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Vergleich","/FAQ/comparison-cloud","99.FAQ/10.comparison-cloud","/FAQ/comparison-cloud/","/faq/comparison-cloud",{"title":1120,"path":1121,"stem":1122,"tags":6,"slug":1123,"sourcePath":1124},"SetFN vs. NAS im Vergleich","/FAQ/comparison-nas","99.FAQ/20.comparison-nas","/FAQ/comparison-nas/","/faq/comparison-nas",{"title":1126,"path":1127,"stem":1128,"tags":6,"slug":1129,"sourcePath":1130},"Sicherheitsrichtlinie","/FAQ/security-policy","99.FAQ/30.security-policy","/FAQ/security-policy/","/faq/security-policy",{"title":1132,"path":1133,"stem":1134,"tags":6,"slug":1135,"sourcePath":1136},"Warum SetFN so schnell ist","/FAQ/why-fast","99.FAQ/40.why-fast","/FAQ/why-fast/","/faq/why-fast",{"title":1138,"path":1139,"stem":1140,"tags":6,"slug":1141,"sourcePath":1142},"Lizenz-FAQ","/FAQ/license-faq","99.FAQ/50.license-faq","/FAQ/license-faq/","/faq/license-faq",{"title":1144,"path":1145,"stem":1146,"tags":6,"slug":1147,"sourcePath":1148},"FAQ zu KI-Funktionen","/FAQ/ai-faq","99.FAQ/60.ai-faq","/FAQ/ai-faq/","/faq/ai-faq",{"title":1150,"path":1151,"stem":1152,"tags":6,"slug":1153,"sourcePath":1154},"Leitfaden zur Fehlerbehebung","/FAQ/troubleshooting","99.FAQ/70.troubleshooting","/FAQ/troubleshooting/","/faq/troubleshooting",{"id":1156,"title":1059,"body":1157,"cover":6,"description":1336,"extension":1337,"image":6,"meta":1338,"navigation":1339,"path":1060,"reviewSummary":6,"reviewedAt":6,"seo":1340,"slug":1062,"stem":1061,"tags":6,"thumbnail":6,"thumbnailPosition":6,"thumbnailScale":6,"__hash__":1350},"docs_de/50.plugin/50.edc/10.data-entry.md",{"type":1158,"value":1159,"toc":1324},"minimal",[1160,1165,1169,1172,1177,1180,1187,1191,1194,1200,1204,1207,1212,1216,1223,1242,1248,1252,1265,1271,1283,1289,1298,1302,1307,1311],[1161,1162,1164],"h1",{"id":1163},"dateneingabe-und-änderungsverlauf-audit-trail","Dateneingabe und Änderungsverlauf (Audit Trail)",[1166,1167,1168],"p",{},"Der Kern eines EDC-Systems ist, den Änderungsverlauf der Daten festzuhalten (Audit Trail). Für alle Aktivitäten wie Dateneingabe, Änderung, Verifizierung und Queries wird protokolliert, wer wann was getan hat.\nDamit ist die Rückverfolgbarkeit (traceability) gewährleistet, die Vorschriften wie GCP (Gute Klinische Praxis) und 21 CFR Part 11 verlangen.",[1170,1171],"hr",{},[1173,1174,1176],"h2",{"id":1175},"dateneingabe","Dateneingabe",[1166,1178,1179],{},"Wählen Sie unter Subjects einen Probanden und anschließend im CRF-Formularbaum ein Element aus, um einen Wert einzugeben. Zu jedem Element wird die Anzahl der System-Queries, manuellen Queries und Änderungen angezeigt.",[1166,1181,1182],{},[1183,1184],"img",{"alt":1185,"src":1186},"Dateneingabeseite","./_screenshots/edc-main_de.png",[1173,1188,1190],{"id":1189},"datenverifizierung-sdv-source-data-verification","Datenverifizierung (SDV, Source Data Verification)",[1166,1192,1193],{},"Prüfen Sie, ob die eingegebenen Daten mit den Quelldokumenten übereinstimmen (SDV), und schließen Sie die Verifizierung ab. Auch beim Aufheben der SDV erscheint ein Bestätigungsdialog mit dem ausdrücklichen Hinweis „Diese Aktion wird im Audit Log protokolliert“.