P12_Exhibit_1_UL_DISH-8_COVIRNA_01_MS_29.10.2020_CK.json 14.8 KB
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[
    {
        "source": "P12_Exhibit_1_UL_DISH-8_COVIRNA_01_MS_29.10.2020_CK.xlsx",
        "contacts": [
            {
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                "first_name": "John.",
                "last_name": "Doe.",
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                "role": "Principal_Investigator",
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                "email": "john.doe@imise.uni-leipzig.de",
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                "affiliations": [
                    "Universit\u00e4t Leipzig"
                ]
            },
            {
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                "first_name": "Jane",
                "last_name": "Doe",
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                "role": "Legal_Representative",
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                "email": "jane.doe@imise.uni-leipzig.de",
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                "affiliations": [
                    "Universit\u00e4t Leipzig"
                ]
            },
            {
                "first_name": "Ronal",
                "last_name": "SPEER",
                "role": "Data_Protection_Officer",
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                "email": "alice.white@imise.uni-leipzig.de",
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                "affiliations": [
                    "Universit\u00e4t Leipzig"
                ]
            }
        ],
        "data_declarations": [
            {
                "title": "PROVID-PROGRESS",
                "source_study": "PROVID cohort of hospitalized COVID-19 patients",
                "data_types": [
                    "Clinical_data",
                    "Lifestyle_data",
                    "Other_Phenotype_data",
                    "Other",
                    "Samples"
                ],
                "data_type_notes": "Data from laboratory measurements concerning health, Biomaterials including PAXgene for RNA extraction  Notes on samples: PAXgene blood",
                "de_identification": "pseudonymized",
                "consent_status": "heterogeneous",
                "consent_status_description": "n/a",
                "subject_categories": "cases",
                "has_special_subjects": true,
                "special_subject_notes": "Individuals not able to consent at the time of enrolment due to their health status. Consent will be obtained from legal representative.",
                "storage_end_date": "2035-12-31",
                "use_restrictions": [
                    {
                        "use_class": "RS[XX]",
                        "use_restriction_rule": "CONSTRAINTS",
                        "use_class_note": "Research on airway infections, their treatment and consequences"
                    },
                    {
                        "use_class": "GS[XX]",
                        "use_restriction_rule": "CONSTRAINTS",
                        "use_class_note": "Patients can individually decide if they want to allow data sharing to parties not covered by the European GDPR. If consented to by the patient, the third party will have to be bound by contract to the standards layed out in the GDPR"
                    },
                    {
                        "use_class": "IS",
                        "use_restriction_rule": "CONSTRAINTS",
                        "use_class_note": "Have to follow research goals regarding airway infections, their treatment and consequences"
                    },
                    {
                        "use_class": "TS-[XX]",
                        "use_restriction_rule": "CONSTRAINTS",
                        "use_class_note": "Data have to be deleted after 15 years except if required to be stored for reasons of reproducable research or ongoing new add-on studies the patient consented to"
                    },
                    {
                        "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": "2035-12-31"
                    },
                    {
                        "use_class": "PUB",
                        "use_restriction_rule": "CONSTRAINTS",
                        "use_class_note": "The cohort study must be cited. Authors from the cohort project have to be considered according to their contribution."
                    },
                    {
                        "use_class": "IP",
                        "use_restriction_rule": "CONSTRAINTS",
                        "use_class_note": "See COVIRNA consortium agreement"
                    }
                ],
                "access_procedure": "Research goal, background, planned analyses and planned publication need to be stated. Adherance to GDPR regulations must be confirmed. DAC will decide on adherance to informed consent and competing interests. ",
                "access_category": "controlled-access"
            },
            {
                "title": "PROVID-CAPNETZ",
                "source_study": "PROVID cohort of hospitalized COVID-19 patients",
                "data_types": [
                    "Clinical_data",
                    "Samples"
                ],
                "data_type_notes": "Data from laboratory measurements concerning health, Biomaterials including PAXgene for RNA extraction  Notes on samples: PAXgene blood",
                "de_identification": "pseudonymized",
                "consent_status": "heterogeneous",
                "consent_status_description": "n/a",
                "subject_categories": "cases",
                "has_special_subjects": true,
                "special_subject_notes": "Individuals not able to consent at the time of enrolment due to their health status. Consent will be obtained from legal representative.",
                "storage_end_date": "2035-12-31",
                "use_restrictions": [
                    {
                        "use_class": "RS[XX]",
                        "use_restriction_rule": "CONSTRAINTS",
                        "use_class_note": "Research on airwy infections, their treatment and consequences"
                    },
                    {
                        "use_class": "GS[XX]",
                        "use_restriction_rule": "CONSTRAINTS",
                        "use_class_note": "Patients can individually decide if they want to allow data sharing to parties not covered by the European GDPR. If consented to by the patient, the third party will have to be bound by contract to the standards layed out in the GDPR"
                    },
                    {
                        "use_class": "IS",
                        "use_restriction_rule": "CONSTRAINTS",
                        "use_class_note": "Have to follow research goals regarding airway infections, their treatment and consequences"
                    },
                    {
                        "use_class": "TS-[XX]",
                        "use_restriction_rule": "CONSTRAINTS",
                        "use_class_note": "Data have to be deleted after 15 years except if required to be stored for reasons of reproducable research or ongoing new add-on studies the patient consented to"
                    },
                    {
                        "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": "2035-12-31"
                    },
                    {
                        "use_class": "PUB",
                        "use_restriction_rule": "CONSTRAINTS",
                        "use_class_note": "The cohort study must be cited. Authors from the cohort project have to be considered according to their contribution."
