{"component": "clause", "props": {"groups": [{"snippet": "For each Study, the Institution and the applicable Principal Investigator acknowledge and agree that the data collected during the Study (\u201cStudy Data\u201d), except as otherwise provided in Section 15.8, is owned by SPONSOR. SPONSOR may use all Study Data collected during the Study for any and all purposes at the sole discretion of SPONSOR, provided it is consistent with Applicable Laws and regulations, this Agreement and the informed consent form signed by the Subject. Study Data is confidential, and Institution agrees that premature disclosures of the data may be misleading. If the Study is a Multi-Center Study, then after the completion, or earlier termination, of the Study at all participating sites, SPONSOR shall conduct, or cause to be conducted, such analyses of the data resulting from each site participating in the Multi-Center Study (\u201cMulti-Center Study Analyses\u201d) and, if requested, deliver the results of such analyses (\u201cMulti-Center Study Results\u201d) to the applicable Principal Investigator together with the underlying data relating only to Subjects enrolled in the Study at the Institution (\u201cSite Data\u201d), but not any other data and databases that are supplied, prepared, collected, developed or generated as a result of, in the performance of, or in connection with the Multi-Center Study at non Institution sites (\u201cMulti-Center Study Data\u201d). Further, for a Multi-Center Study, the SPONSOR, or its designee, shall have the right to coordinate one or more publications of the Multi-Center Study Results (each, a \u201cPublication\u201d). In case the Study is being conducted solely at the Institution, the SPONSOR will make the data available to the applicable Principal Investigator at the completion or earlier termination of the Study. Any access by Institution and/or its Principal Investigator to the Study Data from all Study sites for Institution and/or Principal Investigator will be addressed in the Study SOW.", "size": 6, "samples": [{"hash": "hKML9Ytfhk4", "uri": "/contracts/hKML9Ytfhk4#study-data", "label": "Master Clinical Study Agreement", "score": 28.2276661127, "published": true}, {"hash": "kcu9MtjlsAK", "uri": "/contracts/kcu9MtjlsAK#study-data", "label": "Master Clinical Study Agreement", "score": 27.5159505418, "published": true}, {"hash": "hUPYYYEo3Ez", "uri": "/contracts/hUPYYYEo3Ez#study-data", "label": "Master Clinical Study Agreement", "score": 27.5159505418, "published": true}], "snippet_links": [{"key": "the-institution", "type": "clause", "offset": [16, 31]}, {"key": "principal-investigator", "type": "definition", "offset": [51, 73]}, {"key": "acknowledge-and-agree", "type": "clause", "offset": [74, 95]}, {"key": "data-collected", "type": "clause", "offset": [105, 119]}, {"key": "during-the-study", "type": "clause", "offset": [120, 136]}, {"key": "except-as-otherwise-provided", "type": "clause", "offset": [153, 181]}, {"key": "section-158", "type": "clause", "offset": [185, 197]}, {"key": "by-sponsor", "type": "clause", "offset": [208, 218]}, {"key": "all-purposes", "type": "definition", "offset": [290, 302]}, {"key": "discretion-of-sponsor", "type": "clause", "offset": [315, 336]}, {"key": "applicable-laws-and-regulations", "type": "definition", "offset": [369, 400]}, {"key": "this-agreement", "type": "clause", "offset": [402, 416]}, {"key": "informed-consent-form", "type": "clause", "offset": [425, 446]}, {"key": "the-subject", "type": "clause", "offset": [457, 468]}, {"key": "earlier-termination", "type": "clause", "offset": [647, 666]}, {"key": "participating-sites", "type": "definition", "offset": [688, 