Risk Analysis Interview IVDR 2023 (RAI-IVDR23)

Universitair Ziekenhuis Brussel

Status: Completed

Conditions: Risk Variables

Treatments: Other: Semi-structured interview

Study type: Interventional

Funder types: Other

Identifiers

NCT06105086

23353_RAI-IVDR23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

/

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

medical doctors and clinical laboratory managers

Experimental group

Description:

Semi-structured interviews

Treatment:

Other: Semi-structured interview