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

63edly improved” to “aggravated”, although still popular in Japan, aremore and more abandoned; → see also effect, effectiveness.ejection fraction Volume of blood ejected with each beat by theleft ventricle, in relation to enddiastolic volume; normal: 50–80%;→ see also cardiac index.elderly Subjects equal or older than 65 years (EC); there is evidenceof a number of physiological changes in elderly subjects: lean musclemass decreases whereas fat increases by about 20% comparedwith the second decade of life; total body water decreases by 17%,extracellular water by 40%, plasma volume by 8%, organ bloodflow decreases, as does the cardiac index; renal plasma flow andglomerular filtration decrease by about 50% between ages 40and 80 years; multimorbidity becomes also more prominent: themean number of diseases in patients over the age of 65 years is estimatedto be between 3 and 4 in industrialised countries; → seealso geriatric evaluations, health care costs, prescription.electronic case report form (eCRF) data may be recorded eitherfrom source documents or the eCRF may be used as the primarysource document; in any case, data must always remain under thecontrol of the investigator and systems as well as procedures mustbe in place to guarantee that the data are not changed or manipulated;→ see also data transfer, electronic CRF, electronicdata, raw data, source data.electronic data Electronic data can be recorded on a durable electronicmedium such as a hard disk, floppy disk, zip disk, CD-Rom, or tapebut also on non-durable media such as personal digital assistants;volatile data are lost when battery power expires; usually a print-outcannot fully substitute for electronic files as metadata may be lost(e.g., author of the data); a certified copy may be acceptable if it iscreated before the data leave the control of the investigator; → seealso computerised systems, remote data entry, source data.electronic data capture (e-DC) synonymously used with remotedata entry; collecting data in (permanent) electronic form by systemsthat are modem-, web-based or that involve optical characterrecognition, audio text, Interactive Voice Response, graphicalclinicallaboratory or other interfaces with or without a humaninterface; any changes to such data must be subject of a completeaudit trail; → see also computerised systems, remote data entry,source data, Web-based data entry.electronic record FDA: “any combination of text, graphics, data, audio,pictorial, or other information representation in digital formthat is created, modified, maintained, archived, retrieved, or distributedby a computer system” (21 CFR 11); → see also computerisedsystems.ele