707]}, {"key": "resulting-from", "type": "definition", "offset": [784, 798]}, {"key": "participating-in", "type": "definition", "offset": [809, 825]}, {"key": "the-multi", "type": "clause", "offset": [826, 835]}, {"key": "study-results", "type": "definition", "offset": [952, 965]}, {"key": "in-the-study", "type": "clause", "offset": [1078, 1090]}, {"key": "site-data", "type": "clause", "offset": [1112, 1121]}, {"key": "other-data", "type": "definition", "offset": [1137, 1147]}, {"key": "the-performance", "type": "clause", "offset": [1244, 1259]}, {"key": "in-connection-with", "type": "clause", "offset": [1267, 1285]}, {"key": "right-to", "type": "definition", "offset": [1443, 1451]}, {"key": "in-case", "type": "clause", "offset": [1547, 1554]}, {"key": "being-conducted", "type": "definition", "offset": [1568, 1583]}, {"key": "the-sponsor-will", "type": "clause", "offset": [1611, 1627]}, {"key": "available-to", "type": "definition", "offset": [1642, 1654]}, {"key": "termination-of-the-study", "type": "clause", "offset": [1722, 1746]}, {"key": "by-institution", "type": "clause", "offset": [1759, 1773]}, {"key": "study-sites", "type": "clause", "offset": [1835, 1846]}, {"key": "for-institution", "type": "definition", "offset": [1847, 1862]}], "hash": "dddbd1ab494e7eece245cc8c2b582f80", "id": 1}, {"snippet": "The Institution and Investigator agree to record all Study Data (including, without limitation, CRFs or eCRF\u2019s, laboratory work sheets, slides and reports) generated as a result of conducting the Study (collectively, the \u201cStudy Data\u201d) in a timely, accurate, complete, and legible manner in the form described in the Protocol and in compliance with all applicable laws and regulations. The Investigator shall take reasonable and customary precautions, including periodic backup of computer files, to prevent the loss or alteration of any Study Data. Investigator shall ensure that all information entered into the CRFs (or eCRFs) shall reflect the Trial Subject\u2019s true condition. The Investigator shall review all CRFs (or eCRFs) and check the data against all pertinent information in the Trial Subjects clinical records for accuracy and completeness of information, legibility of entries, correct any erroneous data, record use of concomitant drugs, report Adverse Events, concurrent illnesses and document reasons for any missing visits or examinations. The Institution and Investigator shall assist Pharm- Olam, Sponsor and/or Pharm-Olam\u2019s or Sponsor\u2019s representatives and Study monitors upon their request, in promptly resolving any discrepancies or errors contained in the CRFs (or eCRFs) and in performing random audits on Trial Subjects\u2019 records, laboratory reports, or other raw data sources underlying the data recorded on the CRFs (or eCRFs). During the Study, Pharm-Olam, or its representatives shall have the right upon prior notice and during normal business hours to review and verify and at times, to the extent allowed by law, copy (only pseudonymized or anonymized data), all Study Data including, without limitation, original reports of laboratory tests and examination findings, and all other notes, charts, reports, electronic health records or memoranda relating to Trial Subjects enrolled in the Study. In addition, during the Study and for a reasonable period (at least 5 years) following the completion of the Study, Pharm-Olam, Sponsor or their representatives shall have the right to review Trial Subject medical records or certified copies of any electronic health records relating to the Study only for auditing purposes according to applicable law. No later than ten (10) days after the completion or