VI.App.7.2. Duplicate detection in EudraVigilance – Collaboration between the Agency, competent authorities in Member States and marketing authorisation holders– Duplicate ICSRs submitted to EudraVigilance by different senders and identified by the Agency
Location:
VI. Appendix 7
Figure VI.9. 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 submitted to EudraVigilance by different senders and identified by the Agency. See steps description in Table VI.15.
Table VI.15. Process description – Duplicate Detection (DD) in EudraVigilance – Collaboration between the Agency, competent authorities in Member States (NCAs) and marketing authorisation holders (MAHs) – Duplicate ICSRs submitted to EudraVigilance by different senders and identified by the Agency. See process map in Figure VI.9.
| No. | Step | Description | Responsible Organisation |
| Start. | EudraVigilance (EV) Duplicate Detection with duplicates originating from different Senders – Duplicates identified by the Agency
Example: there is more than one suspect drug and the same case is submitted to EV by two senders; the patient reported the same adverse reaction to a NCA and the MAH. |
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| 1 | EudraVigilance DD Algorithm. | A duplicate detection algorithm is operated in EudraVigilance to detect potential duplicate ICSRs. Go to step 2. | EMA |
| 2 | EMA DD Management Process. | The potential duplicate ISCRs identified by the EudraVigilance duplicate detection algorithm are reviewed in accordance with the applicable SOP and WINs. Go to step 2.1. | EMA |
| 2.1 | Are duplicate ICSRs confirmed by EMA? | Are the potential duplicate ICSRs identified by the EudraVigilance duplicate detection algorithm confirmed?
If Yes, proceed to step 3. If No, proceed to step 4. |
EMA |
| 3 | Are the duplicate ICSRs from the same sender? | Are the duplicate ICSRs from the same sender organisation (NCA or MAH)?
If Yes, proceed as outlined in Figure VI.8 and Table VI.14 for the management of duplicate ICSRs submitted to EudraVigilance by the same sender and identified by the Agency. If No, proceed to step 5. |
EMA |
| 4 | Duplicates not confirmed by EMA. | The potential duplicate ICSRs have been reviewed and are not considered as duplicate of a single case. Go to step 4.1 | EMA |
| 4.1 | EMA to record outcome of duplicate management. | The outcome of the duplicate detection management process is recorded in accordance with the applicable SOP and WINs. Go to step 4.2. | EMA |
| 4.2 | End. | EMA | |
| 5 | Is further information required? | Is further information necessary from the senders’ organisations to confirm if the potential duplicate ICSRs identified by the duplicate detection algorithm are duplicates?
If Yes, proceed to step 6. If No, proceed to step 7 |
EMA |
| 6 | EMA to contact Senders’ organisations (MAH/NCA). | Contact the senders’ organisations to obtain additional information on the individual cases that have been identified as potential duplicate ICSRs. Go to step 8. | EMA |
| 7 | Duplicate ICSRs confirmed. | The ICSRs are confirmed as duplicate of a single case. Go to step 7.1. | EMA |
| 7.1 | EMA to merge duplicate ICSRs and create master case. | EMA merges the duplicate ICSRs in line with the guidance provided in GVP Module VI Addendum I – Duplicate management of adverse reaction reports. Go to step 7.2. | EMA |
| 7.2 | EMA to inform senders’ organisations about master case. | EMA informs the senders’ organisations (MAH/NCA) about the outcome of the duplicate management (creation of master case) to allow them to take action where necessary66;67;68 . Go to step 7.3. | EMA |
| 7.3 | Senders’ organisations to administrate duplicate ICSRs locally. | The senders’ organisations of the individual cases identified as duplicate ICSRs manage the duplicate ICSRs locally in line with the guidance provided in GVP Module VI Addendum I – Duplicate management of adverse reaction reports. The reference numbers of the duplicate ICSRs and of EMA master case are captured in data element ‘Other case identifiers in previous transmissions’ (ICHE2B(R2) A.11/ ICH-E2B(R3) section C.1.9.1.). Go to step 7.4. | Sender organisations (MAH/NCA) |
| 7.4 | End. | Sender organisations (MAH/NCA) | |
| 8 | Have senders’ organisations provided information? | Check if the sender’s organisations have provided the requested information?
If Yes, proceed to step 9. If No, proceed back to step 6. |
EMA |
| 9 | EMA to review requested info. | Review the potential duplicate ICSRs together with the requested information provided by the senders’ organisations. Go to step 10. | EMA |
| 10 | Are duplicate ICSRs confirmed? | Are the potential duplicate ICSRs confirmed following the receipt of the requested information from the sender’s organisations?
If Yes, proceed to step 11. If No, proceed to step 12 |
EMA |
| 11 | Duplicate ICSRs confirmed. | The ICSRs are confirmed as duplicate of a single case. Go to step 11.1. | EMA |
| 11.1 | EMA to merge duplicate ICSRs and create master case. | EMA merges the duplicate ICSRs in EudraVigilance in line with the guidance provided in GVP Module VI Addendum I – Duplicate management of adverse reaction reports. Go to step 11.2. | EMA |
| 11.2 | EMA to inform senders’ organisations about master case. | EMA informs the senders’ organisations (MAH/NCA) about the outcome of the duplicate management (creation of master case) to allow them to take action where necessary69;70;71 . Go to step 11.3. | EMA |
| 11.3 | Senders’ organisations to administrate duplicate ICSRs locally. | The senders’ organisations of the individual cases identified as duplicate ICSRs manage the duplicate ICSRs locally in line with the guidance provided in GVP Module VI Addendum I – Duplicate management of adverse reaction reports. The reference numbers of the duplicate ICSRs and of EMA master case are captured in data element ‘Other case identifiers in previous transmissions’ (ICHE2B(R2) A.11/ ICH-E2B(R3) section C.1.9.1.). Go to step 11.4. | Sender organisations (MAH/NCA) |
| 11.4 | End. | Sender organisations (MAH/NCA) | |
| 12 | Duplicate ICSRs not confirmed. | The potential duplicate ICSRs are not considered as duplicate of a single case based on the review of the information provided by the senders’ organisations. Go to step 12.1. | EMA |
| 12.1 | EMA to record outcome of duplicate management. | The outcome of the duplicate management process is recorded in accordance with the applicable SOP and WINs. Go to step 12.2. | EMA |
| 12.2 | End. | Follow-up information has been obtained for the nonvalid ICSR. Go to step 11.1. | EMA |