NCT06105086

Risk Analysis Interview IVDR 2023

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

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. Various In-house in vitro diagnostic tests (IH-IVDs) will be selected, that are classified under different categories according to the risk management in the new IVDR. Two interviews will be conducted for each test. These interviews will engage a laboratory technician and a medical expert specialized in that particular test. The purpose of these interviews is to gather data on the variables that contribute to the risks of IH-IVDs and their impact on clinical diagnosis and patient outcomes. The obtained results will be applied in creating a decision tree using a pre-validated algorithm. The semi-structured interviews feature pre-determined questions that allow participants to share their experiences and opinions within their area of expertise. Each interview is expected to last between thirty minutes to an hour. If consent is given, the interviews will be recorded but not published or shared. In accordance with the confidentiality policy, all data collected will be kept anonymous.

Conditions

• Risk Variables

Interventions

Type	Name	Description
OTHER	Semi-structured interview	Participants will be asked pre-defined questions and are allowed to elaborate on the subject.

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-02-20
• Completion: 2024-04-28
• First posted: 2023-10-27
• Last updated: 2024-05-09

Locations

1 site across 1 country: Belgium