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

28cleclerical error syn. key-punch error; c.e. are mainly those of transferringinformation, e.g. person or instrument to document, documentto punch cards or computers, computer output to reports,typing mistakes a.s.o.; → see also bias.clinical development plan Plan for clinical development of a newdrug, from first application in man to drug registration; such a planusually includes e.g.: overview of the therapeutic indication(s),target product profile, profile of competitive drugs, properties ofthe new substance, justification for development, overview ofprinciple clinical trials with design and size, drug supplies, staffingrequirements and financial resources; → see study list.clinical hold FDA: “A c.h. is an order issued by FDA to the sponsorto delay a proposed clinical investigation or to suspend an ongoinginvestigation.”clinical investigation → see clinical trial.clinical program outline → see study list.clinical research assistant (CRA) → see clinical research associate.clinical research associate (CRA) syn. clinical research assistant;person performing mainly the “on-site” monitoring activity of atrial; also called “home based CRA” or local CRA if based outsideof the office of a company; some of these activities may be also delegatedto a “study nurse”; → see also monitor.clinical research coordinator (CRC) → see clinical trial coordinator,Study Coordinator.clinical research executive (CRE) Member of the clinical researchstaff, e.g. a monitor.clinical research manager (CRM) syn. clinical trial manager; responsibleperson for a clinical project, including the supervision ofmonitoring; nominated by the sponsor; → see also clinical trialcoordinator.clinical research organisation (CRO) → see contract researchorganisation.clinical significance → see delta value.clinical study → see clinical trial.clinical trial (CT) syn. clinical investigation, clinical study; “any systematicand carefully designed study on medicinal products inhuman subjects whether in patients or non-patient volunteers”;the aim of a CT is to discover or verify the effects of, and identifyany adverse reaction to (investigational) products and to studytheir absorption, distribution, metabolism and excretion in orderto ascertain the efficacy and safety of the product; a CT can beeither prospective (nonrandomized observational cohort, randomizedcontrolled – frequently double-blind –, withdrawal,