Risk VariablesRAI-IVDR23NCT06105086
Risk Analysis Interview IVDR 2023
A study testing Semi-structured interview in people with Risk Variables, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Risk Variables
- What is being tested?
- Semi-structured interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2023to 28 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Work relation with the medical field/hospital
- Achieved a master degree or higher
- Compatible to take an interview independently
Who cannot join
- /
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Semi-structured interview
- Keywords
- IH-IVD, in-house tests, IVDR 2017/746, Semi-structured interview, Risk analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviewOther
Participants will be asked pre-defined questions and are allowed to elaborate on the subject.
| Study group | Role | What they receive |
|---|---|---|
| medical doctors and clinical laboratory managers | Experimental | Semi-structured interviews Receives: Other: Semi-structured interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Dec 2023
- Primary completion20 Feb 2024
- Study completion28 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk VariablesStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Vrije Universiteit Brussel
- Responsible party
- Principal investigator, Johan Guns, Universitair Ziekenhuis Brussel
- Investigators
- Johan Guns, Prof., Principal investigator, UZ Brussel Laboratorium Kwaliteit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105086
- Sponsor's protocol ID
- 23353_RAI-IVDR23
- Acronym
- RAI-IVDR23
- Status last verified
- May 2024
- First submitted
- 10 Oct 2023
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Everything that potentially is going to be shared is anonymous.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Analysis Interview IVDR 2023
- ClinicalTrials.gov ID
- NCT06105086
- Acronym / sponsor ID
- RAI-IVDR23 / 23353_RAI-IVDR23
- Conditions
- Risk Variables
- Keywords
- IH-IVD, in-house tests, IVDR 2017/746, Semi-structured interview, Risk analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- Vrije Universiteit Brussel
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 28 Apr 2024 (actual)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| medical doctors and clinical laboratory managers | Experimental | Other: Semi-structured interviewSemi-structured interviews |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Work relation with the medical field/hospital
- Achieved a master degree or higher
- Compatible to take an interview independently
Key exclusion criteria (1 listed)
- /
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi-structured interviewParticipants will be asked pre-defined questions and are allowed to elaborate on the subject. | Other | medical doctors and clinical laboratory managers |
Primary outcome
Risk attributes of the in-house in vitro diagnostic tests measured with semi-structured interviews
Time frame: 1 hour
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.
risk impact of the in-house in vitro diagnostic tests measured with semi-structured interviews
Time frame: 1 hour
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No. Everything that potentially is going to be shared is anonymous.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan Guns, Prof. principal investigator
UZ Brussel Laboratorium Kwaliteit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semi-structured interview in people with Risk Variables, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk attributes of the in-house in vitro diagnostic tests measured with semi-structured interviews (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.