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Risk Analysis Interview IVDR 2023

NCT06105086 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-05-09

No results posted yet for this study

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 compliance with the European in vitro diagnostics regulation (EU IVDR 2017/746). To construct the dataset, semi-structured interviews will be conducted to assess the clinical hazards of the in-house in vitro diagnostic test assessments, their degree of significance and their importance with respect to clinical performance, as determined by the opinions of field specialists.

Conditions

  • Risk Variables

Interventions

OTHER

Semi-structured interview

Participants will be asked pre-defined questions and are allowed to elaborate on the subject.

Sponsors & Collaborators

  • Vrije Universiteit Brussel

    collaborator OTHER

  • Universitair Ziekenhuis Brussel

    lead OTHER

Principal Investigators

  • Johan Guns, Prof. · UZ Brussel Laboratorium Kwaliteit

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2024-02-20
Completion
2024-04-28

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06105086 on ClinicalTrials.gov