VI.App.7.5. Duplicate detection in EudraVigilance – Collaboration between the Agency, competent authorities in Member States and marketing authorisation holders – Duplicate ICSRs identified as part of signal management as outlined in GVP Module IX

Location:

VI. Appendix 7

Figure VI.12. Business process map – Duplicate Detection (DD) in EudraVigilance – Collaboration between the Agency, competent authorities in Member States (NCAs) and marketing authorisation holders (MAHs) – Duplicate ICSRs identified as part of signal management process based on EudraVigilance data. See steps description in Table VI.18.

Table VI.18. Process description – Duplicate Detection (DD) in EudraVigilance – Collaboration between the Agency, competent authorities in Member States (NCAs) and marketing authorisation holders (MAHs) – Duplicate ICSRs identified as part of signal management process based on EudraVigilance data. See process map in Figure VI.12.

No.	Step	Description	Responsible Organisation
	Start.	Duplicates identified as part of signal management as outlined in GVP Module IX. Example: as part of the signal management process based on EudraVigilance data, there may be instances where a signal validator of the Agency, a Member State or a MAH may identify potential duplicate ICSRs.
1	Signal Management process.	Signals are assessed in line with GVP Module IX based on electronic Reaction Monitoring Reports (eRMRs), case line listings and individual case report forms generated by EudraVigilance (EVDAS). Go to step 2.	Signal validator (EMA/ NCA/ MAH)
2	Potential duplicates identified?	As part of the review of a signal there may be individual cases identified that could be potential duplicates from the signal validator’s perspective: If potential duplicates are identified, proceed as outlined under step 3 and step 4. If no potential duplicate are identified, proceed as outlined under step 5.	Signal validator (EMA/ NCA/ MAH)
3	Potential duplicates identified.	Potential duplicates have been identified as part of the review of a signal. Go to step 3.1	Signal validator (EMA/ NCA/ MAH)
3.1	Inform EMA about duplicates.	Inform EMA by email (duplicates@ema.europa.eu) about the potential identified duplicate ICSRs. Go to step 3.2	Signal validator (EMA/ NCA/ MAH)
3.2	EMA to review notification.	EMA to review notification of potential duplicates and initiate duplicate management process. If duplicates are from the same sender organisation, proceed as outlined in Figure VI.8 and Table VI.14. If duplicates are from different sender organisations, proceed as outlined in Figure VI.9 and Table VI.15. Go to step 3.3.	EMA
3.3	EMA to notify signal validator about DD outcome.	EMA informs the signal validator about the outcome of the duplicate management process. Go to step 4.2.	EMA
4	Potential duplicates identified.	Potential duplicates have been identified as part of the signal management activities. Go to step 4.2.	Signal validator (EMA/ NCA/ MAH)
4.1	Proceed with signal management.	Proceed with the review of the signal in line with GVP Module IX guidance. Go to step 4.2.	Signal validator (EMA/ NCA/ MAH)
4.2	Finalise signal management.	Finalise the management of the signal based on duplicate detection management feedback from EMA (step 3.3). Go to step 4.3.
4.3	End.
5	No duplicates identified.	No (potential) duplicates have been identified as part of the review of a signal. Go to step 5.1.	Signal validator (EMA/ NCA/ MAH)
5.1	Proceed with signal management.	Proceed with the review of the signal in line with GVP Module IX guidance. Go to step 5.2.	Signal validator (EMA/ NCA/ MAH)
5.2	End.