{"component": "definition", "props": {"groups": [{"size": 6, "samples": [{"hash": "2OSwruvAzHT", "uri": "/contracts/2OSwruvAzHT#trial-data", "label": "Clinical Trial Agreement", "score": 32.389849533, "published": true}, {"hash": "hdrEYJWTI8O", "uri": "/contracts/hdrEYJWTI8O#trial-data", "label": "Clinical Trial Agreement", "score": 31.7005414686, "published": true}, {"hash": "3Q2bLgVHfMv", "uri": "/contracts/3Q2bLgVHfMv#trial-data", "label": "Clinical Trial Agreement", "score": 25.8809034908, "published": true}], "snippet_links": [{"key": "without-limitation", "type": "clause", "offset": [15, 33]}, {"key": "research-data", "type": "clause", "offset": [35, 48]}, {"key": "data-records", "type": "clause", "offset": [91, 103]}, {"key": "other-documents-or-materials", "type": "clause", "offset": [120, 148]}, {"key": "the-trial", "type": "clause", "offset": [161, 170]}, {"key": "third-party-vendor", "type": "clause", "offset": [235, 253]}, {"key": "by-sponsor", "type": "clause", "offset": [265, 275]}, {"key": "types-of", "type": "clause", "offset": [306, 314]}], "snippet": "shall include, without limitation, Research Data, CRFs (or their equivalent) or electronic data records, as well as any other documents or materials created for the Trial and required to be submitted to Sponsor or the CRO or any other third party vendor instructed by Sponsor, such as X-ray, MRI, or other types of medical images, ECG, EEG, or other types of tracings or printouts, or data summaries.", "hash": "696cc91b9f3ac3337b721dee89ec7ccc", "id": 1}, {"size": 2, "samples": [{"hash": "35bVO5j6NXC", "uri": "/contracts/35bVO5j6NXC#trial-data", "label": "Clinical Trial Agreement", "score": 30.9340109091, "published": true}, {"hash": "5i42e7VsxFF", "uri": "/contracts/5i42e7VsxFF#trial-data", "label": "Clinical Trial Agreement", "score": 24.5201916496, "published": true}], "snippet_links": [{"key": "without-limitation", "type": "clause", "offset": [15, 33]}, {"key": "data-records", "type": "clause", "offset": [76, 88]}, {"key": "other-documents-or-materials", "type": "clause", "offset": [105, 133]}, {"key": "the-trial", "type": "clause", "offset": [146, 155]}, {"key": "third-party-vendor", "type": "clause", "offset": [220, 238]}, {"key": "by-sponsor", "type": "clause", "offset": [250, 260]}, {"key": "types-of", "type": "clause", "offset": [291, 299]}, {"key": "a-u", "type": "clause", "offset": [561, 564]}, {"key": "trial-subject", "type": "definition", "offset": [845, 858]}, {"key": "participating-in", "type": "definition", "offset": [881, 897]}, {"key": "subjekt-klinick\u00e9ho-hodnocen\u00ed", "type": "definition", "offset": [910, 938]}], "snippet": "shall include, without limitation, CRFs (or their equivalent) or electronic data records, as well as any other documents or materials created for the Trial and required to be submitted to Sponsor or the CRO or any other third party vendor instructed by Sponsor, such as X-ray, MRI, or other types of medical images, ECG, EEG, or other types of tracings or printouts, or data summaries. \u201eData klinick\u00e9ho hodnocen\u00ed\u201c zahrnuj\u00ed mimo jin\u00e9 CRF (\u010di jejich ekvivalent) nebo elektronick\u00e9 z\u00e1znamy dat, jako\u017e i ve\u0161ker\u00e9 dal\u0161\u00ed dokumenty \u010di materi\u00e1ly vytvo\u0159en\u00e9 pro hodnocen\u00ed, a u nich\u017e je po\u017eadov\u00e1no, aby byly p\u0159edlo\u017eeny zadavateli nebo CRO nebo jak\u00e9mukoli dodavateli t\u0159et\u00ed strany instruovan\u00fdm zadavatelem, jako jsou rentgenov\u00e9 sn\u00edmky, sn\u00edmky magnetick\u00e9 rezonance nebo jin\u00e9 typy l\u00e9ka\u0159sk\u00fdch sn\u00edmk\u016f, EKG, EEG \u010di jin\u00e9 typy sledov\u00e1n\u00ed \u010di