termination of the Study,", "size": 3, "samples": [{"hash": "hCFSYPDKtHV", "uri": "/contracts/hCFSYPDKtHV#study-data", "label": "Clinical Trial Agreement", "score": 28.1154340419, "published": true}], "snippet_links": [{"key": "to-record", "type": "definition", "offset": [39, 48]}, {"key": "without-limitation", "type": "clause", "offset": [76, 94]}, {"key": "work-sheets", "type": "clause", "offset": [123, 134]}, {"key": "the-protocol", "type": "clause", "offset": [312, 324]}, {"key": "compliance-with-all-applicable-laws-and-regulations", "type": "clause", "offset": [332, 383]}, {"key": "the-investigator", "type": "clause", "offset": [385, 401]}, {"key": "reasonable-and-customary", "type": "definition", "offset": [413, 437]}, {"key": "computer-files", "type": "clause", "offset": [480, 494]}, {"key": "all-information", "type": "clause", "offset": [580, 595]}, {"key": "entered-into", "type": "clause", "offset": [596, 608]}, {"key": "trial-subject", "type": "definition", "offset": [647, 660]}, {"key": "the-data", "type": "clause", "offset": [739, 747]}, {"key": "pertinent-information", "type": "clause", "offset": [760, 781]}, {"key": "clinical-records", "type": "clause", "offset": [804, 820]}, {"key": "accuracy-and-completeness-of-information", "type": "clause", "offset": [825, 865]}, {"key": "adverse-events", "type": "clause", "offset": [958, 972]}, {"key": "contained-in", "type": "definition", "offset": [1261, 1273]}, {"key": "random-audits", "type": "clause", "offset": [1312, 1325]}, {"key": "data-sources", "type": "definition", "offset": [1387, 1399]}, {"key": "during-the-study", "type": "clause", "offset": [1453, 1469]}, {"key": "the-right", "type": "clause", "offset": [1517, 1526]}, {"key": "prior-notice", "type": "clause", "offset": [1532, 1544]}, {"key": "normal-business-hours", "type": "definition", "offset": [1556, 1577]}, {"key": "to-the-extent-allowed-by-law", "type": "clause", "offset": [1613, 1641]}, {"key": "anonymized-data", "type": "clause", "offset": [1671, 1686]}, {"key": "reports-of", "type": "clause", "offset": [1744, 1754]}, {"key": "tests-and-examination", "type": "clause", "offset": [1766, 1787]}, {"key": "other-notes", "type": "definition", "offset": [1806, 1817]}, {"key": "electronic-health-records", "type": "definition", "offset": [1836, 1861]}, {"key": "relating-to", "type": "definition", "offset": [1875, 1886]}, {"key": "in-the-study", "type": "clause", "offset": [1911, 1923]}, {"key": "in-addition", "type": "clause", "offset": [1925, 1936]}, {"key": "reasonable-period", "type": "definition", "offset": [1965, 1982]}, {"key": "following-the", "type": "definition", "offset": [2002, 2015]}, {"key": "completion-of-the-study", "type": "clause", "offset": [2016, 2039]}, {"key": "right-to-review", "type": "clause", "offset": [2101, 2116]}, {"key": "medical-records", "type": "definition", "offset": [2131, 2146]}, {"key": "copies-of", "type": "definition", "offset": [2160, 2169]}, {"key": "according-to", "type": "definition", "offset": [2249, 2261]}, {"key": "days-after", "type": "definition", "offset": [2301, 2311]}, {"key": "termination-of-the-study", "type": "clause", "offset": [2330, 2354]}], "hash": "2e97cbb9bdf3a6e5d50ef0918214cb26", "id": 9}, {"snippet": "All information resulting from the Study conducted under this Agreement, including all data (including Subject-level data), results, and conclusions based on such data and/or results (hereinafter \u201cStudy Data\u201d) shall be owned exclusively by MSK.", "size": 3, "samples": [{"hash": "is5T6tqwaPL", "uri": "/contracts/is5T6tqwaPL#study-data", "label": "Investigator Sponsored Master Clinical Trial Agreement (Y-mAbs Therapeutics, Inc.)", "score": 