\nOb eine SDV durchgeführt wurde, unterliegt selbst der Prüfung.",[1166,1195,1196],{},[1183,1197],{"alt":1198,"src":1199},"Bestätigung beim Aufheben der SDV","./_screenshots/edc-sdv-popup.png",[1173,1201,1203],{"id":1202},"query","Query",[1166,1205,1206],{},"Bestehen Zweifel an den Daten, legen Sie eine Query an. Queries sind in die Tabs Manual (manuell angelegt), System (automatisch vom System erzeugt) und Closed (geschlossene Queries) unterteilt; wenn Sie eine Query beantworten und bestätigen, wird auch das im Verlauf festgehalten.",[1166,1208,1209],{},[1183,1210],{"alt":1203,"src":1211},"./_screenshots/edc-query_de.png",[1173,1213,1215],{"id":1214},"sammelaktionen","Sammelaktionen",[1166,1217,1218,1219,1222],{},"Im Menü ",[1220,1221,1215],"code",{}," oben rechts im CRF-Bildschirm können Sie Folgendes erledigen.",[1224,1225,1226,1230,1233,1236,1239],"ul",{},[1227,1228,1229],"li",{},"SDV abschließen / SDV aufheben",[1227,1231,1232],{},"Freezing / Freezing aufheben (Vorankündigung der Datensperre)",[1227,1234,1235],{},"Lock / Lock aufheben (Bearbeitung sperren)",[1227,1237,1238],{},"Alle bearbeiten",[1227,1240,1241],{},"Standardfragen zurücksetzen (Grund erforderlich)",[1166,1243,1244],{},[1183,1245],{"alt":1246,"src":1247},"Sammelaktionen – Daten zurücksetzen","./_screenshots/edc-data-reset.png",[1173,1249,1251],{"id":1250},"audit-trail-prüfen","Audit Trail prüfen",[1224,1253,1254],{},[1227,1255,1256,1260,1261,1264],{},[1257,1258,1259],"strong",{},"Verlauf je Feld",": Im ",[1220,1262,1263],{},"Bearbeitungsverlauf"," des Elements sehen Sie Änderungsinhalt, Bearbeiter und Zeitpunkt.",[1166,1266,1267],{},[1183,1268],{"alt":1269,"src":1270},"Bearbeitungsverlauf eines Felds","./_screenshots/edc-audit-log_de.png",[1224,1272,1273],{},[1227,1274,1275,1278,1279,1282],{},[1257,1276,1277],{},"Gesamtverlauf je Proband",": Unter ",[1220,1280,1281],{},"Aktivitätsprotokolle"," sehen Sie alle Aktivitäten zu diesem Probanden (Dateneingabe, Änderung, SDV usw.) in zeitlicher Reihenfolge.",[1166,1284,1285],{},[1183,1286],{"alt":1287,"src":1288},"Aktivitätsprotokoll des Probanden","./_screenshots/edc-action-log.png",[1290,1291,1292],"warning",{},[1166,1293,1294,1297],{},[1257,1295,1296],{},"Geben Sie bei schwer rückgängig zu machenden Aktionen wie dem Zurücksetzen von Daten oder Lock einen eindeutigen Grund an."," Alle Aktionen bleiben im Audit Trail erhalten.",[1173,1299,1301],{"id":1300},"hinweise","Hinweise",[1224,1303,1304],{},[1227,1305,1306],{},"Gesperrte (Lock) Daten können erst nach Aufheben der Sperre bearbeitet werden.",[1173,1308,1310],{"id":1309},"verwandte-dokumente","Verwandte Dokumente",[1224,1312,1313,1319],{},[1227,1314,1315],{},[1316,1317,1054],"a",{"href":1318},"./overview",[1227,1320,1321],{},[1316,1322,1064],{"href":1323},"./builder",{"title":1325,"searchDepth":1326,"depth":1327,"links":1328},"",2,3,[1329,1330,1331,1332,1333,1334,1335],{"id":1175,"depth":1326,"text":1176},{"id":1189,"depth":1326,"text":1190},{"id":1202,"depth":1326,"text":1203},{"id":1214,"depth":1326,"text":1215},{"id":1250,"depth":1326,"text":1251},{"id":1300,"depth":1326,"text":1301},{"id":1309,"depth":1326,"text":1310},"Erläutert die Kernfunktion von EDC: Daten werden in das CRF eingegeben, und jede Änderung bleibt als Audit Trail erhalten.","md",{},true,{"title":1341,"description":1336,"ogType":1342,"twitterCard":1343,"keywords":1344},"Dateneingabe, Audit