v\u00fdtisk\u016f nebo souhrny dat. \u201cTrial Subject\u201d shall mean a patient participating in the Trial. \u201eSubjekt klinick\u00e9ho hodnocen\u00ed\u201c znamen\u00e1 pacienta \u00fa\u010dastn\u00edc\u00edho se klinick\u00e9ho hodnocen\u00ed.", "hash": "d954254db4ec489b9f9b4a28af293c96", "id": 2}, {"size": 2, "samples": [{"hash": "aHJwFxZk8v8", "uri": "/contracts/aHJwFxZk8v8#trial-data", "label": "License Agreement", "score": 33.0482178295, "published": true}, {"hash": "9Ef6kXTfh7i", "uri": "/contracts/9Ef6kXTfh7i#trial-data", "label": "License Agreement (Pharming Group N.V.)", "score": 31.8993839836, "published": true}], "snippet_links": [{"key": "clinical-trial-reports", "type": "clause", "offset": [34, 56]}, {"key": "ongoing-trial", "type": "definition", "offset": [122, 135]}, {"key": "by-or-on-behalf-of", "type": "definition", "offset": [159, 177]}, {"key": "to-the-extent", "type": "clause", "offset": [205, 218]}, {"key": "this-agreement", "type": "clause", "offset": [250, 264]}, {"key": "in-accordance-with", "type": "definition", "offset": [265, 283]}, {"key": "applicable-law", "type": "definition", "offset": [284, 298]}], "snippet": "means all data (together with all clinical trial reports and the results of analyses thereof) derived or generated in the Ongoing Trial or the Extension Study by or on behalf of Novartis or its Affiliate, to the extent transferable to Pharming under this Agreement in accordance with Applicable Law.", "hash": "d1439e91ba94fbf4db4e7da787fa54b0", "id": 3}, {"size": 2, "samples": [{"hash": "9RnfQxTBCOp", "uri": "/contracts/9RnfQxTBCOp#trial-data", "label": "Collaborative Research and Licensing Agreement", "score": 34.7980169309, "published": true}, {"hash": "jpMuMC0SnFt", "uri": "/contracts/jpMuMC0SnFt#trial-data", "label": "Collaborative Research and Licensing Agreement (Indevus Pharmaceuticals Inc)", "score": 21.0, "published": true}], "snippet_links": [{"key": "case-record", "type": "definition", "offset": [6, 17]}, {"key": "related-material", "type": "definition", "offset": [28, 44]}, {"key": "copies-of-correspondence", "type": "clause", "offset": [56, 80]}, {"key": "and-discharge", "type": "clause", "offset": [108, 121]}, {"key": "information-from", "type": "clause", "offset": [142, 158]}, {"key": "telephone-conversations", "type": "clause", "offset": [159, 182]}, {"key": "site-visits", "type": "definition", "offset": [187, 198]}, {"key": "individual-participants", "type": "clause", "offset": [203, 226]}, {"key": "laboratory-results", "type": "clause", "offset": [257, 275]}, {"key": "participating-in", "type": "definition", "offset": [307, 323]}, {"key": "phase-iii-clinical-trial", "type": "definition", "offset": [328, 352]}], "snippet": "means case record forms and related material (including copies of correspondence, hospital and clinic notes and discharge summaries, relevant information from telephone conversations and site visits) on individual participants received from the Centres and laboratory results obtained from the laboratories participating in the Phase III Clinical Trial. All such data will be anonymous;", "hash": "814e2fa88b891f7e8c5209a7aed0558d", "id": 4}, {"size": 2, "samples": [{"hash": "3JoNgFFqkxD", "uri": "/contracts/3JoNgFFqkxD#trial-data", "label": "Clinical Trial Agreement", "score": 22.1820670773, "published": true}], "snippet_links": [{"key": "clinical-data", "type": "definition", "offset": [27, 40]}, {"key": "with-respect-to", "type": "clause", "offset": [82, 97]}, {"key": "the-trial", "type": "clause", "offset": [98, 107]}, {"key": "case-report-forms", "type": "definition", "offset": [119, 136]}, {"key": "informed-consent-forms", "type": "clause", "offset": [160, 