Infokiri

Dear Tuberculosis Network members,

This is a formal notification from ECDC concerning a recent request we have received for sharing of indicator-based surveillance data collected and stored in the European Surveillance System (TESSy).

A third-party entity has requested access to specific datasets held by our organization, with the intent of conducting research. This notification serves to inform you about this data request and to solicit any comments or objections you may have.

The organization requesting data: IRCCS Ospedale San Raffaele, Milan

The requester is specifically seeking access to: Case-based data for tuberculosis and isolates-based results available at ECDC.

The variables requested are:

1. Age

2. BeijingGenotype

3. BornReportingCountry

4. CountryOfBirth

5. CountryOfNationality

6. DataSource

7. DateOfDiagnosis

8. DateOfEntryToCountry

9. DateOfNotification

10. ECDCIsolateID

11. EnrolledToTreatment

12. Gender

13. HIVStatus

14. IsolateId

15. MajorSiteOfTB

16. MinorSiteOfTB

17. NationalityReportingCountry

18. Outcome12Months

19. Outcome24Months

20. Outcome36Months

21. Pathogen

22. PlaceOfNotification

23. PlaceOfResidence

24. PrevDiagnosis

25. PrevDiagnosisYear

26. PrevTreatment

27. PrevTreatmentCompletion

28. RecordId

29. RecordType

30. ReportingCountry

31. ResultCulture

32. ResultMicroscopy

33. ResultOtherTest

34. SIR_AMK

35. SIR_BDQ

36. SIR_INH

37. SIR_LVX

38. SIR_RIF

Please note, that ECDC will not release country reported RecordID, age will be aggregated by age groups and dates will be released as quarterly information.

Time period to be covered:

January 2015 – December 2023

Declared objectives and analysis plan:

“Analysis of the genomes and epidemiological/clinical data of MTB strains collected between January 2015 and December 2023 will be performed to define the evolution in time of lineages circulating, resistance profiles, number of transmission clusters (including cross borders clusters), rate of notification in arrival vs origin country, focusing on any relevant difference in TB incidence/prevalence/severity/resistance in the migrant population coming from conflict areas in comparison to local and migrant population coming from non-conflict areas.”.

We have thoroughly reviewed this request for compliance with the ECDC Policy on data submission, access and the use of data within TESSy and Article 4 of Regulation (EC) No 1049/2001 regarding public access to European Parliament, Council and Commission documents, and have identified no issues that would prevent the sharing of this data.

Barring any objections from your side, we intend to share the requested dataset with the third-party in the coming weeks.

Any potential objections should be grounded on Article 4 of Regulation (EC) No 1049/2001. If you have any such concerns, we kindly request that you notify us by 2 September 2024.

If we do not receive any response from your side by this date, we will consider that there are no objections and will proceed with the data sharing.

We appreciate your attention to this matter and look forward to your prompt response.

Best regards,

ECDC TB team