27.643394935, "published": true}, {"hash": "j7pxP3FtAa1", "uri": "/contracts/j7pxP3FtAa1#study-data", "label": "Master Clinical Trial Agreement (Y-mAbs Therapeutics, Inc.)", "score": 27.2518822724, "published": true}], "snippet_links": [{"key": "all-information", "type": "clause", "offset": [0, 15]}, {"key": "the-study", "type": "definition", "offset": [31, 40]}, {"key": "this-agreement", "type": "clause", "offset": [57, 71]}, {"key": "based-on", "type": "clause", "offset": [149, 157]}], "hash": "500328d3d81ce5efdbbfea0e4e58c299", "id": 6}, {"snippet": "Institution shall record and maintain complete medical records (including, without limitation, case report forms, laboratory work sheets and reports, and all relevant source documents) generated as a result of conducting the Study (collectively, the \u201cStudy Data\u201d) in a timely, accurate, complete and legible manner in the form described in the Protocol. Studijn\u00ed data. Zdravotnick\u00e9 za\u0159\u00edzen\u00ed bude zaznamen\u00e1vat a udr\u017eovat kompletn\u00ed l\u00e9ka\u0159sk\u00e9 z\u00e1znamy (mimo jin\u00e9 v\u010detn\u011b formul\u00e1\u0159\u016f pro z\u00e1znamy o subjektech hodnocen\u00ed, laboratorn\u00edch z\u00e1znam\u016f a zpr\u00e1v a v\u0161ech p\u0159\u00edslu\u0161n\u00fdch zdrojov\u00fdch dokument\u016f) vytvo\u0159en\u00e9 v d\u016fsledku prov\u00e1d\u011bn\u00ed Studie (d\u00e1le spole\u010dn\u011b ozna\u010dov\u00e1ny jako \u201eStudijn\u00ed data\u201c) v\u010das, p\u0159esn\u011b, \u00fapln\u011b a \u010diteln\u011b podle pr\u00e1vn\u00edch p\u0159edpis\u016f ve form\u011b popsan\u00e9 v Protokolu.", "size": 3, "samples": [{"hash": "cDUokKDcbdZ", "uri": "/contracts/cDUokKDcbdZ#study-data", "label": "Clinical Trial Agreement", "score": 29.8755613959, "published": true}], "snippet_links": [{"key": "institution-shall", "type": "clause", "offset": [0, 17]}, {"key": "complete-medical-records", "type": "clause", "offset": [38, 62]}, {"key": "without-limitation", "type": "clause", "offset": [75, 93]}, {"key": "case-report-forms", "type": "definition", "offset": [95, 112]}, {"key": "work-sheets", "type": "clause", "offset": [125, 136]}, {"key": "source-documents", "type": "definition", "offset": [167, 183]}, {"key": "the-study", "type": "definition", "offset": [221, 230]}, {"key": "the-protocol", "type": "clause", "offset": [340, 352]}, {"key": "studijn\u00ed-data", "type": "clause", "offset": [354, 367]}, {"key": "zdravotnick\u00e9-za\u0159\u00edzen\u00ed", "type": "clause", "offset": [369, 390]}, {"key": "l\u00e9ka\u0159sk\u00e9-z\u00e1znamy", "type": "clause", "offset": [430, 446]}, {"key": "prov\u00e1d\u011bn\u00ed-studie", "type": "clause", "offset": [604, 620]}], "hash": "0d8b4e7695ae673a1c173e616d80ad3e", "id": 7}, {"snippet": "Institution and Investigator shall record and maintain complete medical records (including, without limitation, case report forms, laboratory work sheets and reports, and all relevant source documents) generated as a result of conducting the Study (collectively, the \u201cStudy Data\u201d) in a timely, accurate, complete and legible manner in the form described in the Protocol.", "size": 6, "samples": [{"hash": "hnx0GQe5rwB", "uri": "/contracts/hnx0GQe5rwB#study-data", "label": "Clinical Trial Agreement", "score": 30.5231682046, "published": true}, {"hash": "euOAt8tKIed", "uri": "/contracts/euOAt8tKIed#study-data", "label": "Clinical Trial Agreement", "score": 30.0088315741, "published": true}, {"hash": "7OJWco0pfq2", "uri": "/contracts/7OJWco0pfq2#study-data", "label": "Clinical Trial Agreement", "score": 22.9822039699, "published": true}], "snippet_links": [{"key": "institution-and-investigator", "type": "clause", "offset": [0, 