2/10 - New GVP requirement that can have an operational and budget impact to anticipate

According to recent GVP module VI Revision 2, from 22 NOV 2017 non-serious ADRs from the market in Europe should be submitted to EMA/Eudravigilance within 90 days. This new updated GVP module also applies to non-interventional studies.


This may have an impact on on-going studies where non-serious ADRs are collected in CRF but not rapidly reported by sites on a case by case basis through an adverse event report form.

Thus, EUCROF PV working group would recommend relevant persons, such as projects managers and data management units to check the modalities of information exchanges with sponsor PV for ADRs.


Operationalisation may include regular study clinical database extractions (e.g. on a monthly basis) in order for PV to review and populate data to the safety database and submit valid cases in due time to the agency (EMA).