Presentation on theme: "VISTA RDC rdc.eortc.be EORTC Remote Data Capture System"— Presentation transcript:
1VISTA RDC rdc.eortc.be EORTC Remote Data Capture System For monitors working on trials with RDC monitoring
2What is Vista RDC?Vista RDC is the web based Remote Data Capture application designed to enable the investigator, DM or RN to enter and edit data on-line and to send the CRF to the EORTC database.VISTA-RDC:User-friendlyRuns in a standard web browser (internet)Does not require installation of any specific software
3RDC is not used for …Patient registrationReporting SAEQoL forms…
4RDC monitoringMonitors can create electronic CRA queries and can electronically tick forms as source data verifiedThe CRA queries are raised by the Monitor, should be answered by the Principal Investigator (or an authorized staff member) and once answered will be closed by the EORTC Data ManagerSource data verification by the Monitor can be done on 'complete' and 'sent' forms and CRA queries can be created on forms with the same status which are not yet ticked as 'source data verified'
11CRF statusBlank tab: contains for the site the forms to be completed No information as not applicable for the monitorIncomplete tab: forms with status ‘incomplete’ (not final yet)Can be viewed by the monitorComplete tab: forms ready to be sent by the siteSent tab: forms sent by the siteSource data verificationCreate CRA queries in case of inconsistencies
12Monitoring statusNot done: source data verification by the Monitor is not doneDone: source data verification by the Monitor is doneQueries: number of (un) answered queriesBy clicking on 'not done', 'done' or 'queries' in the monitoring column, a form can be source data verified and CRA queries can be created
13Save a CRF to PDF Forms can be saved as PDF document To do this: Open the form in view-modeClick on save as PDFPick up the PDFPDF document is displayed and can be printed or saved
14Source data verification Click on ‘not done’ in the monitoring column (‘complete’ or ‘sent’ tab)All the answers should be verified against the source data. If there are no discrepancies, the form can be ticked as 'source data verified' (SDV)In case of discrepancies with the source data, a CRA query should be created
15CRA queries (1)A CRA query can be created on each field of each form with status 'complete' or 'incomplete' which is not yet ticked as 'source data verified'
16CRA queries (2)The query question should be typed in the 'question' field and should be savedThe CRA query is automatically sent to the principal investigator (or an authorized staff member), but can still be deleted in case of mistakes
17Request for helpIf you encounter a technical problem, contact the EORTC webmasterFor protocol related questions, contact the EORTC Data Manager