Status:
COMPLETED
Risk Analysis Interview IVDR 2023
Lead Sponsor:
Universitair Ziekenhuis Brussel
Collaborating Sponsors:
Vrije Universiteit Brussel
Conditions:
Risk Variables
Eligibility:
All Genders
Phase:
NA
Brief Summary
The objective of this research project is to design a risk-based model to decide when clinical performance studies should be performed on in-house developed in vitro diagnostic tests (IH-IVDs) in comp...
Detailed Description
The project's intervention involves conducting semi-structured interviews with clinical laboratory managers and medical professionals. The estimated number of participants for this study is 30. Variou...
Eligibility Criteria
Inclusion
- Work relation with the medical field/hospital
- Achieved a master degree or higher
- Compatible to take an interview independently
Exclusion
- /
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2024
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06105086
Start Date
December 1 2023
End Date
April 28 2024
Last Update
May 9 2024
Active Locations (1)
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1
UZ brussel
Brussels, Belgium, 1090