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

159duties on the Community citizen in the same way as national law;the Member States and their governing institutions and courts arebound directly by community law and have to comply with in thesame way as with national law (“direct applicability”); in contrastto guidelines, r. are legally enforceable; → see ec law.reimbursement → see Black list, copayment, cost/effectiveness,defined daily dose, anatomical therapeutic chemicalclassification system, negative list, positive list, quality oflife.relational data base Special, structured d.b. whereby data are managedand stored with an a priori logical relationship between thedata; → see also data manager.relative bioavailability → see bioavailability.relative risk → see risk.release certificate Certificate documenting that adequate qualitycontrols have been performed and that the investigational medicinalproduct has been released by a qualified individual priorto being used in clinical trials; r.c. must be available in the trialmaster file.reliability Usually determined by the extent that a score has repeatabilitybetween identical or equivalent tests, therefore by: interpersonr. = consistency of scoring between different individuals,test re-test r. = consistency of scoring over a short period of timewhen subjects have not changed, and internal r. = correlation ofindividual items to the total score; → see also measurement properties,validity.remote data entry Capturing data at site where they are generated,e.g. at the investigational centre; the electronic data can than beeither stored locally and transferred later or can be transferred online;→ see also computerised systems, data entry, electronicdata capture, remote data entry, source data, Web-baseddata entry.renewal Marketing Authorisations (MA) granted in the EuropeanCommunity have an initial duration of 5 years; at least 6 monthsbefore the authorization ceases the MA holder must provide thecompetent authority with a consolidated version of the file in respectof quality, safety and efficacy in order to maintain MA; oncerenewed the MA shall be valid for an unlimited period; → see alsomarketing authorisation, sunset clause.repeatability Level of agreement between replicate measurementsmade in the same subject; → see also measurement properties.repeated dose toxicity → see toxicity.repeated looks on data → see interim-analysis, multiple comparisons.rep