182]}, {"key": "principal-investigator", "type": "definition", "offset": [187, 209]}, {"key": "medical-records", "type": "definition", "offset": [260, 275]}], "snippet": "means all labora- tory and clinical data, primary and summary, that are generated with respect to the Trial, including case report forms, safety infor- mation, informed consent forms and Principal Investigator\u2019s study notebooks, excluding any original Subject medical records that are con-", "hash": "e33223c775f344b2bbdfa9e235f2df97", "id": 5}, {"size": 1, "samples": [{"hash": "2p7CoqIukdw", "uri": "/contracts/2p7CoqIukdw#trial-data", "label": "Clinical Trial Agreement", "score": 30.9723374371, "published": true}], "snippet_links": [{"key": "all-personal-data", "type": "definition", "offset": [6, 23]}, {"key": "relating-to", "type": "definition", "offset": [24, 35]}, {"key": "data-subject", "type": "definition", "offset": [40, 52]}, {"key": "by-provider", "type": "clause", "offset": [63, 74]}, {"key": "provider-representatives", "type": "clause", "offset": [78, 102]}, {"key": "processing-personal-data", "type": "definition", "offset": [154, 178]}, {"key": "on-behalf-of", "type": "clause", "offset": [179, 191]}, {"key": "the-controller", "type": "clause", "offset": [192, 206]}, {"key": "all-applicable-laws", "type": "clause", "offset": [355, 374]}, {"key": "as-amended", "type": "definition", "offset": [376, 386]}, {"key": "from-time-to-time", "type": "clause", "offset": [387, 404]}, {"key": "with-respect-to", "type": "clause", "offset": [406, 421]}, {"key": "the-processing", "type": "clause", "offset": [422, 436]}], "snippet": "means all personal data relating to any Data Subject collected by Provider or Provider Representatives or both. Provider and Provider Representatives are processing personal data on behalf of the controller which is Company and are therefore individually and collectively referred to as \"Processor\". Processor will comply, at their expense, with GDPR and all Applicable Laws, as amended from time to time, with respect to the Processing of Trial Data, and with the following provisions.", "hash": "8835d9496edcdd17c224248f510ca804", "id": 6}, {"size": 1, "samples": [{"hash": "3oGlzRFfGcL", "uri": "/contracts/3oGlzRFfGcL#trial-data", "label": "Clinical Trial Agreement", "score": 25.6406671125, "published": true}], "snippet_links": [{"key": "clinical-data", "type": "definition", "offset": [25, 38]}, {"key": "with-respect-to", "type": "clause", "offset": [80, 95]}, {"key": "the-trial", "type": "clause", "offset": [96, 105]}, {"key": "case-report-forms", "type": "definition", "offset": [117, 134]}, {"key": "safety-information", "type": "definition", "offset": [136, 154]}, {"key": "informed-consent-forms", "type": "clause", "offset": [156, 178]}, {"key": "principal-investigator", "type": "definition", "offset": [183, 205]}, {"key": "medical-records", "type": "definition", "offset": [258, 273]}, {"key": "good-clinical-practice", "type": "clause", "offset": [391, 413]}, {"key": "a-s", "type": "clause", "offset": [612, 615]}, {"key": "zdrojov\u00e9-dokumenty", "type": "clause", "offset": [1036, 1054]}], "snippet": "means all laboratory and clinical data, primary and summary, that are generated with respect to the Trial, including case report forms, safety information, informed consent forms and Principal Investigator\u2019s study note- books, excluding any original Subject medical records that are considered \u201cSource Docu- ments\u201d (as defined by International Conference on Harmonization (ICH) Guidance E6 \u201cGood Clinical Practice\u201d). Evropsk\u00e9 l\u00e9kov\u00e9 agentury a jej\u00edho p\u0159\u00edpadn\u00e9ho