Clinical protocol; Clinical trial directive; Ethics committees; GCP; Good manufacturing practice; ICH GCP; Inspections; Laboratories; Quality assurance; Research governance framework; Resuscitation Council; Validated computers; Volunteers
Indexed keywords
CLINICAL PHARMACOLOGY;
CLINICAL PRACTICE;
CLINICAL PROTOCOL;
CLINICAL TRIAL;
COMPUTER;
ETHICS;
HUMAN;
PRACTICE GUIDELINE;
PRIORITY JOURNAL;
PUBLIC HEALTH SERVICE;
QUALITY CONTROL;
REVIEW;
UNITED KINGDOM;
CLINICAL PROTOCOLS;
CLINICAL TRIALS;
DRUG INDUSTRY;
HUMANS;
INFORMED CONSENT;
MEDICAL RECORDS;
PHARMACOLOGY, CLINICAL;
PROFESSIONAL PRACTICE;
QUALITY ASSURANCE, HEALTH CARE;
Directive 2001/20/EC of the European parliament and of the council of 04 April 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
European Parliament. Directive 2001/20/EC of the European parliament and of the council of 04 April 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. Official Journal of the European Communities 2001; 121: 34-44.
World Medical Association (WMA). Declaration of Helsinki, 52nd WMA General Assembly. Edinburgh, Scotland, 2000. Available at: http://www.wma.net/e/policy/17-c_e.html
International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH)
London: European Agency for the Evaluation of Medicinal Products
International. Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH). Topic E6 Note for Guidance on Good Clinical Practice: Consolidated Guideline. London: European Agency for the Evaluation of Medicinal Products, 1996.
International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH)
International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH). ICH Topics and Guidelines. Available at: http://www.ifpma.org/ich5.htm
International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH)
London: European Agency for the Evaluation of Medicinal Products
International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH). Topic M4 Organisation of Common Technical Document for the Registration of Pharmaceuticals for Human Use CPMP/ICH/2887/99. London: European Agency for the Evaluation of Medicinal Products, 2000.
Food Drug Administration (FDA). Protection of Human Subjects Code of Federal Regulations, Title 21, Part 50-56. Washington: US Government Printing Office, 1997
Food Drug Administration (FDA). Protection of Human Subjects Code of Federal Regulations, Title 21, Part 50-56. Washington: US Government Printing Office, 1997.
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International conference on harmonization, good clinical practice: Consolidated guidelines
Food Drug Administration (FDA). International conference on harmonization, good clinical practice: consolidated guidelines. Federal Register 1997; 62: 25692-25709.
Food and Drug Administration (FDA). Guidance for Industry - Computerized Systems Used in Clinical Trials. Rockville,USA: Division of Compliance Policy, 1999.
Brussels, Belgium: Directorate-General Office, new draft 2001
European Commission. Revision of Annex 13 to the European Guide to Good Manufacturing Practice. Brussels, Belgium: Directorate-General Office, 1996, (new draft 2001).
EU Directive on good clinical practice in clinical trials
Department of Health (UK) and Medicines Control Agency (UK). EU Directive on good clinical practice in clinical trials. In DH and MCA Briefing Note. Available at: http://www.mca.gov.uk