Personal information of sender and primary source
The TGA does not require personal information on the individual in the Sender and Primary Source entities to be included in the ICSR.
Specifically, the following fields are not required to have a value:
- sendertitle (A.3.1.3b)
- sendergivename (A.3.1.3c)
- sendermiddlename (A.3.1.3d)
- senderfamilyname (A.3.1.3e)
- reportertitle (A.2.1.1a)
- reportergivename (A.2.1.1.b)
- reportermiddlename (A.2.1.1c)
- reporterfamilyname (A.2.1.1d)
The E2B R2 EDI service will not store any values from the above fields (if they are provided) within the TGA system.
Privacy statement
For general privacy information, go to the TGA Privacy web page.
Individual Case Safety Reports (ICSRs) are collected to assist in the post market monitoring of the safety of therapeutic goods under the Therapeutic Goods Act 1989. All reports are entered into the Therapeutic Goods Administration's (TGA) Australian Adverse Event Management System. Further information about how the TGA uses adverse event information that is reported to it is available at the TGA Reporting Adverse Events web page.
The TGA collects personal information in ICSRs to:
- monitor the safety of medicines and vaccines under the Act
- contact the sender of the adverse event if further information is required
- contact representatives of entities that supply therapeutic goods, to discuss reported adverse events
- check that the same information has not been received multiple times for the same adverse event.
At times, this information is collected from someone other than the individual to whom the personal information relates. This can occur when an adverse event is reported to a person or an entity other than the TGA (such as a health professional or a hospital), and that person or entity passes the information on to the TGA.
Personal information collected in this report may be disclosed by consent or where the disclosure is required by, or authorised under, a law (for example, under section 61 of the Act). Where a report relates to vaccine events, personal information about the reporter or the patient may be disclosed to State and Territory health agencies under subsection 61(3) of the Act.
It is the TGA's preference that personal information, such as the names of patients, health professionals, or health facilities; date of birth; and patient identification numbers, are not included in the case narrative. This information should instead be provided in the sender comments or other applicable fields.
Data security
Messages sent to and received from the service will be encrypted at both the transport and message levels.
- Transport level encryption is provided by HTTPS.
- Messages will be sent/received via the AS2 specification and will be signed/encrypted using digital certificate-based authentication.