220-Dictionary of Pharmaceutical Medicine, 2nd Edition-Gerhard Nahler Annette Mollet-3211898352-S

29rechallenge, etc.) or retrospective (historical control, casecontrolstudy, cross-sectional study); activities concerningCTs are usually divided into 4 stages: a planning or set-up phase,requiring about a few weeks to several months for protocol andcase record form preparation, packaging, labelling and regulatoryreview incl. by an ethical committee, a patient treatment ormonitoring phase (including follow-up) and finally the analysisas well as the reporting phase, requiring also a few weeks to severalmonths for data clean-up, quality assurance, statistical analysisand report writing; → see also design, medical office trial,megatrial, multicentre trial, non-alpha site, postmarketingsurveillance, run-in phase.clinical trial authorisation (CTA) Formal approval to do studies; insome countries formal approval by health authorities to do studiesesp. with experimental drugs is requested (at least for geneticallymodified organisms or the very first application of a new drug inman), e.g. US, UK, France, most countries in Eastern Europe a.s.o.;other countries have less strict regulations and only notificationto the health authority is necessary, e.g. Australia, Germany a.s.o.;→ see also clinical trial certificate, clinical trial exemption.clinical trial certificate (CTC) Formal approval to do studies in theUK; valid for 2 years, renewable; → see also clinical trial authorisation,clinical trial exemption.clinical trial compensation guidelines Guidelines produced by theABPI; according to which compensation should be paid when theinjury was attributable to the medicinal product or any procedureprovided for by the protocol, for the more serious injury of an enduringand disabling character (not for temporary pain or discomfort),for injuries caused by procedures adopted to deal with adversereactions to a product under trial, regardless of whether thereaction was foreseeable or predictable or whether the patient isable to prove negligence of the company; → see also insurance.clinical trial coordinator (CTC) syn. clinical coordinator, trial c.,study c., research c.; in large and complex trials it may be suitableto nominate a person acting as liaison between sponsor and investigatorand for administrative responsibilities, e.g. who coordinatesdates for visits, investigations a.s.o. but reviews also dataand records before monitor’s visit; → see also clinical researchmanager, study coordinator, study nurse.clinical trial data base (CTDB) Public data base that lists planned orongoing clinical trials; editors of biomedical journals request that aclinical trial has been listed in a CTDB in order to be considered forpublication (International Committee of Medical Journal Editors:Uniform requirements for manuscripts submitted to biomedicalcli