P1_LIH_Exhibit_1_UL_DISH-8_COVIRNA.json 8.11 KB
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[
    {
        "source": "P1_LIH_Exhibit_1_UL_DISH-8_COVIRNA.xlsx",
        "contacts": [
            {
                "first_name": "Yvan",
                "last_name": "DEVAUX",
                "role": "Researcher",
                "email": "yvan.devaux@lih.lu ",
                "affiliations": [
                    "Luxembourg Institute of Health"
                ]
            },
            {
                "first_name": "Ulf",
                "last_name": "NEHRBASS",
                "role": "Legal_Representative",
                "email": "yvan.devaux@lih.lu ",
                "affiliations": [
                    "Luxembourg Institute of Health"
                ]
            },
            {
                "first_name": "Laurent",
                "last_name": "Pr\u00e9votat",
                "role": "Data_Protection_Officer",
                "email": "yvan.devaux@lih.lu ",
                "affiliations": [
                    "Luxembourg Institute of Health"
                ]
            },
            {
                "first_name": "Laurent",
                "last_name": "Pr\u00e9votat",
                "role": "Other",
                "email": "yvan.devaux@lih.lu ",
                "affiliations": [
                    "Luxembourg Institute of Health"
                ]
            }
        ],
        "data_declarations": [
            {
                "title": "PREDI-COVID participants` samples and data for COVIRNA",
                "source_study": "PREDI-COVID  ",
                "data_types": [
                    "Clinical_data",
                    "Other",
                    "Samples"
                ],
                "data_type_notes": "Clinical data (ISARIC protocol CRF data), baseline and follow-up data  Notes on samples: From each predi-COVID participant: 1 aliquot of 400microL EDTA-plasma and 1 whole blood sample collected in PAXgene tube",
                "de_identification": "pseudonymized",
                "consent_status": "heterogeneous",
                "consent_status_description": "Specific agreement is sought on the use of clinical data and data collected through the CoLive digital application.\nClinical data is dissociated from sample collection. Specific agreement is sough on the sample and/or data collection by research areas (virology and/or other health domain research), sharing with non-EU countries, secondary use of samples and incidental findings.",
                "subject_categories": "cases",
                "has_special_subjects": true,
                "special_subject_notes": "In exceptional cases, when the subject is presented with acute conditions and unable to receive and understand the information about the study, the Informed consent can be first requested from the next relative and from the subject as soon as this becomes possible.",
                "storage_end_date": "",
                "use_restrictions": [
                    {
                        "use_class": "RS[XX]",
                        "use_restriction_rule": "CONSTRAINTS",
                        "use_class_note": "biomedical research"
                    },
                    {
                        "use_class": "GS[XX]",
                        "use_restriction_rule": "CONSTRAINTS",
                        "use_class_note": "In the ICF, the participant is asked to agree/or not on the transfer of samples in non-EU countries. Only participant who have answered \"yes\" will be included. "
                    },
                    {
                        "use_class": "IS",
                        "use_restriction_rule": "NO_CONSTRAINTS",
                        "use_class_note": "\u2026"
                    },
                    {
                        "use_class": "TS-[XX]",
                        "use_restriction_rule": "CONSTRAINTS",
                        "use_class_note": "Encoded data will be kept for 15 years after the end of the study. However, 5 years after the end of the study, nominative data and the correspondence table between the identifying data and the study number will be deleted."
                    },
                    {
                        "use_class": "PS",
                        "use_restriction_rule": "CONSTRAINTS",
                        "use_class_note": "Use of DATA is limited to the RESEARCH PROJECT.\nIs the use of data limited to the project named in the Submission sheet? PROJECT: COVIRNA"
                    },
                    {
                        "use_class": "TS-[XX]",
                        "use_restriction_rule": "CONSTRAINTS",
                        "use_class_note": ""
                    },
                    {
                        "use_class": "PUB",
                        "use_restriction_rule": "CONSTRAINTS",
                        "use_class_note": "The Predi-COVID study team will be acknowledged in all communications."
                    },
                    {
                        "use_class": "IP",
                        "use_restriction_rule": "NO_CONSTRAINTS",
                        "use_class_note": "\u2026."
                    }
                ],
                "access_procedure": "Described in the DSA",
                "access_category": "controlled-access"
            }
        ],
        "studies": [
            {
                "name": "PREDI-COVID",
                "description": "Luxembourg cohort of positive patients for COVID-19: a stratification study to predict patient prognosis The study aims at identifying factors associated with the COVID-19 disease severity. COVID-19 patients with severity criteria will be compared to patients with mild disease managed at home.\nA deep phenotyping related to the symptoms of the disease as well as biosampling allowing for laboratory-based and computational analytics will be performed.",
                "has_ethics_approval": true,
                "ethics_approval_notes": "202003/07",
                "url": "https://researchluxembourg.lu/covid-19-taskforce/predi-covid/",
                "contacts": null
            }
        ],
        "legal_bases": [
            {
                "data_declarations": [
                    "PREDI-COVID participants` samples and data for COVIRNA"
                ],
                "personal_data_codes": [
                    "Standard"
                ],
                "legal_basis_codes": [
                    "6.1(a)"
                ],
                "legal_basis_notes": "What is the legal basis according to Art. 6.1 GDPR for the collection of standard (non-sensitive) personal data?*"
            },
            {
                "data_declarations": [
                    "PREDI-COVID participants` samples and data for COVIRNA"
                ],
                "personal_data_codes": [
                    "Standard"
                ],
                "legal_basis_codes": [
                    "6.1(a)"
                ],
                "legal_basis_notes": "What is the legal basis according to Art. 6.1 GDPR for the sharing and, where applicable, the subsequent processing of standard (non-sensitive)  personal data?*"
            },
            {
                "data_declarations": [
                    "PREDI-COVID participants` samples and data for COVIRNA"
                ],
                "personal_data_codes": [
                    "Special"
                ],
                "legal_basis_codes": [
                    "6.1(a)"
                ],
                "legal_basis_notes": "What is the legal basis according to Art. 6.1 GDPR  for the collection of special category (sensitive) personal data?*"
            },
            {
                "data_declarations": [
                    "PREDI-COVID participants` samples and data for COVIRNA"
                ],
                "personal_data_codes": [
                    "Special"
                ],
                "legal_basis_codes": [
                    "6.1(a)"
                ],
                "legal_basis_notes": "What is the legal basis according to Art. 6.1 GDPR  for the  sharing and, where applicable, subsequent processing of special category (sensitive) personal data?*"
            }
        ],
        "name": "LIH Data Information for COVIRNA",
        "project": "COVIRNA"
    }
]