Good clinical practice
From Wikipedia, the free encyclopedia
Good clinical practice is a set of rules and regulations that is provided by International Conference on Harmonisation (ICH) - an international body that regulates clinical trials involving human subjects.
Good clinical practice guidelines include protection of human rights as a subject in clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds.
Good clinical Practice Guidelines includes regulations on how clinical trials should be conducted, define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and Clinical research associates.
[edit] ICH GCP overview
- Guidelines for the investigator
- Guidelines for the trial sponsor (industrial, academic)
- Guidelines for the clinical trial protocol and protocol amendments
- Guidelines for the Investigator's brochure
[edit] See also
- GxP
- Clinical site
- Drug development
- Institutional Review Board
- Data Monitoring Committees
- Food and Drug Administration (FDA)
- Directive 2001/20/EC (European Union)
- European Medicines Agency (EMEA)
- Japan Ministry of Health
- Pharmacovigilance
- EudraVigilance
- European Forum for Good Clinical Practice (EFGCP)
- Pharmaceutical company
[edit] External links
- Food and Drug Administration (FDA)
- Good Clinical Practices (from U.S. FDA website)
- Nuremberg Code - ethical code
- Handbook for Managers in Medical Writing/Communication:http://www.amazon.de/gp/product/3828890830/302-8825038-2472032?v=glance&n=299956
- Declaration of Geneva - ethical code
- Clinical Research Abbreviations and Acronyms (commercial site)
- List of Food and Drug Regulatory Agencies (commercial site)
- Association of Clinical Research Professionals (Russia, Ukraine)
- Good Clinical Practices (from quality medical regulators services)de:Good Clinical Practice