28]}, {"key": "complete-medical-records", "type": "clause", "offset": [55, 79]}, {"key": "without-limitation", "type": "clause", "offset": [92, 110]}, {"key": "case-report-forms", "type": "definition", "offset": [112, 129]}, {"key": "work-sheets", "type": "clause", "offset": [142, 153]}, {"key": "source-documents", "type": "definition", "offset": [184, 200]}, {"key": "the-study", "type": "definition", "offset": [238, 247]}, {"key": "the-protocol", "type": "clause", "offset": [357, 369]}], "hash": "9e2d455c0e37d07849556ffac9c5dc0e", "id": 2}, {"snippet": "During the course of the Study, Principal Investigator has agreed to collect certain data, and submit it to CRO, Pfizer or Pfizer\u2019s agent (\u201cStudy Data\u201d) as specified in the protocol. Study Data may include Personal Data of Study Subjects. Principal Investigator will ensure accurate and timely collection, recording, and submission of Study Data, including adhering to timelines for data entry set out in the CRF Completion Requirements document provided to Principal Investigator by CRO or Pfizer. Institution will cooperate with Principal Investigator if and as needed to facilitate compliance by Principal Investigator with this obligation. a.", "size": 6, "samples": [{"hash": "k2mB0Axt7dg", "uri": "/contracts/k2mB0Axt7dg#study-data", "label": "Clinical Study Agreement", "score": 33.0435565194, "published": true}, {"hash": "1ve0Tcx1qQN", "uri": "/contracts/1ve0Tcx1qQN#study-data", "label": "Clinical Study Agreement", "score": 32.961435492, "published": true}], "snippet_links": [{"key": "the-study", "type": "definition", "offset": [21, 30]}, {"key": "agreed-to", "type": "clause", "offset": [59, 68]}, {"key": "certain-data", "type": "clause", "offset": [77, 89]}, {"key": "as-specified", "type": "clause", "offset": [153, 165]}, {"key": "the-protocol", "type": "clause", "offset": [169, 181]}, {"key": "personal-data-of-study-subjects", "type": "clause", "offset": [206, 237]}, {"key": "submission-of", "type": "clause", "offset": [321, 334]}, {"key": "data-entry", "type": "definition", "offset": [383, 393]}, {"key": "set-out", "type": "definition", "offset": [394, 401]}, {"key": "requirements-document", "type": "definition", "offset": [424, 445]}, {"key": "to-principal-investigator", "type": "clause", "offset": [455, 480]}, {"key": "by-cro", "type": "clause", "offset": [481, 487]}, {"key": "cooperate-with", "type": "clause", "offset": [516, 530]}, {"key": "as-needed", "type": "clause", "offset": [561, 570]}, {"key": "by-principal", "type": "definition", "offset": [596, 608]}], "hash": "0eae345f3a2f620d5dec798a335e4f54", "id": 3}, {"snippet": "During the course of the Study, Principal Investigator will collect certain data, as specified in the Protocol, and submit it to CRO, Pfizer or Pfizer\u2019s agent (\u201cStudy Data\u201d). Principal Investigator will ensure accurate and timely collection, recording, and submission of Study Data, including adhering to timelines for data entry set out in the CRF Completion Requirements document provided to Principal Investigator by CRO or Pfizer.\n11.1 Studijn\u00ed \u00fadaje studie. B\u011bhem studie shrom\u00e1\u017ed\u00ed Hlavn\u00ed zkou\u0161ej\u00edc\u00ed ur\u010dit\u00e9 \u00fadaje uveden\u00e9 v Protokolu, a p\u0159edlo\u017e\u00ed je CRO, spole\u010dnosti Pfizer nebo z\u00e1stupci spole\u010dnosti Pfizer (d\u00e1le jen \u201eStudijn\u00ed \u00fadaje \u201c). Hlavn\u00ed zkou\u0161ej\u00edc\u00ed zajist\u00ed v\u010dasn\u00e9 shrom\u00e1\u017ed\u011bn\u00ed, zaznamen\u00e1n\u00ed a p\u0159edlo\u017een\u00ed Studijn\u00edch \u00fadaj\u016f, v\u010detn\u011b dodr\u017eov\u00e1n\u00ed \u010dasov\u00e9ho harmonogramu zad\u00e1v\u00e1n\u00ed \u00fadaj\u016f stanoven\u00e9ho v dokumentu Po\u017eadavky na vypln\u011bn\u00ed Z\u00e1znamn\u00edku subjektu hodnocen\u00ed, kter\u00fd Hlavn\u00edmu zkou\u0161ej\u00edc\u00edmu poskytne CRO nebo spole\u010dnost Pfizer.", "size": 4, "samples": [{"hash": "jc0CHPv6MsF", "uri": "/contracts/jc0CHPv6MsF#study-data", "label": "Clinical Study Agreement", "score": 28.6399929162, "published": true}, {"hash": "hl1Yv8C51bX", "uri": "/contracts/hl1Yv8C51bX#study-data", "label": "Clinical Study Agreement", "score": 27.6536797541, "published": true}], "snippet_links": [{"key": "the-study", "type": "definition", "offset": [21, 30]}, {"key": "certain-data", "type": "clause", "offset": [68, 80]}, {"key": "as-specified", "type": "clause", "offset": [82, 94]}, {"key": "the-protocol", "type": "clause", "offset": [98, 110]}, {"key": "submission-of", "type": "clause", "offset": [257, 270]}, {"key": "data-entry", "type": "definition", "offset": [319, 329]}, {"key": "set-out", "type": "definition", "offset": [330, 337]}, {"key": "requirements-document", "type": "definition", "offset": [360, 381]}, {"key": "to-principal-investigator", "type": "clause", "offset": [391, 416]}, {"key": "by-cro", "type": "clause", "offset": [417, 423]}, {"key": "hlavn\u00ed-zkou\u0161ej\u00edc\u00ed", "type": "clause", "offset": [486, 503]}], "hash": "23babc1d144abdb9a5b0b924764a27ea", "id": 4}, {"snippet": "COMPANY shall own all right, title, and interest in and to all Study Data, and all reports and biological or chemical specimens generated by METRICS as a result of conducting the Services. All Study Data and any information with respect thereto shall be COMPANY Confidential Information subject to the confidentiality provisions of Section 5.", "size": 3, "samples": [{"hash": "ey73GJbd67n", "uri": "/contracts/ey73GJbd67n#study-data", "label": "Standard Development Agreement (CymaBay Therapeutics, Inc.)", "score": 24.8521560575, "published": true}, {"hash": "Zt1yLFjvD9", "uri": "/contracts/Zt1yLFjvD9#study-data", "label": "Standard Development Agreement (CymaBay Therapeutics, Inc.)", "score": 24.7919233402, "published": true}, {"hash": "bF5Vrj5o9MZ", "uri": "/contracts/bF5Vrj5o9MZ#study-data", "label": "Standard Development Agreement (CymaBay Therapeutics, Inc.)", "score": 24.7152635181, "published": true}], "snippet_links": [{"key": "and-interest", "type": "clause", "offset": [36, 48]}, {"key": "the-services", "type": "definition", "offset": [175, 187]}, {"key": "company-confidential-information", "type": "clause", "offset": [254, 286]}, {"key": "provisions-of", "type": "clause", "offset": [318, 331]}, {"key": "section-5", "type": "clause", "offset": [332, 341]}], "hash": "42f292332eb24f258f5ff70fd7ee0887", "id": 5}, {"snippet": "During the course of the Study, Principal Investigator has agreed to collect certain data, as specified in the Protocol, and submit it to CRO, Pfizer or Pfizer\u2019s agent (\u201cStudy Data\u201d). Principal Investigator will ensure accurate and timely 11.1 \u00dadaje klinick\u00e9ho hodnocen\u00ed. Hlavn\u00ed zkou\u0161ej\u00edc\u00ed souhlas\u00ed, \u017ee b\u011bhem klinick\u00e9ho hodnocen\u00ed shrom\u00e1\u017ed\u00ed ur\u010dit\u00e9 \u00fadaje tak, jak jsou tyto definov\u00e1ny v protokolu, a p\u0159edlo\u017e\u00ed je CRO, spole\u010dnosti Pfizer nebo z\u00e1stupci spole\u010dnosti Pfizer (d\u00e1le jen \u201e\u00fadaje klinick\u00e9ho hodnocen\u00ed\u201c). Hlavn\u00ed collection, recording, and submission of Study Data, including adhering to timelines for data entry set out in the CRF Completion Requirements document provided to Principal Investigator by CRO or Pfizer. 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