It will be for all current ongoing studies.

The running number is to avoid duplicate reporting of a SUSAR event and as a case identifier to keep track of subsequent follow up report(s).

Yes. Please declare the initial year of report in the last column of the Excel (Column S:Note) for cases with initial report sent before the initiation of this pilot study.

Based on feedback from stakeholder, from the initiation of this pilot study, all reports (initial and follow up) would be considered to start from 2018 to aid the reporting process. Thus the running number would start from this year. The initial date of reporting would need to be declared in the Excel template (Column S:Note).

Based on the requirements of the CTIL and CTX, all communications should go through the license holder. However, acknowledging the fact that PV activities might be outsourced by the sponsor to a third party, we would expect that this function is spelled out in the agreement(s) or Letter of Authority between the sponsor and the third party (in this case CRO). Hence, we will issue the unique identifier according to the sponsor (which originally should be the CTIL/CTX license holder) or delegated party (if applicable).

Yes. We will issue different identifier to the CRO for the reporting activities performed for different sponsors.

The identifier is not provided based on protocols. Rather, it is provided for each sponsor/CRO.

The running number should not change across the calendar year. Only the follow up number would be changed. E.g. For a report submitted in 2018, the running number for the initial report would be ABC1800005-00. For the first follow up report submitted in 2019, the follow up report would be ABC1800005-01.

Yes. However, kindly use the reference number as according to the initial report that this additional data applies to. 

From the initiation of this pilot study, all reports (initial and follow up) would be considered to start from 2018 to aid the reporting process. Thus the running number would start from this year. The initial date of reporting would need to be declared in the Excel template (Column S:Note).