RDC for monitors

Instructions for using the VISTA RDC system intended for monitors

Transcript

1. VISTA RDC rdc.eortc.be EORTC Remote Data Capture System For monitors working on trials with RDC monitoring
2. What 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-friendly • Runs in a standard web browser (internet) • Does not require installation of any specific software
3. RDC is not used for … • Patient registration • Reporting SAE • QoL forms • …
4. RDC monitoring • Monitors can create electronic CRA queries and can electronically tick forms as source data verified • The 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 Manager • Source 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'
6. Log-In page http://rdc.eortc.be • Documentation • Account • study / patients • ‘Monitor’ rights (RDC access request form) • Login
7. Main page Study box contains « your » studies
8. List of patients List of « your » patients appears automatically after study selection Move to the next / previous page (25 pts per page)
9. Patients’ status overview • nb of patients with queries • nb of patients waiting monitoring Click on the blue text to display the list of these patients
10. Select a patient OR
11. CRF status • Blank tab: contains for the site the forms to be completed  No information as not applicable for the monitor • Incomplete tab: forms with status ‘incomplete’ (not final yet)  Can be viewed by the monitor • Complete tab: forms ready to be sent by the site • Sent tab: forms sent by the site  Source data verification  Create CRA queries in case of inconsistencies
12. Monitoring status • Not done: source data verification by the Monitor is not done • Done: source data verification by the Monitor is done • Queries: number of (un) answered queries • By clicking on 'not done', 'done' or 'queries' in the monitoring column, a form can be source data verified and CRA queries can be created
13. Save a CRF to PDF • Forms can be saved as PDF document • To do this: • Open the form in view-mode • Click on save as PDF • Pick up the PDF • PDF document is displayed and can be printed or saved
14. Source 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
15. CRA 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'
16. CRA queries (2) • The query question should be typed in the 'question' field and should be saved • The CRA query is automatically sent to the principal investigator (or an authorized staff member), but can still be deleted in case of mistakes
17. Request for help • If you encounter a technical problem, contact the EORTC webmaster (rdc@eortc.be) • For protocol related questions, contact the EORTC Data Manager