Infectious Diseases Working Party (IDWP)
COVID-19
Study type:
Study number:
8414139
Type of Stem Cell Treatment:
Allogeneic
Autologous
CAR T
Diseases:
Complications: infectious
Short title:
Covid-19 study
Primary objective:
Key inclusion criteria:
Country:
All EBMT member countries
Principal investigator:
Per Ljungman, Rafael de la Camara, Nicolaus Kröger, Jan Styczynski, Stephan Mielke, Malgorzata Mikulska
EBMT Study coordinator:
Nina Knelange
Study coordinator email:
idwp.ebmt@lumc.nl
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?:
DPIA performed for EBMT Registry (WP & NIS Studies)
Retention Schedule (if possible):
at least 5 years after the final report or first publication of study results