ADR Report
Infarmed I.P.
According GVP Module VIII - Post-Authorisation safety studies, there is always the involvement of a MAH on a PASS. The reporting of ADR cases under PASS or PAES refers to the GVP Module VI.
When a PASS or PAES has no involvement of a MAH (eg conducted by academic organizations), the GVP VI does not apply, ie the national requirements must be met. A GVP VI revision is expected soon in order to include more information about this situation.
The PASS and PAES protocol should specify what should be notified and the notification obligation is the MAH.
All ICSR shall have completed the study type and should havestudy name and number of the study in the fields corresponding to the identification of the study (E2B (R2) A.2.3).
There are three possible scenarios:
1. ADR cases that the protocol requires the systematic collection and ADR is related to the drug scope of the study:
Report Type (A.1.4 field) - study
Study type (A.2.3.3 field) - Another study
2. ADR cases that the protocol requires the systematic collection and the ADR is not related to the drug scope of the study:
Report Type (A.1.4 field) - spontaneous
3. ADR Cases in which the protocol does not require the systematic collection:
Report Type (A.1.4 field) - spontaneous
The ICSR should be send by electronic transmission in xml format.
For more information refer to the information on:
