Risk Analysis Interview IVDR 2023

NCT06105086 | Completed

• 1 other identifier: 23353_RAI-IVDR23
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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 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

Keywords

IH-IVD; in-house tests; IVDR 2017/746; Semi-structured interview; Risk analysis

Outcome Measures

Primary Outcomes (2)

• Risk attributes of the in-house in vitro diagnostic tests measured with semi-structured interviews

  Risk attributes of the in-house in vitro diagnostic tests are the variables that have an impact on the clinical diagnosis and patient outcome. This will be measured with a semi-structured interview with medical doctors and laboratory managers.

  1 hour

• risk impact of the in-house in vitro diagnostic tests measured with semi-structured interviews

  With the opinions and experience of professionals in the field of interest, the risk impact of the in-house in vitro diagnostic tests will be measured with semi-structured interviews. The impact defines the severity or importance of the risk attributes.

  1 hour

Study Arms (1)

medical doctors and clinical laboratory managers

EXPERIMENTAL

Semi-structured interviews

Other: Semi-structured interview

Interventions

Semi-structured interview OTHER

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

medical doctors and clinical laboratory managers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Work relation with the medical field/hospital
• Achieved a master degree or higher
• Compatible to take an interview independently

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• Vrije Universiteit Brussel: collaborator

Study Sites (1)

UZ brussel

Brussels, 1090, Belgium

Location

Study Officials

• Johan Guns, Prof.

  UZ Brussel Laboratorium Kwaliteit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 27, 2023
• Study Start: December 1, 2023
• Primary Completion: February 20, 2024
• Study Completion: April 28, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)