Infectious Diseases Working Party (IDWP)
Study type:
Study number:
8414106
Type of Stem Cell Treatment:
Allogeneic
Autologous
Diseases:
Complications: infectious
Short title:
Gram-negative bacteremia
Primary objective:
To determine the incidence and pattern of antimicrobials resistance among Gram-negative bacteria isolated from blood in HSCT patients during the first 6 months after the transplantation.
Key inclusion criteria:
allo or auto HSCT for all indications for any age
Country:
All EBMT member countries
Principal investigator:
Dina Averbuch
EBMT Study coordinator:
Jennifer Hoek
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