{"component": "clause", "props": {"groups": [{"snippet": "The Investigator is responsible for maintaining adequate and accurate medical records from which accurate information will be transferred into the study database. Case Report Forms (CRFs) should be completed by the Investigator or delegated personnel. CRFs will be provided for each patient. All data will be entered in black ink. Data/corrections entered will be signed or initialed by the study personnel undertaking that procedure. Overwriting data or use of liquid correcting fluid is not allowed. Detailed instructions are provided with the CRF.", "snippet_links": [{"key": "the-investigator", "type": "clause", "offset": [0, 16]}, {"key": "responsible-for", "type": "clause", "offset": [20, 35]}, {"key": "medical-records", "type": "definition", "offset": [70, 85]}, {"key": "accurate-information", "type": "clause", "offset": [97, 117]}, {"key": "the-study", "type": "definition", "offset": [143, 152]}, {"key": "completed-by", "type": "clause", "offset": [198, 210]}, {"key": "study-personnel", "type": "definition", "offset": [391, 406]}, {"key": "not-allowed", "type": "clause", "offset": [489, 500]}, {"key": "detailed-instructions", "type": "clause", "offset": [502, 523]}], "size": 7, "samples": [{"hash": "aqqfj3FR3dp", "uri": "/contracts/aqqfj3FR3dp#case-report-forms", "label": "License and Commercialization Agreement (Bellerophon Therapeutics, Inc.)", "score": 26.2429842574, "published": true}, {"hash": "eqgtMpj78Xc", "uri": "/contracts/eqgtMpj78Xc#case-report-forms", "label": "License and Commercialization Agreement (Bellerophon Therapeutics LLC)", "score": 26.0321697467, "published": true}, {"hash": "117iSGFYTmU", "uri": "/contracts/117iSGFYTmU#case-report-forms", "label": "License and Commercialization Agreement (Bellerophon Therapeutics LLC)", "score": 25.3641341547, "published": true}], "hash": "97344b821d98fde7deaafadd6036a94e", "id": 1}, {"snippet": "For all subjects enrolled in the Study, Institution and Investigator will promptly complete and allow Sponsor and/or its designees' access to all case report forms (\u201cCRFs\u201d) required for the Study in the form supplied by 4.7 Z\u00e1znamy subjektu hodnocen\u00ed. Nemocnice a zkou\u0161ej\u00edc\u00ed neprodlen\u011b vypln\u00ed za v\u0161echny subjekty za\u0159azen\u00e9 do studie a umo\u017en\u00ed zadavateli a/nebo j\u00edm pov\u011b\u0159en\u00fdm osob\u00e1m p\u0159\u00edstup ke v\u0161em z\u00e1znam\u016fm subjektu hodnocen\u00ed (d\u00e1le jen \u201eCRF\u201c) vy\u017eadovan\u00fdm Sponsor or its designee. Institution and Investigator will not be required to disclose information in CRFs which would permit identification of a subject enrolled in, or a candidate for, the Study. CRFs will be provided to Sponsor or its designees in a form or electronic medium specified by Sponsor or its designees. At the request of Sponsor or its designees, Institution or Investigator will promptly correct any errors and/or omissions to the CRFs for the Study and will make available to Sponsor and/or its designees the corrected CRFs and supporting records for further verification. Investigator agrees to sign a statement in each eCRF attesting to his/her review of the CRF and verifying that the information included on such form is accurate and complete and includes the treatment, care, and events surrounding such subject\u2019s involvement in the Study. pro studii ve form\u011b, v jak\u00e9 je dodal zadavatel nebo j\u00edm pov\u011b\u0159en\u00e1 osoba. Od nemocnice ani od zkou\u0161ej\u00edc\u00edho nebude vy\u017eadov\u00e1no, aby ve formul\u00e1\u0159\u00edch CRF uv\u00e1d\u011bli informace, kter\u00e9 by umo\u017enily identifikaci subjekt\u016f za\u0159azen\u00fdch