Submission of research projects not involving humans and promotion within the CRMR MaRDi reference centres
Type of studies:
Studies not involving human subjects (i.e. without active participation of the patient) outside the scope of the Jardé law. Usually these are studies on the reuse of medical data (retrospective studies of files).
- Registration of the research project in the public directory of the INDS, after verification that the study complies with the reference methodology MR-004 to which MaRDi subscribes. If the project does not comply with the MR-004 reference methodology (patient information impossible, genetic research aimed at identifying or re-identifying the person, matching of existing data for the same individual from several centres etc.), the project will be discussed again with the principal investigator.
- Registration of the project on the MaRDi processing register (compliance with the GDPR).
- Distribution of the project to all MaRDi centres to ensure publicity.
Responsibilities of the principal investigator:
- Design of the project.
- Presentation to an ethics committee (necessary to obtain an ethical opinion on the project and often to publish). The ethics committee can be a local ethics committee or that of the GFHGNP (https://www.gfhgnp.org/recherches-et-formations/comite-dethique/).
- Creation of an e-CRF.
- Statistical analyses.
- Writing the article, which must follow the MaRDi publication charter.
However, help can also be provided on these questions, on a case-by-case basis, after discussion with the coordinator and the project manager.
The standard documents necessary for submission of the project are:
1) Request for a collaborative study which will be used to inform the MaRDi centres.
2) Documents submitted by the principal investigator to the ethics committee and which usually include:
- The study protocol
- The study summary
- The information and no-objection note
- The CRF
These documents are available in this area of the MaRDi website.
The documents should be sent by email to the MaRDi project manager:
Naim DRID firstname.lastname@example.org
In any case, Naim DRID can assist you in putting together your files. Do not hesitate to contact him with any questions you may have.