MRI data processing and management
Management of the data collected at the MRI Lab is based on the guidelines described in the CIMeC General Data Protection Regulation, which applies Regulation (EU) 2016/679 “General Data Protection Regulation” (hereinafter “GDPR”), to scientific research. The two essential points to be considered in data management are:
1) For any research project, responsibility for the data processing procedure is assigned to the project PI; it is therefore essential that the PI, together with collaborators, define data processing right from the preparatory phase of the research project;
2) Personal data processing is subject to severe privacy protection restrictions, violation of which entails legal risks for both the PI and CIMeC. Luckily, pseudonymisation and anonymisation make it possible to manage data far more freely. It is therefore best to apply the provisions of the GDPR, which require the pseudonymisation/anonymisation of data as quickly as possible along the processing chain.
For a description of the procedure necessary to define data processing by the PI and for the general CIMeC data-processing guidelines, refer to the CIMeC Data Protection Regulation.
Data collected and processed by the MRI Lab
MRI Data: the MRI Lab acquires MRI images that are then made available to the researcher via the CIMeC Data Retrieving System (CDRMS).
The MRI images may come in three different formats:
Non-anonymous MRI images:
Non-anonymous images are images on CIMeC servers, where the data collected about the participant is stored together with name, surname and date of birth. This data, which is collected in this way because of the way the laboratory is constructed and to ensure the success of trials, can be accessed only by the MRI Lab staff, as well as – exclusively in order to maintain the system – CIMeC system administrators. The data is stored in non-anonymous form on the LNiF servers for 10 years from the date of acquisition (Ministerial Decree of 14/02/1997) and, redundantly, on another server at the University of Trento, in another building away from the LNiF, with access limited to the administrators of the LNiF computer system. This data cannot be accessed by researchers.
Pseudonymised MRI images for project purposes:
Pseudonymised data with no reference whatsoever to name and surname is available to project members. The conservation and availability of the pseudonymised images is guaranteed to involved researchers for up to a year after the project has ended.
Reconciliation file: document associating the pseudonymisation code (and therefore the data collected) with the contact and personal data of the participant. This file cannot be accessed by researchers.
Behavioural data: various types of data resulting from the trial scripts of the experiment. The contents of this data vary from experiment to experiment, depending on the needs of each project as outlined during the experimental-design and project-approval phases. It is strongly recommended that they not contain any participant-identifying data, other than the pseudonym code, should reconciliation be necessary. This data is stored on the MRI Lab stimulation PC only for as long as necessary for registration. Once the data is obtained, the researcher is responsible for transferring it to a suitable computer storage device, preferably the CIMEC share.
Medical history data: Data relating to medical history, collected to ensure the compatibility of the subject with MRI registration (both on paper and in electronic format), will be kept for 5 years (Ministerial Decree of 14/01/2021) and will only be available to MRI Lab staff, the staff member responsible for storing the referenced data, and – for system maintenance only – CIMeC system administrators. This data cannot be accessed by researchers.
Radiologist Report: The report prepared by the Radiologist from acquired images will be stored for an unlimited time (Ministerial Decree of 14/02/1997) and will be available only to MRI Lab staff, the staff member responsible for storing the referenced data, and – for system maintenance only – CIMeC system administrators. This report cannot be accessed by researchers.
Data processing procedure.
Researchers must adhere to the following directions:
- The researcher has access to the MRI Lab stimulation computer to upload and test stimulation scripts. It is strictly prohibited to transfer any personal data of trial subjects to the stimulation computer.
- MRI data is made available to the researcher via the CIMeC Data Retrieval System (CDRMS), which has the following characteristics:
- Immediacy: The MRI data is normally made available to the user within 24 hours of acquisition, no matter what day of the week the experiment is performed.
- Portability: The MRI data is supplied pseudonymised, in a standard format used for biomedical-type image acquisitions (Digital Imaging and COmmunications in Medicine, DICOM). In addition to the data in DICOM format, the data can also be obtained in NIfTI (Neuroimaging Informatic Technology Initiative) format, automatically, during download. It is strictly prohibited to save any information on the data downloaded that may allow tracing the identity of the subject.
- Availability: the user can only download from the system that data acquired in projects in which the user is involved. The data will be available for downloading for at least 1 year after acquisition. If the system should signal that data is unavailable, the user should contact the IT office for assistance. If a project is closed, the data will still be available for 1 year after the date of closure.
- If collected, behavioural data is saved to the stimulation PC, which, for technical reasons, is not connected to the network. At the end of the trial session, these files must be copied and deleted from the stimulation PC. They can be copied using a password-protected pen drive, taking care to delete the data once transferred to the CIMEC share. CIMeC refuses any and all liability for the storage of data saved to the laboratory computers. At the end of the trial, all data and scripts used for the project on the stimulation PC can be deleted without notifying the Facility staff.
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