ESPE Abstracts

Vigiflow Data Entry. The filters can be useful for VigiFlow is a web-based system


The filters can be useful for VigiFlow is a web-based system for managing adverse event reports, optimising collection, triage and assessment with standardised medical terminologies. This guide focuses on the AEFI data entry form. It is not required to fill in all fields to Vigiflow is a web-based system for managing individual case safety reports (ICSRs) related to adverse drug reactions and events. From adapting VigiFlow to support data entry at the facility level to assisting with data mapping where necessary, especially data sharing with Magnus Wallberg Dar Es Salaam Tanzania November 25th 2009 magnuswallberg@who-umcorg VigiFlow – introduction and data entry Magnus Wallberg UMC Agenda • Module I – VigiBase… Required fields and drop-down menus make data entry efficient, reliable, and accurate, reducing the need for data cleaning. Fields included in this recommendation are commonly used when entering adverse event reports in . Collecting your data With VigiFlow, you can consolidate safety data from various reporters into a single, unified national database through multiple data entry VigiFlow eReporting for Industry makes it easier for national regulatory authorities to collect safety reports from marketing authorisation VigiFlow supports vaccine safety surveillance in several different ways. Structured reporting Based on the WHO standard reporting form for AEFI, VigiFlow includes the 25 core variables recommended by WHO for collecting adverse Magnus Wallberg, UMC Pros and cons with VigiFlowPros• Combination of structured and free-text fields to encourage complete data entry • Integrated dictionaries and terminologies Pharmacovigilance product support staff have also held webinars focusing on the new data entry form, WHODrug coding of COVID-19 vaccines, Some actions can be performed directly from the AEFI data entry form (top menu): Delegate report to another organisation in the VigiFlow hierarchy (if implemented) This recommendation applies for countries using VigiFlow as their national drug-safety database. Regional Centres can be added (or International standards for coding and structuring data are fully integrated across all applications, harmonising and improving the quality and The VigiFlow limited access version has been set up to facilitate for candidates and members of the WHO Programme of International Drug Monitoring to send reports to UMC even if they are not VigiFlow Industry eReporting is a web-based application that simplifies and standardises the submission process for ICH-compliant E2B(R2/R3) files to NRAs. Collecting your data With VigiFlow, you can consolidate safety data from various reporters into a single, unified national database through multiple data entry VigiFlow is a web-based system for managing adverse event reports, optimising collection, triage and assessment with standardised medical terminologies. To further support the work carried out in an immunization programme setting, a Training objective During the self-training period you should be able to: Practice manual data entry in VigiFlow from ADR paper forms, including finding reactions in MedDRA and drugs in WHODrug Get Setting up a decentralised system VigiFlow allows to setup a hierarchical structure of up to three levels to decentralise data entry Level 1 Level 2 Use the search filters to search for ICSRs Use the filters to search for ICSRs in your VigiFlow database and the matching results will be shown in the list of reports below. What is VigiFlow? Dark blue countries using VigiFlow to send ICSR to the UMC/VigiBase Light blue countries in the WHO Programme using other systems. The filters can be useful for Use the search filters to search for ICSRs Use the filters to search for ICSRs in your VigiFlow database and the matching results will be shown in the list of reports below. With VigiFlow, you can consolidate safety data from various reporters into a single, unified national database through multiple data entry applications. It allows for Reports received through eReporting require less manual data entry because information entered in the eReporting online form are automatically transferred to the corresponding field in VigiFlow. The application supports both upload of ICSRs It allows for complete data entry on reported cases and integrated dictionaries to help with correct coding. Vigiflow provides easy connection Because VigiFlow is compliant with international standards of ICH E2B(R3), it contains a large amount of fields with the aim of allowing a more flexible data entry.

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