Guidance Radiology Data Request Form

1. Title research project

Please enter the title of your project as stated on the non WMO statement submitted to the METC.

2. Accept Data sharing policy Imaging department

The “Data sharing policy en aanvraagformulier retrospectief onderzoek afdeling Beeldvorming” can be found in ODIN 056645.

3. Confirm type of data request: retrospective (available in database of Imaging/Radiology)

This application procedure is only intended for retrospective research: imaging data have already been collected and are in principle available from radiology/imaging.

This form is not suitable for the request of prospective research! If you have questions you can contact the Imaging department via this link.

4. Do you know the accession numbers of the cohort you are looking for?

5. In case of external applicant: approval research partner Imaging department

Internal researchers refers to employees that are primarily employed at “Imaging” department of Maastricht UMC+.

External researchers refers to researchers employed at departments within the Maastricht UMC+ other than Imaging, and to (healthcare) institutions/UMCs other than Maastricht UMC+.

If one wishes to use imaging data produced within the Imaging department of Maastricht UMC+, external researchers must complete the following prior to the study:

Approach the intended research partner(s) within the Imaging department (physician or non-clinical scientific employee) prior to the start of the project for approval, as well as asking him/her to participate in developing the study plan, carrying out the research and writing the resulting publication(s).

7. In case of external use: approval head of Imaging department

Internal refers to research that is limited to Maastricht UMC+. External use means outside Maastricht UMC+ (international / multicenter / etc.)

If external use you need approval from the head of the department (or representative).

Also applicable for independent data approach for VNA research.

8. Approval METC azM/UM research not subjected to WMO (for retrospective research)

Retrospective Medical Research: not subjected to WMO

In principal, retrospective medical research (for which this data request procedure is intended) is not subject to the WMO. However, the Board of Directors of the MUMC+ has determined that all medical scientific research proposals not subject to the WMO should be assessed by the Medical Ethics Review Committee azM/UM (METC azM/UM) for approval.

In order to get this approval the researcher has to send in an application form to the METC azM/UM digitally via → Apply for non-WMO approval from METC azM/UM (only available in Dutch). In case the application has been approved, the METC azM/UM documents this decision issuing a non-WMO statement. See for more information and contact details on this procedure the METC azM/UM website: https://metc.mumc.nl/niet-wmo-plichtig-onderzoek (only available in Dutch).

Medical research subjected to WMO

The researcher initially determines whether or not the respective research is subject to the Medical Research Involving Human Subjects Act (WMO) or not on the basis of a set of criteria.

Research is subject to the WMO if the following criteria are met:

1. It concerns medical scientific research and

2. Participants are subject to procedures or are required to follow rules of behaviour.

Interpretation of these criteria is described on the website of the Central Committee on Research Involving Human Subjects (CCMO) → Your research: Is it subject to the WMO or not?

A medical research project within UM/MUMC+ that is subjected to the WMO may only be carried out if the METC azM/UM has assessed this research positively. For information on the approval procedure and contact details regarding research subjected to WMO, see the METC azM/UM website for details → Primary Submission (research subjected to WMO)

9. Approval Board of Directors

All human-related scientific research proposals in the MUMC+ must be approved by the Board of Directors of the MUMC+ (azM and UM FHML) before the research can start.

On behalf of the Executive Board, the CTCM coordinates the central registration and results of several assessments. Some of the assessments are carried out by the CTCM itself.

https://www.ctcm.nl/nl/onze-diensten/approval-procedure-assistance/

CTCM will receive the non WMO statement of the METC and will check if additional approvals are necessary (for example check on instrumental service).
If all necessary approvals are in place, CTCM will prepare the approval letter and have the letter send to the Board of Directors for signature.

10. In case of need for Data Transfer Agreement (DTA) / Data Sharing Agreement (DSA): supply document

Whether or not a a medical research project within the MUMC+ needs a Data Transfer Agreement (DTA) or Data Sharing Agreement (DSA) or alike always needs to be assessed by an expert from the Clinical Trial Center Maastricht (CTCM), broadly by answering the below set of questions (which can give the researcher already an indication of the result of this assessment on forehand):

Does the research project entail

1. collaboration with external parties (outside MUMC+) that need access to the collected research data;

2. the use of external research tools (hosted outside MUMC+) to which data has to be uploaded;

3. analyzing data in an external laboratory or comparable facility (outside MUMC+);

4. the use of research data from external parties (outside MUMC+);

5. the use of medical devices that register data?

The assessment procedure by the CTCM will be initiated automatically via the METC azM/UM when a non-WMO statement has been issued by the committee. The procedure will be executed in close coordination with the applying researcher. In case the assessment is positive, CTCM also takes care of drafting up the specific agreement itself for the project (mostly one of the standard templates suffice). See for more information and contact details the CTCM website on approval procedures → https://www.ctcm.nl/nl/onze-diensten/approval-procedure-assistance/

12. Principal Investigator

Please enter the prinicpal investigator of your project as stated on the non WMO statement submitted to the METC.

13. Affiliation

Please select in the dropdown list your department in case you are affiliated with UM/MUMC+. In case you are an external researcher (affiliation outside UM/MUMC+), please select other and fill out the name of your institute and/or department.

15. Abstract of proposal

Please enter the abstract of your proposal.

16. Plan of action

Please describe the purpose why you intend to use the retrospective radiology data and elaborate on the why you want to use these data.

17. Involved parties, persons and roles

Please elaborate on the involved parties, persons and roles which will collaborate on your project and who will use the data.

18. Please specify the parameters of the search you would like to request

Please describe the type of data you intend to you in your research.
If possible, please define the type of data (CT, MRI, …), the start and stop date of collection, demographics of collected data, … .

19. How many records do you want to obtain?

Please give an estimation on the amount of records you need in order to perform perform your analysis of the data.

20. Have you filled in all questions truthfully?

By sending the request, you confirm all questions have been filled in truthfully and in correspondence to all law and privacy guidelines.