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?
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?
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?
If CRO does the SUSAR reporting on behalf of several sponsors, should the CRO submit agreement(s) or letter of authority for each sponsor?
Is the ‘identifier’ provided for each study protocol?
For running number ZZZZZ: If a particular report is being followed-up across the calendar year, how should the number be changed?
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?

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