Risk Analysis Interview IVDR 2023

Study Overview
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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.

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.

Official Title
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Risk Analysis Interview IVDR 2023

Conditions
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Risk Variables

Intervention / Treatment
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* Other: Semi-structured interview


Participation Criteria
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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: /
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: medical doctors and clinical laboratory managers<br>Semi-structured interviews | Other: Semi-structured interview<br>* Participants will be asked pre-defined questions and are allowed to elaborate on the subject.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IH-IVD, in-house tests, IVDR 2017/746, Semi-structured interview, Risk analysis