Related]
17. [Therapeutic trial, clinical research and therapeutic freedom--legal boundaries].
Deutsch E
Z Arztl Fortbild Qualitatssich; 1997 Nov; 91(7):698-700; discussion 701. PubMed ID: 9527472
[TBL] [Abstract][Full Text] [Related]
18. [Harmonisation of regulatory requirements for clinical trials on medicinal products for human use in the Directive 2001/20/EC and complementary guidance. Implementation of the 12th Law Amending the German Drug Law].
Geisler I; Hofmann HP; Nickel L
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2005 Feb; 48(2):141-6. PubMed ID: 15726454
[TBL] [Abstract][Full Text] [Related]
19. [Reorganization of the procedures and the tasks of the responsible ethics committees after the 12th AMG amendment. Concepts of the permanent working group of the medical ethics committees in Germany].
Wessler I; Burger R; Doppelfeld E
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2005 Feb; 48(2):155-67. PubMed ID: 15726456
[TBL] [Abstract][Full Text] [Related]
20. Case study: agency says institutional review board (IRB) did not fulfill duties so agency investigation expands.
Maloney DM
Hum Res Rep; 2006 Apr; 21(4):6-7. PubMed ID: 16832919
[No Abstract] [Full Text] [Related]
[Next] [New Search]