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Electronic submission of individual case safety reports

Electronic data interchange for ICSR submission using the E2B R2 format

18 October 2019

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Test scenarios to use the E2B standard

The 10 test cases below should be submitted using the TGA validation rules and those in the ICH ISCR DTD as part of the registration process for E2B.

TGA is aware that not all marketing authorisation holders will be running post marketing studies of clinical trials, however all tests need to be carried out. If necessary you can use fictional information so that if you do start running these studies, you won't need to carry out testing again.

Tests

  1. Create an ICSR including details of other drugs, medical history, drug history, narrative (B.5.1) and tests, showing:
    • both the structured medical (B.1.7.1a-1g and B.1.7.2), and drug (B.1.8a – B.1.8g.2) history
    • examples of correctly structured tests (B.3.1a - B.3.1.3 and B.3.2) and show the pharmaceutical forms (B.4.k.7) have been incorporated correctly.
  2. Create a fatal ICSR with cause of death and post mortem details where:
    • seriousness death flag must be yes
    • reaction outcome must be fatal
    • patient death date should be provided (B.1.9.1(a+b))
    • reported cause of death should be provided (B.1.9.2(a+b))
    • autopsy flag (B.1.9.3) should be set to 'yes'
    • autopsy cause of death should be provided (B.1.9.4 (a+b)).
  3. A nullification ICSR:
    • the nullification flag must be set to Yes (A.1.13)
    • the nullification reason (A.1.13.1) must be provided.
  4. A parent-child ICSR where:
    • the child/foetus must be encoded as the patient
    • the parent's details must be provided in the parent's section
    • it is essential that:
      • the child (patient) drug route of administration (B.4.k.8) must be transmammary, transplacental, or other (if parent is male)
      • the parent route of administration is entered (B.4.k.9)
      • data element B.1.10 contains validating parent details (initials, age, sex, weight) as well as any relevant parent history and other details available
  5. A follow-up ICSR to an initial ICSR which you have previously sent:
    • initial report should have the same receive (A.1.6(a+b)) and receipt (A.1.7(a+b)) dates
    • follow-up report must have the same receive date as the initial but the receipt date must be changed to reflect when the follow-up information was received
    • the sender's case safety report unique ID (A.1.0.1) and worldwide case ID (A.1.10) must be identical in both the initial and follow-up reports.
  6. A follow-up ICSR to an initial ICSR which has previously been sent from an alternative sender (for example, alternative company or competent authority) should be:
    • the worldwide case ID (A.1.10) must be the same as was sent by the previous sender of the ICSR
    • the sender's case safety report unique ID (A.1.0.1) will differ
  7. An ICSR from a study where:
    • report type must be 'Report from study' (A.1.4)
    • study type must be 'Other studies' (A.2.3.3)
    • study name and number should be provided (A.2.3.1 and A.2.3.2).
  8. An ICSR based on a literature article where the literature reference (A.2.2) must be provided in Vancouver style.
  9. An ICSR with duplicate details completed (A.1.11.1 and A.1.11.2) to capture:
    • all the safety report IDs that have been used in the past to transmit a case between different organisations
    • all previous paper numbers that have been used in the past, to enable the detection of duplicates if a case had previously been sent on paper (for example, ADRS Case number) and company CIOMS MFR Control numbers.
  10. A suspected unexpected serious adverse reaction (SUSAR) where the:
    • report type must be 'Report from study' (A.1.4)
    • study type must be 'Clinical trials' (A2.3.3)
    • study name must be provided (A.2.3.1)
    • study number must be provided (A2.3.2)
    • patient ID must be provided (B.1.1.1d).

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