Links

Useful Links

A

• AMG: Act on the Marketing of Medicinal Products on the website of the Federal Ministry of Justice
• (Arbeitskreis medizinischer Ethik-Kommissonen) Working Group of Medical Ethics Committees in the Federal Republic of Germany

B

• BDSG: Federal Data Protection Act on the website of the Federal Ministry of Justice
• (Berufsordnung) Professional code of conduct for North Rhine physicians on the website of the North Rhine Medical Association
• BfArM: Federal Institute for Drugs and Medical Devices
• BfS: Federal Office for Radiation Protection
• Bioethics Convention: 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 ETS No.: 164 on the website of the Council of Europe

D

• Declaration of Helsinki (2013 version) in English of the World Medical Association
• DSG NRW: Law on the Protection of Personal Data (Data Protection Act of North Rhine-Westphalia) on the website of the Ministry of Justice of the State of North Rhine-Westphalia
• (DSGVO) GDPR: Regulation (EU) 2016/679 of the European Parliament and of the Council of April 27, 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation)

E

• EMEA: European Agency for the Evaluation of Medicinal Products
• (Empfehlungen zur Begutachtung) Recommendations on the evaluation of clinical trials by ethics committees: Documentation of the 29th Annual Meeting of the Working Group of Medical Ethics Committees in the Federal Republic of Germany on November 18, 2011, Cologne 2012
• EudraCT: European Clinical Trials Database
• EudraLex: The Rules Governing Medicinal Products in the European Union
• EU Directive 2001/20/EC of the European Parliament and of the Council of April 4, 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
• EU CommissionDirective 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use and the requirements for authorization of the manufacturing or importation of such products

G

• GCP-V: Regulation on the application of good clinical practice in the conduct of clinical trials with medicinal products for human use
• GDSG NW: Act on the Protection of Personal Data in the Healthcare Sector (Health Data Protection Act) on the website of the Ministry of Justice of the State of North Rhine-Westphalia
• GEP: Current version of the Good Epidemiological Practice

H

• HeilBerG: Heilberufsgesetz NRW on the website of the North Rhine Medical Association

I

• ICH-GCP Guideline: Note for Guidance on Good Clinical Practice [CPMP/ICH/135/95 - adopted July 96; PDF file, 248 KB] on the website of the EMEA (European Agency for the Evaluation of Medicinal Products)

L

• Guidelines and recommendations for safeguarding Good Epidemiological Practice (GEP) in the 2018 version

M

• MPG: Medical Devices Act on the website of the Federal Ministry of Justice

P

• PEI: Paul Ehrlich Institute

S

• Spirit statement: Standard protocol items: Reccomendations for interventional trials
• StrlSchG: Law for protection against the harmful effects of ionizing radiation