ABPI Guidelines for Phase 1 Clinical Trials (PDF
ABPI Guidelines for Phase 1 Clinical Trials (PDF
ABPI Guidelines for Phase 1 Clinical Trials (PDF
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Essential documents - documents that are kept in the trial master file and enable the sponsor or MHRA to assess if a trial<br />
was carried out properly and to judge the quality of the data produced.<br />
European Agency <strong>for</strong> the Evaluation of Medicinal Products (EMEA) - coordinates the regulatory authorities, such as the<br />
MHRA, of all the EU countries.<br />
European Commission (EC) - an institution in Brussels that drafts proposals <strong>for</strong> EU legislation and does the day-to-day work<br />
of running the EU.<br />
European database of clinical trials (EudraCT) - a database in which all EU clinical trials must be registered.<br />
European Economic Area (EEA - the EU plus Iceland, Norway and Lichtenstein.<br />
European Union (EU) - a group of European countries with common policies.<br />
Exclusion criteria - reasons <strong>for</strong> excluding a subject from a trial, such as taking another medicine, having an illness or<br />
having out-of-range laboratory results.<br />
Expert Advisory Group of the Commission on Human Medicines - The Commission on Human Medicines advises the<br />
Government and the MHRA about medicinal products.<br />
Expert Advisory Groups - such as the one <strong>for</strong> higher-risk biological IMP - support the Commission.<br />
Expert Scientific Group (ESG) Report on <strong>Phase</strong> 1 <strong>Clinical</strong> <strong>Trials</strong> - report of an enquiry into the first-in-man trial of<br />
TGN1412.<br />
Faculty of Pharmaceutical Medicine - a section of the Royal College of Physicians that sets and maintains standards in<br />
pharmaceutical medicine through Higher Medical Training.<br />
Fc receptor - protein found on the surface of certain white blood cells that contribute to the protective function of the<br />
immune system.<br />
Finished product - an IMP that has undergone all stages of manufacture, including packaging and labelling in its final<br />
container.<br />
First-in-man clinical trial - a clinical trial in which a potential new medicine is given to humans <strong>for</strong> the very first time.<br />
General Medical Council (GMC) - registers and regulates UK physicians.<br />
Genes - a biological unit of heredity - a sequence of DNA that codes <strong>for</strong> one protein. The human genome has about<br />
70,000 genes.<br />
Gene therapy - the deliberate introduction of genetic material into human somatic cells <strong>for</strong> therapeutic, prophylactic or<br />
diagnostic purposes.<br />
Gene Therapy Advisory Committee (GTAC) - reviews proposals to conduct gene therapy research and advises about gene<br />
therapy.<br />
Genetic testing - to detect the presence or absence of, or variation in, a particular gene using a DNA, biochemical or other<br />
test. The metabolism of many medicines is affected by genetic differences in enzymes.<br />
Genetically modified micro-organisms (GMM) - micro-organisms that have had their genetic material altered by artificial<br />
means.<br />
Good clinical practice (GCP) - an international ethical and scientific quality standard <strong>for</strong> designing, conducting, recording,<br />
monitoring and reporting studies that involve human subjects. GCP ensures that the rights, safety and well-being of the<br />
trial subjects are protected, and that the trial data are credible and accurate.<br />
Good laboratory practice (GLP) - a set of principles <strong>for</strong> planning, per<strong>for</strong>ming, monitoring, reporting and archiving<br />
laboratory studies.<br />
Good manufacturing practice (GMP) - a set of principles which ensures that medicinal products are produced and<br />
controlled to the quality standards appropriate to their intended use.<br />
Governance Arrangements <strong>for</strong> NHS Research Ethics Committees (GAfREC) - guidelines issued by the National Research<br />
Ethics Service (NRES) that all REC must follow.<br />
Half-life - time <strong>for</strong> the concentration of an IMP or medicine to halve in the body.<br />
Health and Safety Executive (HSE) - responsible <strong>for</strong> en<strong>for</strong>cing regulations that ensure the health and safety of staff and<br />
visitors in the workplace.<br />
Hepatitis viruses B and C (HVB and HVC) - viruses that are transmitted by blood or blood products and cause liver<br />
disease.<br />
Higher Medical Training in pharmaceutical medicine - consists of seven advanced training modules in pharmaceutical<br />
medicine, of which clinical pharmacology is one, leading to the award of the Certificate of Completion of Specialist<br />
Training (CCST) by the Royal Colleges of Physicians.<br />
© Association of the British Pharmaceutical Industry 2007<br />
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