                    },
                    {
                        "use_class": "IP",
                        "use_restriction_rule": "CONSTRAINTS",
                        "use_class_note": "See COVIRNA consortium agreement"
                    }
                ],
                "access_procedure": "Research goal, background, planned analyses and planned publication need to be stated. Adherance to GDPR regulations must be confirmed. DAC will decide on adherance to informed consent. ",
                "access_category": "controlled-access"
            }
        ],
        "studies": [
            {
                "name": "PROVID-PROGRESS",
                "description": "The PROVID-PROGRESS Study is a prospective, longitudinal, observational, multi-center study of hospitalized Patients positive for SARS-CoV-2 with the aim to identify clinical and molecular markers of disease progression and new therapies. U07.1! , COVID-19, SARS-CoV-2 infection, prospective, longitudinal, observational, multi-center, medical history, clinical characteristics, laboratory parameters, quality of life, mechanical ventilation, medication, treatments",
                "has_ethics_approval": false,
                "ethics_approval_notes": "see Remarks",
                "url": "https://www.gesundheitsforschung-bmbf.de/de/provid-klinische-molekulare-und-funktionelle-biomarker-fur-prognose-pathomechanismen-und-11690.php",
                "contacts": [
                    {
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                        "first_name": "Jim",
                        "last_name": "Doe",
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                        "role": "Principal_Investigator",
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                        "email": "jim.doe@charite.de",
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                        "affiliations": [
                            "Charit\u00e9 - Universit\u00e4tsmedizin Berlin"
                        ]
                    }
                ]
            },
            {
                "name": "PROVID-CAPNETZ",
                "description": "The PROVID-CAPNETZ Study is a prospective, longitudinal, observational, multi-center study of hospitalized Patients positive for SARS-CoV-2 with the aim to identify clinical and molecular markers of disease progression and new therapies. U07.1! , COVID-19, SARS-CoV-2 infection, prospective, longitudinal, observational, multi-center, medical history, clinical characteristics, laboratory parameters, quality of life, mechanical ventilation, medication, treatments",
                "has_ethics_approval": true,
                "ethics_approval_notes": "301-2008",
                "url": "https://www.gesundheitsforschung-bmbf.de/de/provid-klinische-molekulare-und-funktionelle-biomarker-fur-prognose-pathomechanismen-und-11690.php",
                "contacts": [
                    {
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                        "first_name": "Jack",
                        "last_name": "Black",
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                        "role": "Other",
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                        "email": "jack.black@mh-hannover.de",
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                        "affiliations": [
                            "MHH Hannover"
                        ]
                    }
                ]
            }
        ],
        "legal_bases": [
            {
                "data_declarations": [
                    "PROVID-PROGRESS"
                ],
                "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": [
                    "PROVID-PROGRESS"
                ],
                "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": [
                    "PROVID-PROGRESS"
                ],
                "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": [
                    "PROVID-PROGRESS"
                ],
                "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?*"
            },
            {
                "data_declarations": [
                    "PROVID-CAPNETZ"
                ],
                "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": [
                    "PROVID-CAPNETZ"
                ],
                "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": [
                    "PROVID-CAPNETZ"
                ],
                "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": [
                    "PROVID-CAPNETZ"
                ],
                "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": "PROVID_2020_01",
        "project": "COVIRNA"
    }
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]