Data quality principles of ICSRs
Sponsors must ensure that all information relevant to the balance of benefits and risks of a registered or listed medicine is reported to the TGA in accordance with Australian requirements and recommendations for pharmacovigilance responsibilities of sponsors of medicines, including medical and administrative data related to the adverse event.
ICSRs should include the complete information for an individual case that is available to the sender. This information must be entered in a fully structured format using all applicable and relevant ICH E2B (R2) data elements and terminologies, which should be repeated as necessary. This applies to all types of ICSRs, that is:
- initial information on the case
- reports with follow-up information
- cases highlighted for nullification - ensure that:
- A.1.13: 'Report nullification' is set to 'yes'
- A.1.13.1: 'Reason for nullification' is completed.
Associated documents cannot be submitted using the TGA E2B functionality. Any supporting information related to the individual case should be sufficiently described within A.1.8.2: 'List of documents held by sender'and only provided upon request by the TGA. For adverse event reports from literature, the literature reference must be provided in A.2.2 'Literature reference(s)'and the abstract included in B.5.1 'Case Narrative' if possible.
Any information concerning previous transmissions of the same case from either other senders or by the same sender using a different reporting channel such as email or online form should be provided in the A.1.11 'Other case identifiers in previous transmissions'. This is to aid the detection and management of duplicates.
Date information within the ICSR should follow a logical sequence. For example, for the data element 'Date of start of reaction/event' (B.2.i.4b) it would be expected that the supplied date:
- does not refer to a future date
- is less than or equal to the date of transmission (A.1.3b)
- is greater than or equal to the date of birth of the patient (B.1.2.1b)
- is greater than or equal to the start date (B.4.k.12b) for at least one drug with a drug characterisation role of 1 (suspect) or 3 (interacting).
While complete information is desirable, a minimum set of information is always required for an ICSR to be valid. This applies to all types of ICSRs including initial case reports, and cases to be amended or nullified. Minimum data requirements for ICSR sent to the TGA, including mandatory and conditionally mandatory fields are specified in the TGA specific business rules.
Format of data elements
All the information available should be reported in a fully structured format using the relevant E2B (R2) data elements, applicable standard terminologies and TGA specific business rules.
Standard terminologies used in ICSRs include:
- ISO (country codes (2 character), gender codes and language codes)
- Medical Dictionary for Regulatory Activities (MedDRA)
- Where MedDRA terms are used (for example, medical history, indication, and reaction / event), the same MedDRA version must be used throughout the ICSR.
- UCUM (units of measurement)
- ICH M2 (for example, units and routes of administration).
Please refer to each standard for further information.