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FAQ : Clinical Trial - Monthly SUSAR Reporting

Is the pilot study applicable to all the current ongoing studies or will it only start from the new studies within year 2018?

It will be for all current ongoing studies.

What is the rationale for the numbering system?

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). 

Is there a need to trace back to the initial year of the report for the purpose of filling Column A in the Excel template?

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).

If CRO is the one who submits the SUSAR(s) on behalf of the sponsor, will the unique identifier be provided to the CRO or the Sponsor?

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). 

If CRO does the SUSAR reporting on behalf of several sponsors, should the CRO submit agreement(s) or letter of authority for each sponsor?

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

Is the ‘identifier’ provided for each study protocol?

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

For running number ZZZZZ: If a particular report is being followed-up across the calendar year, how should the number be changed?

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.  

Once a blinded clinical trial has reached its final stage of unblinding, more data will be added to the case and hence new CIOMS will be generated. Therefore a particular SUSAR report may have been submitted years before and have additional information added. Should the new information be submitted as a follow up SUSAR report?

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).