VI.App.2.11. Examples for the submission as ICSRs of suspected adverse reactions described in the medical literature and referring to more than one patient

Location:
VI. Appendix 2

Table VI.5. Examples for the submission as ICSRs of suspected adverse reactions described in the medical literature and referring to more than one patient

Ex. Scenario Action
1 A literature article describes suspected adverse reactions that have been experienced by more than one identifiable patient.

ICSRs should be created and submitted for each individual identifiable patient described in the literature article.

Each ICSR should contain all the available information on the case.

The cross reference with all the linked ICSRs from this literature article should only be provided in the first submitted ICSR, in the data element ICH-E2B(R2) A.1.12 ‘Identification number of the report which is linked to this report’. There is no need to repeat all the cross references in the other ICSRs.

 For the ICSRs which relate to the same literature article, the cross reference in the data element ICH (E2B(R2) A.1.12/ ICH-E2B(R3) C.1.10.r ‘Identification number of the report which is linked to this report’ should be conducted as follows:

  • The first case should be linked to all other cases related to the same article (1-n);
  • All the other cases (n) should be only linked to the first one, as in the example below.

Example for the submission of cases originally described in the medical literature referring to a large number of patients:

For case 1 described in the literature article:

  • data element ICH-E2B(R2) A.1.10.1/ ICH-E2B(R3) C.1.8.1 ‘Worldwide Unique Case Identification Number’: UK-ORGABC-0001
  • data element ICH-E2B(R2) A.1.12/ ICH-E2B(R3) C.1.10.r ‘Identification number of the report which is linked to this report’: UK-ORGABC-0002
  • data element ICH-E2B(R2) A.1.12/ ICH-E2B(R3) C.1.10.r ‘Identification number of the report which is linked to this report’: UK-ORGABC-0003
  • data element ICH-E2B(R2) A.1.12/ ICH-E2B(R3) C.1.10.r ‘Identification number of the report which is linked to this report’: UK-ORGABC-0004
  • data element ICH-E2B(R2) A.1.12/ ICH-E2B(R3) C.1.10.r ‘Identification number of the report which is linked to this report’: UK-ORGABC-000N
  • data element ICH-E2B(R2) A.2.2/ ICH-E2B(R3) C.4.r. ‘Literature reference(s)’: Literature reference in line with uniform requirements for manuscripts submitted to biomedical journals including DOI if available: e.g. “N Engl J Med 1997; 336:309-15. doi:10.1056/NEJM199701233360422“  Copy of literature article/translation: follow steps as outlined in Table VI.4.

For Case 2 described in the literature article:

  • data element ICH-E2B(R2) A.1.10.1/ ICH-E2B(R3) C.1.8.1 ‘Worldwide Unique Case Identification Number’: UK-ORGABC-0002
  • data element ICH-E2B(R2) A.1.12/ ICH-E2B(R3) C.1.10.r ‘Identification number of the report which is linked to this report’: UK-ORGABC-0001
  • data element ICH-E2B(R2) A.2.2/ ICH-E2B(R3) C.4.r. ‘Literature reference(s)’: Literature reference in line with uniform requirements for manuscripts submitted to biomedical journals including DOI if available: e.g. „N Engl J Med 1997; 336:309-15. doi:10.1056/NEJM199701233360422“
  • No copy of the literature article required since the copy was already submitted for case 1.

For Case N described in the literature article:

  • data element ICH-E2B(R2) A.1.10.1/ ICH-E2B(R3) C.1.8.1 ‘Worldwide Unique Case Identification Number’: UK-ORGABC-000N
  • data element ICH-E2B(R2) A.1.12/ ICH-E2B(R3) C.1.10.r ‘Identification number of the report which is linked to this report’: UK-ORGABC-0001
  • data element ICH-E2B(R2) A.2.2/ ICH-E2B(R3) C.4.r. ‘Literature reference(s)’: Literature reference in line with uniform requirements for manuscripts submitted to biomedical journals including DOI if available: e.g. „N Engl J Med 1997; 336:309-15. doi:10.1056/NEJM199701233360422“
  • No copy of the literature article required since the copy was already submitted for case 1.