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

11exposed to the risk factor (more correct: a proportion, not a rate; refersusually to infectious diseases); → see also incidence, outcomemeasurement, prevalence rate, secondary attack rate.attributable risk → see risk.audit Inspection of facilities, documentation and procedures of clinicalinvestigator, sponsor, contract research organisation,ethics committee etc; audits are made to ensure that either theinternal system or a trial is performed in accordance with goodclinical practice (GCP)/GXP and national law, including ethicalconsiderations as well as that raw data and associated recordshave been accurately reported, and to establish whether practiceswere employed in the development of data that would impair theirvalidity; audits are part of a quality assurance system; audits orinspections usually start with an opening meeting and end with aclosing meeting (→ see exit interview); types of a.: official externala. = inspection by a supervisory authority, unofficial external a. =visit by a service company contract service organisation, CROon request by the sponsor, unofficial internal a. = carried out byan internal structure (e.g. quality assurance department, parentcompany) EC (III): “An internal a. independent of those participatingin the trial should be conducted by or on behalf of the sponsorto assure the integrity of the quality control system”; “the sponsoris responsible for conducting an internal a. of the trial” and forassuring “the investigators’ acceptance of verification procedures,audit, and inspection”; a. are performed either as “during-study” a.or as “post-study” a.; usually the written final “Evaluation Report”reveals only findings e.g. deficiencies; an a. is not a scientific evaluationof the data of a study; a trial audit is a comparison of raw dataand associated records with the interim or final report; a regulatorya. is the verification of the credibility of data and the evaluationof the design, planning, conduct, monitoring and reporting of aclinical trial against regulatory requirements; further types ofaudits are: management a. = evaluates the efficiency and economyof a given operation in terms of accounting, purchasing, producing,personnel and research; program a. = evaluates effectivenessby a higher level of authority; a. can also be performed on productionplants and laboratory facilities to ensure adherence to goodmanufacturing practice (GMP) or good laboratory practice(GLP) respectively; → see also acceptable quality level, confidentiality,data quality, establishment inspection report,exit interview, iso/dis 10011-2, medical a.audit certificate Document which certifies that an audit has takenplace; has to be stored together with the audit report in the trialmaster file; → see also data trail.aud