n\u00e1stupnick\u00e9ho org\u00e1nu (\u201eEMEA\u201c) a \u00da\u0159adu USA pro kontrolu potravin a l\u00e9\u010div a jeho p\u0159\u00edpadn\u00e9ho n\u00e1stupnick\u00e9ho org\u00e1nu (\u201eFDA\u201c) a v pln\u00e9m souladu s Protokolem a s Pr\u00e1vn\u00edmi p\u0159edpisy. \u201e\u00dadaje o klinick\u00e9m hodnocen\u00ed\u201c znamenaj\u00ed ve\u0161ker\u00e9 pr- votn\u00ed i souhrnn\u00e9 laboratorn\u00ed a klinick\u00e9 \u00fadaje vy- produkovan\u00e9 ve vztahu ke Klinick\u00e9mu hodnocen\u00ed, v\u010detn\u011b formul\u00e1\u0159\u016f l\u00e9ka\u0159sk\u00fdch z\u00e1znam\u016f o pacien- tech, bezpe\u010dnostn\u00edch informac\u00ed, formul\u00e1\u0159\u016f infor- movan\u00fdch souhlas\u016f a studijn\u00edch pozn\u00e1mek Hlav- n\u00edho zkou\u0161ej\u00edc\u00edho a s v\u00fdjimkou ve\u0161ker\u00fdch origin\u00e1- l\u016f zdravotn\u00edch z\u00e1znam\u016f Subjekt\u016f, kter\u00e9 jsou pova- \u017eov\u00e1ny za \u201eZdrojov\u00e9 dokumenty\u201c (dle definice Sm\u011brnice E6 Mezin\u00e1rodn\u00ed konference o harmoni- zaci (ICH) \u201eSpr\u00e1vn\u00e1 klinick\u00e1 praxe\u201c).", "hash": "ce2bf9218f3ebe6b33f87d28af25ed3c", "id": 7}, {"size": 1, "samples": [{"hash": "9qj3wBnhWJN", "uri": "/contracts/9qj3wBnhWJN#trial-data", "label": "Clinical Trial Agreement", "score": 26.0759753593, "published": true}], "snippet_links": [{"key": "without-limitation", "type": "clause", "offset": [15, 33]}, {"key": "data-records", "type": "clause", "offset": [76, 88]}, {"key": "other-documents-or-materials", "type": "clause", "offset": [105, 133]}, {"key": "the-trial", "type": "clause", "offset": [146, 155]}, {"key": "third-party-vendor", "type": "clause", "offset": [220, 238]}, {"key": "by-sponsor", "type": "clause", "offset": [250, 260]}, {"key": "types-of", "type": "clause", "offset": [291, 299]}, {"key": "a-u", "type": "clause", "offset": [561, 564]}], "snippet": "shall include, without limitation, CRFs (or their equivalent) or electronic data records, as well as any other documents or materials created for the Trial and required to be submitted to Sponsor or the CRO or any other third party vendor instructed by Sponsor, such as X-ray, MRI, or other types of medical images, ECG, EEG, or other types of tracings or printouts, or data summaries. \u201eData klinick\u00e9ho hodnocen\u00ed\u201c zahrnuj\u00ed mimo jin\u00e9 CRF (\u010di jejich ekvivalent) nebo elektronick\u00e9 z\u00e1znamy dat, jako\u017e i ve\u0161ker\u00e9 dal\u0161\u00ed dokumenty \u010di materi\u00e1ly vytvo\u0159en\u00e9 pro hodnocen\u00ed, a u nich\u017e je po\u017eadov\u00e1no, aby byly p\u0159edlo\u017eeny zadavateli nebo CRO nebo jak\u00e9mukoli dodavateli t\u0159et\u00ed strany instruovan\u00fdm zadavatelem, jako jsou rentgenov\u00e9 sn\u00edmky, sn\u00edmky magnetick\u00e9 rezonance nebo jin\u00e9 typy l\u00e9ka\u0159sk\u00fdch sn\u00edmk\u016f, EKG, EEG \u010di jin\u00e9 typy sledov\u00e1n\u00ed \u010di v\u00fdtisk\u016f nebo souhrny dat.", "hash": "03781e661eaf1f24c4c11c34a417ea2d", "id": 8}, {"size": 1, "samples": [{"hash": "a7AGUQ6WIMP", "uri": "/contracts/a7AGUQ6WIMP#trial-data", "label": "Data Sharing Agreement", "score": 33.5998908968, "published": true}], "snippet_links": [{"key": "data-sets", "type": "definition", "offset": [20, 29]}, {"key": "patient-data", "type": "clause", "offset": [45, 57]}, {"key": "case-report-forms", "type": "definition", "offset": [87, 104]}, {"key": "data-queries", "type": "clause", "offset": [109, 121]}], "snippet": "means the formatted data sets containing the patient data reported by Investigators on case report forms and data queries\".", "hash": "4b5c0f6e9a2d2983c83138ae5272abe3", "id": 9}, {"size": 