Infectious Diseases Working Party (IDWP)
Study type:
Study number:
84140161
Type of treatment:
Allogeneic
Autologous
Diseases:
Complications: infectious
Short title:
NTD after HCT
Primary objective:
What are the clinical characteristics, treatment approaches, and outcomes (overall survival (OS), progression-free survival (PFS, from primary transplant indication, general and NTD-specific NRM) of patients NTDs and related diseases undergoing HCT in EBMT centres?
Key inclusion criteria:
1. Allogeneic and autologous HCT
2. Paediatric AND adult patients
3. Evidence of brucellosis infection
4. Brucellosis infection from 2003
2. Paediatric AND adult patients
3. Evidence of brucellosis infection
4. Brucellosis infection from 2003
Country:
All EBMT member countries
Principal investigator:
Vivak Parkash
EBMT Study coordinator:
Nina Knelange
Study coordinator email:
idwp@ebmt.org
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
Study Specific Questionnaire (MED-C)
Recipients who may access the data:
Leiden Study Unit
Statistical Unit
Investigators
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)
Data Protection Impact Assessments
Rights available to individuals:
Access
Data portability
Rectification
Objection
Deletion
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