Trail | Plugin Docs","article","summary_large_image",[1059,1345,1346,1176,1203,1347,1348,1349],"EDC","Audit Trail","SDV","Datenverifizierung","SetFN-Plugin","plXgJ1paAV3fPmRokEjgV1lItw7RkWk0UM3oj-moA60",[1352,1353],{"title":1054,"path":1055,"stem":1056,"slug":1057,"children":-1},{"title":1064,"path":1065,"stem":1066,"slug":1067,"children":-1},{"title":1059,"filename":1355,"content":1356},"data-entry","# Dateneingabe und Änderungsverlauf (Audit Trail)\n\nDer Kern eines EDC-Systems ist, den Änderungsverlauf der Daten festzuhalten (Audit Trail). Für alle Aktivitäten wie Dateneingabe, Änderung, Verifizierung und Queries wird protokolliert, wer wann was getan hat. \nDamit ist die Rückverfolgbarkeit (traceability) gewährleistet, die Vorschriften wie GCP (Gute Klinische Praxis) und 21 CFR Part 11 verlangen.\n\n---\n\n## Dateneingabe\n\nWählen Sie unter Subjects einen Probanden und anschließend im CRF-Formularbaum ein Element aus, um einen Wert einzugeben. Zu jedem Element wird die Anzahl der System-Queries, manuellen Queries und Änderungen angezeigt.\n\n![Dateneingabeseite](./_screenshots/edc-main_de.png)\n\n## Datenverifizierung (SDV, Source Data Verification)\n\nPrüfen Sie, ob die eingegebenen Daten mit den Quelldokumenten übereinstimmen (SDV), und schließen Sie die Verifizierung ab. Auch beim Aufheben der SDV erscheint ein Bestätigungsdialog mit dem ausdrücklichen Hinweis „Diese Aktion wird im Audit Log protokolliert“. \nOb eine SDV durchgeführt wurde, unterliegt selbst der Prüfung.\n\n![Bestätigung beim Aufheben der SDV](./_screenshots/edc-sdv-popup.png)\n\n## Query\n\nBestehen Zweifel an den Daten, legen Sie eine Query an. Queries sind in die Tabs Manual (manuell angelegt), System (automatisch vom System erzeugt) und Closed (geschlossene Queries) unterteilt; wenn Sie eine Query beantworten und bestätigen, wird auch das im Verlauf festgehalten.\n\n![Query](./_screenshots/edc-query_de.png)\n\n## Sammelaktionen\n\nIm Menü `Sammelaktionen` oben rechts im CRF-Bildschirm können Sie Folgendes erledigen.\n\n- SDV abschließen / SDV aufheben\n- Freezing / Freezing aufheben (Vorankündigung der Datensperre)\n- Lock / Lock aufheben (Bearbeitung sperren)\n- Alle bearbeiten\n- Standardfragen zurücksetzen (Grund erforderlich)\n\n![Sammelaktionen – Daten zurücksetzen](./_screenshots/edc-data-reset.png)\n\n## Audit Trail prüfen\n\n- **Verlauf je Feld**: Im `Bearbeitungsverlauf` des Elements sehen Sie Änderungsinhalt, Bearbeiter und Zeitpunkt.\n\n![Bearbeitungsverlauf eines Felds](./_screenshots/edc-audit-log_de.png)\n\n- **Gesamtverlauf je Proband**: Unter `Aktivitätsprotokolle` sehen Sie alle Aktivitäten zu diesem Probanden (Dateneingabe, Änderung, SDV usw.) in zeitlicher Reihenfolge.\n\n![Aktivitätsprotokoll des Probanden](./_screenshots/edc-action-log.png)\n\n::warning\n**Geben Sie bei schwer rückgängig zu machenden Aktionen wie dem Zurücksetzen von Daten oder Lock einen eindeutigen Grund an.** Alle Aktionen bleiben im Audit Trail erhalten.\n::\n\n## Hinweise\n\n- Gesperrte (Lock) Daten können erst nach Aufheben der Sperre bearbeitet werden.\n\n## Verwandte Dokumente\n\n- [Einführung in EDC](./00.overview.md)\n- [Builder](./20.builder.md)\n",1793056572650]