1, "samples": [{"hash": "90YovujkiAC", "uri": "/contracts/90YovujkiAC#trial-data", "label": "Clinical Trial Agreement", "score": 31.456894255, "published": true}], "snippet_links": [{"key": "without-limitation", "type": "clause", "offset": [15, 33]}, {"key": "research-data", "type": "clause", "offset": [35, 48]}, {"key": "data-records", "type": "clause", "offset": [91, 103]}, {"key": "other-documents-or-materials", "type": "clause", "offset": [120, 148]}, {"key": "the-trial", "type": "clause", "offset": [161, 170]}, {"key": "third-party-vendor", "type": "clause", "offset": [235, 253]}, {"key": "by-sponsor", "type": "clause", "offset": [265, 275]}, {"key": "types-of", "type": "clause", "offset": [306, 314]}, {"key": "trial-subject", "type": "definition", "offset": [407, 420]}, {"key": "participating-in", "type": "definition", "offset": [443, 459]}, {"key": "investigators-and-research-staff", "type": "clause", "offset": [481, 513]}, {"key": "an-employee", "type": "definition", "offset": [524, 535]}, {"key": "responsible-for", "type": "clause", "offset": [564, 579]}, {"key": "in-accordance-with", "type": "definition", "offset": [607, 625]}, {"key": "applicable-law", "type": "definition", "offset": [626, 640]}, {"key": "the-protocol", "type": "clause", "offset": [642, 654]}, {"key": "applicable-policies", "type": "clause", "offset": [711, 730]}, {"key": "any-other-person", "type": "definition", "offset": [760, 776]}, {"key": "prior-written-approval", "type": "definition", "offset": [801, 823]}, {"key": "written-statement", "type": "clause", "offset": [868, 885]}, {"key": "other-interests", "type": "definition", "offset": [921, 936]}, {"key": "in-connection-with", "type": "clause", "offset": [937, 955]}, {"key": "the-performance", "type": "clause", "offset": [956, 971]}, {"key": "financial-disclosure", "type": "definition", "offset": [1009, 1029]}, {"key": "upon-the-effective-date", "type": "clause", "offset": [1031, 1054]}, {"key": "this-agreement", "type": "clause", "offset": [1109, 1123]}, {"key": "the-sponsor", "type": "clause", "offset": [1166, 1177]}, {"key": "in-writing", "type": "definition", "offset": [1178, 1188]}, {"key": "not-available", "type": "definition", "offset": [1236, 1249]}, {"key": "agreement-may-be-terminated", "type": "clause", "offset": [1256, 1283]}], "snippet": "shall include, without limitation, Research Data, CRFs (or their equivalent) or electronic data records, as well as any other documents or materials created for the Trial and required to be submitted to Sponsor or the CRO or any other third party vendor instructed by Sponsor, such as X-ray, MRI, or other types of medical images, ECG, EEG, or other types of tracings or printouts, or data summaries. 1.22 \u201cTrial Subject\u201d shall mean a patient participating in the Trial. 2 PI, Sub-Investigators and Research Staff 2.1 PI is an employee of Institution and shall be responsible for the direction of the Trial in accordance with Applicable Law, the Protocol, Sponsor\u2019s instructions, IEC approval and Institution\u2019s applicable policies. Institution may not appoint any other person as PI without Sponsor\u2019s prior written approval. PI shall provide Sponsor and/or CRO with a written statement about his/her possible economic or other interests in connection with the performance of the Trial and Trial preparations (financial disclosure) upon the Effective Date. If PI is unable to perform the duties required under this Agreement, Institution and PI shall promptly notify the Sponsor in writing. If a replacement acceptable to the Sponsor is not available, this Agreement may be terminated as provided in Section 20.1.e) of this Agreement. 