ManagE2B: Adverse event reporting in E2b format

Tracking of adverse events made easy

Find information

Safety reports: A number of search options is available to find a specific or a range of safety reports, using safety report numbers, products, dates, patient characteristics, source, etc.
Cases: Cases are found with the same functionality as used to find safety reports.
Information requests: A number of search options is available to find a specific or a range of info requests, using request numbers, products, dates, requested by, etc.

Case

Case properties: A number of central case properties like case number, authority number (if present), manufacturing defect (number), duplicate (number)
Safety reports: Initial safety report and follow-up reports, belonging to the case and management of safety reports like adding a follow-up report.
Information request: A list of all information requests belonging to the case and management of information requests.
Documents: Documents sent by the reporters of the side effects can be stored in the case folder.
Imported E2b: Side effects, sent as E2b document (for example from safety agencies) can be imported directly and can be found at the case they belong to .
Archiving: When a case is closed is it possible to archive the case (it is no longer shown in the search part of the application), but when needed, it is possible to undo the archiving.
Audit trail: When users change imported parameters, an audit trail is updated with the old and the new value. All audit trail records belonging to a case can be viewed in the Case.

Safety report

Alerts: Safety reports which have passed the alert date are shown as alerts (some action is required). The alert date is based on settings in the application.
Initial report: The initial report is the first report of a case. All fields available in E2b can be used to specify the adverse event.
Follow-up report: When additional information becomes available a follow-up report is required. The follow-up starts as a copy from the previous report and the additonal information is added. The last report is allways the most up-to-date.
Workflow: For the management of a safety report a workflow is used to manage timely reporting.
Seriousness: The seriousness of the side effect affects the reporting because the timelines depend on the seriousness.

Information request

Alerts: Information requests which have passed the alert date are shown as alerts (some action is required). The alert date is based on settings in the application.
Information requests: Requests for additional information from a reporter like a gp, medical specialist, pharmacist, etc. Also the party who has raised the question is included.
Status: The status of each request is managed, is the request anwered and was any information provided? When new information is provided a follow-up safety report is required.
Due date: Each request has a due date. Compliance reporting is using this due date.

Compliance and reporting

Compliance reports: There is a number of compliance reports available to show different compliance parameters on a monthly basis (or any other time period).
Listings: There is a number of listings available in Excel, to show record listings related to compliance reporting, or to select overviews for periods, which can be specified.
Extra: Extra listings are available, showing the custom made listings made on request of the client.

Importing and exporting

E2b import: It is possible to upload E2b reports and to import them.
E2b Export: Each safety report is exported as E2b document and can be downloaded to send it to the "Receiver"
Easy cooperation: Because E2b reports can so easely be imported and exported it is possible to manage safety reports for specific projects (for example a clinical trial managed by a CRO) and to export them to the main database without additional data entry steps.

Maintenance

Lookup lists: A large number of lookup lists can be managed, partly using Meddra code.
Templates: Templates can be made for side effects which occur frequently.
Timelines: Timelines can be set for a number of workflow steps and can be specified per seriousness classification.

Cloud

Hosting: Microsoft Azure (ASP.NET).
Database: SQL Server.
Trialplan B.V. Contact:
Waterlelie 45
8043NZ Zwolle Tel: +31 (0)38 737 00 29
Kvk: 18052389