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Current Treatment of HCV infection after HSCT

Infectious Diseases Working Party (IDWP)
Study number:
8414107
Type of Stem Cell Treatment:
Allogeneic
Autologous
Diseases:
Complications: infectious
Short title:
HCV study
Primary objective:
Report the treatment approach in patients HCV-RNA+
Key inclusion criteria:
All HCV-RNA positive patients transplanted from anytime until May 2017, followed
Country:
All European countries
Principal investigator:
Malgorzata Mikulska
Study coordinator email:
idwp.ebmt@lumc.nl
EBMT Study Unit:
Leiden Study Unit
Reason for processing personal data:
Patients’ data is needed to be able to identify the patient and calculate age at any time (impact on SAEs and response to clinical medications). Health care personal data is part of the CV collected for evidence of proper qualification for running the trial.
Categories of personal data collected:
DOB/YOB, gender
Medical data already reported to the EBMT Registry
Study Specific Questionnaire (MED-C)
Recipients who may access the data:
Leiden Study Unit
Statistical Unit
3rd-party processors of Personal Data on behalf of EBMT/Service provider:
No

Privacy notices

Article 6 lawful basis for processing personal data:
Article 6.1 (a) - Consent (Collection)
Article 9 basis for processing special category data:
Article 9(2) (a) - Consent (Collection)
Is a Data Protection Impact Assessment required?:
Not performed because Study began before implementation of GDPR
Retention Schedule (if possible):
at least 5 years after the final report or first publication of study results