1.18 \u201eProdukt Zad\u00e1vate\u013ea\u201c znamen\u00e1 produkt Zad\u00e1vate\u013ea, ktor\u00fd sa v Sk\u00fa\u0161an\u00ed sk\u00fama. Ak sa Produkt Zad\u00e1vate\u013ea sk\u00fama v Sk\u00fa\u0161an\u00ed v kombin\u00e1cii s in\u00fdm produktom, \u201eProdukt zad\u00e1vate\u013ea\u201c znamen\u00e1 ich kombin\u00e1ciu. 1.19 \u201eOd\u0161kodnen\u00e9 osoby Zad\u00e1vate\u013ea\u201d maj\u00fa v\u00fdznam, ak\u00fd sa uv\u00e1dza v \u010cl\u00e1nku 19.1. 1.20 \u201eSk\u00fa\u0161anie\u201d znamen\u00e1 multicentrick\u00e9 klinick\u00e9 sk\u00fa\u0161anie, ktor\u00e9 sa m\u00e1 realizova\u0165 v s\u00falade s Protokolom.", "hash": "cad43a5cedd03367a20b17ad593002b8", "id": 10}], "next_curs": "ClcSUWoVc35sYXdpbnNpZGVyY29udHJhY3RzcjMLEhpEZWZpbml0aW9uU25pcHBldEdyb3VwX3Y1NiITdHJpYWwtZGF0YSMwMDAwMDAwYQyiAQJlbhgAIAA=", "definition": {"size": 24, "title": "Trial Data", "snippet": "shall include, without limitation, Research Data, CRFs (or their equivalent) or electronic data records, as well as any other documents or materials created for the Trial and required to be submitted to Sponsor or the CRO or any other third party vendor instructed by Sponsor, such as X-ray, MRI, or other types of medical images, ECG, EEG, or other types of tracings or printouts, or data summaries.", "id": "trial-data", "examples": ["Medical records relating to Trial Subjects that are not submitted to Sponsor may include some of the same information as is included in <strong>Trial Data</strong>; however, Sponsor makes no claim of ownership to those documents or the information they contain.", "Institution and/or Principal Investigator will promptly resolve any discrepancies that are identified between the <strong>Trial Data</strong> and the Trial Subject\u2019s medical records.", "Permitted uses and disclosures of <strong>Trial Data</strong> are described in Section 15 (Publications) of this Agreement.", "Institution and Principal Investigator will ensure accurate and timely collection, recording, and submission of <strong>Trial Data</strong>.", "For Confidential Information other than <strong>Trial Data</strong> (hereinafter defined) and Biological Samples (hereinafter defined) analysis data, these obligations of nonuse and nondisclosure survive termination of this Agreement and continue for a period of five (5) years after termination.", "Subject to Institution\u2019s and/or Principal Investigator\u2019s right to publish any <strong>Trial Data</strong> and the non-exclusive license that permits certain uses, Sponsor is the exclusive owner of all <strong>Trial Data</strong>.", "Sample Data will be treated as <strong>Trial Data</strong>; therefore, if Sponsor provides Sample Data to the Institution or Principal Investigator, that data will be subject to the permitted use of <strong>Trial Data</strong> as outlined in this Agreement.", "Sponsor grants Institution and Principal Investigator a royalty free non-exclusive license, with no right to sublicense, to use <strong>Trial Data</strong> for internal research or educational purposes.", "Institution will promptly resolve any discrepancies that are identified between the <strong>Trial Data</strong> and the Trial Subject\u2019s medical records.", "Institution will ensure accurate and timely collection, recording, and submission of <strong>Trial Data</strong>."], "related": [["historical-data", "Historical data", "Historical data"], ["confidential-data", "Confidential Data", "Confidential Data"], ["unicef-data", "UNICEF Data", "UNICEF Data"], ["clinical-data", "Clinical Data", "Clinical Data"], ["technical-data", "Technical Data", "Technical Data"]], "related_snippets": [], "updated": "2025-07-06T21:56:50+00:00"}, "json": true, "cursor": ""}}