ISCRs may be updated following the initial transmission of an ICSR by submitting a new version of the ICSR. The process for submitting an updated version of the ICSR follows the same process as for the original case, however there are some additional validation rules that apply when submitting an updated version of an ICSR. These are specified in the ICSR business rules. Amended ISCRs submitted with a repeated version number and transmission date will be detected as a duplicate and will not be loaded.
The TGA uses a classification process to manage the versioning of the incoming ICSRs and maintain the entire history of the case reports related to a specific ICSR.
A report may be classified as:
a report describing a case for the first time
a report describing a case at a later time
Nullified Report is a report with the data element casenullification (ICH E2B (R2) A.1.13) set to 'yes'.
Note: After a case has been nullified it can no longer be updated. To resubmit, the ICSR should be submitted as a new ICSR.
To assist with managing duplicates the E2B R2 web service undertakes checks using the Sender's (Case) Safety Report Unique Identifier (A.1.0.1) and the Worldwide unique case identification number (A.1.10) to identify duplicate reports. These checks are specified in the ICSR business rules.
If you are amending a case which was previously sent to the TGA via a different reporting channel such as email or online form, you will need to include the other case identifier details in A.1.11.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.