PV-Works includes a rich library of functions for electronic reporting (“e-reporting”) that ensure a comprehensive and efficient process for report generation, submission and receipt tracking.
Central to e-reporting is a database designed around the ICH E2b guidelines (for human pharmacovigilance) and the eudravigilance and FDA1932 regulation (for veterinary pharmacovigilance).
This enables PV247 to propose the following case data Export in the required XML E-reporting formats:
Human ICH E2b / Eudravigilance:
- EVCTM compatible for clinical trial
- FDA character set variant (ISO 8859-1) is an option
- Both ICH R2 and R3 formats are supported
- EMA Eudravigilance
- FDA HL7
The description below applies to both human and veterinary pharmacovigilance.
In the case data entry phase, you can test the presence of the data entered against the requirements of the intended e-report format to ensure that all mandatory fields have been entered.
Generation and Submission
Creating an XML in the appropriate format is as simple as generating a report. All XML files are tracked so that you can see where and when each case was submitted.
- Creation of a file for a group of cases in a single step
- Sending the exported file directly to the PV247 gateway for immediate submission. Use of the gateway is subject to approval by the receiving authority and may require validation. You can decide to export the XML file locally and submit it via EVWeb to avoid the validation.
Acknowledgement messages can be imported into PV247, which updates the status of each submitted case. These messages indicate that the case has been received and processed successfully by the receiver, give warnings over data quality or report an error indicating a failed submission.
A tracking function allows you to review all submissions across cases.
World-Wide Case Number
On export of a case, PV247 generate a world-wide unique case number unless the case already has been allocated a world-wide case number previously (if it was imported). If the case already has a world-wide case number this is used for all submissions.
Case data received from regulatory authorities and partners can be imported directly into PV247 in the same format as that submitted by you for the cases you have entered. Once imported their data may be edited and reported in the same way as any other case.
Follow up received electronically can also be imported. PV247’s flexible “follow up management” system allows you to review the original case against the changes made in its follow up so that you can decide which elements should be applied.