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Risk Analysis Interview IVDR 2023

NCT ID: NCT06105086

Last Updated: 2024-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-04-28

Brief Summary

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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.

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Detailed Description

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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

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Risk Variables

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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medical doctors and clinical laboratory managers

Semi-structured interviews

Group Type EXPERIMENTAL

Semi-structured interview

Intervention Type OTHER

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

Interventions

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Semi-structured interview

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

/
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vrije Universiteit Brussel

OTHER

Sponsor Role collaborator

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Johan Guns

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Johan Guns, Prof.

Role: PRINCIPAL_INVESTIGATOR

UZ Brussel Laboratorium Kwaliteit

Locations

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UZ brussel

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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23353_RAI-IVDR23

Identifier Type: -

Identifier Source: org_study_id

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