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

37tency is determined by the confidence level (e.g. 95%); confidencelimits (CL) should always be reported in case of “negative” trials;95% CL = mean difference ± 1.96 ∞ standard error (difference);90% CL = mean difference ± 1.64 ∞ standard error (difference);→ see also rule of three.confidence limits Upper and lower limit of the range of a confidenceinterval.confidential disclosure agreement (CDA) syn. confidentiality agreement,secrecy agreement; mutual written agreement between twoparties concerning confidentiality of provided information; suchdocuments are routinely used between pharmaceutical companies,companies and contract research organisations, or investigators.confidentiality Regarding trial subjects, EC (III): “maintenance ofthe privacy of trial subjects including their personal identity andall medical information; if data verification procedures demandinspection of such details, this may only be done by a properly authorizedperson; identifiable personal details must always be keptin confidence; the trial subject’s consent to the use of records fordata verification purposes should be obtained prior to the trial andassurance should be given that c. will be maintained”; – regardingmaterial from the sponsor, EC: “maintenance of secrecy ofconfidential information from the sponsor in connection with theplanning, execution, reviewing, auditing or evaluation of a clinicaltrial”.confidentiality agreement → see confidential disclosure agreement.confidentiality of personal data According to the EC guidelines ongood clinical practice (III) it ranks among the responsibilitiesof the investigator to “ensure that the confidentiality of all informationabout subjects is respected by all persons involved …”.configuration → see design.confounder syn. confounding variable, nuisance v., interfering v.;variable that is related to both the outcome and exposure understudy in such a way that it can create a false association or maska real one, e.g. coronary artery disease increases the risk of suddendeath, older patients or patients with a longer duration of diseasemay have a worse prognosis, a non-experimental study witha β-blocker might demonstrate an excess of sudden deaths, or thelabelling phenomenon; thus, even if the drug were efficacious(beneficial), it might appear harmful; in the absence of randomization,i.e. in a non-experimental study, to control for confoundingv., one must be able to measure them; c. are not simply effectmodifiers (which, in contrast, do not bias the overall estimatecon