do studie, ani subjekt\u016f, kter\u00e9 by do studie mohly b\u00fdt za\u0159azeny. Formul\u00e1\u0159e CRF budou p\u0159ed\u00e1ny zadavateli nebo j\u00edm pov\u011b\u0159en\u00fdm osob\u00e1m na formul\u00e1\u0159i nebo na elektronick\u00e9m m\u00e9diu stanoven\u00e9m zadavatelem nebo j\u00edm pov\u011b\u0159en\u00fdmi osobami. Na \u017e\u00e1dost zadavatele nebo j\u00edm pov\u011b\u0159en\u00fdch osob oprav\u00ed nemocnice nebo zkou\u0161ej\u00edc\u00ed neprodlen\u011b ve\u0161ker\u00e9 chyby a/nebo opomenut\u00ed ve formul\u00e1\u0159\u00edch CRF spojen\u00fdch se studi\u00ed a zp\u0159\u00edstupn\u00ed zadavateli a/nebo j\u00edm pov\u011b\u0159en\u00fdm osob\u00e1m opraven\u00e9 formul\u00e1\u0159e CRF a podp\u016frn\u00e9 z\u00e1znamy pro dal\u0161\u00ed ov\u011b\u0159en\u00ed. Zkou\u0161ej\u00edc\u00ed souhlas\u00ed s t\u00edm, \u017ee podep\u00ed\u0161e prohl\u00e1\u0161en\u00ed ve v\u0161ech CRF, kter\u00e9 potvrzuje, \u017ee provedl kontrolu formul\u00e1\u0159e CRF a ov\u011b\u0159il, \u017ee informace v n\u011bm obsa\u017een\u00e9 jsou p\u0159esn\u00e9 a \u00fapln\u00e9 a obsahuj\u00ed l\u00e9\u010dbu, p\u00e9\u010di a p\u0159\u00edhody, kter\u00e9 prob\u011bhly v r\u00e1mci zapojen\u00ed dan\u00e9ho subjektu do studie.", "snippet_links": [{"key": "in-the-study", "type": "clause", "offset": [26, 38]}, {"key": "institution-and-investigator", "type": "clause", "offset": [40, 68]}, {"key": "access-to", "type": "definition", "offset": [132, 141]}, {"key": "z\u00e1znamy-subjektu-hodnocen\u00ed", "type": "clause", "offset": [224, 250]}, {"key": "to-disclose-information", "type": "clause", "offset": [528, 551]}, {"key": "electronic-medium", "type": "definition", "offset": [714, 731]}, {"key": "by-sponsor", "type": "clause", "offset": [742, 752]}, {"key": "the-request", "type": "clause", "offset": [774, 785]}, {"key": "errors-and-or-omissions", "type": "clause", "offset": [869, 892]}, {"key": "available-to", "type": "definition", "offset": [933, 945]}, {"key": "supporting-records", "type": "definition", "offset": [998, 1016]}, {"key": "agrees-to", "type": "clause", "offset": [1056, 1065]}, {"key": "review-of-the", "type": "clause", "offset": [1117, 1130]}, {"key": "information-included", "type": "clause", "offset": [1158, 1178]}, {"key": "accurate-and-complete", "type": "clause", "offset": [1195, 1216]}], "size": 5, "samples": [{"hash": "aeVu6CK4EzA", "uri": "/contracts/aeVu6CK4EzA#case-report-forms", "label": "Clinical Trial Agreement", "score": 27.5725744278, "published": true}], "hash": "29b0578ee3e877a7050daee9e664d410", "id": 2}, {"snippet": "The Sponsor will provide the INSTITUTION with a sufficient quantity of Case Report Forms (\"CRF's\"), necessary questionnaires or other required documentation to conduct the Study. All original CRF's will be the sole property of the SPONSOR. All other original records of the work completed under this Agreement, including patient medical records, laboratory records and reports, scans, films and information on pre-existing INSTITUTION databases will be INSTITUTION property. INSTITUTION will retain a copy of all Study documents for internal research, teaching and archival purposes. FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS - The INSTITUTION must, if necessary, ensure that all investigators listed in the Study protocol and conducting the Study provide the SPONSOR with all information on their significant financial commitments, such as patent and all other intellectual property rights related to the Study, ownership of shares in the Study Devices.", "snippet_links": [{"key": "the-institution", "type": "clause", "offset": [25, 40]}, {"key": "quantity-of", "type": "clause", "offset": [59, 70]}, {"key": "other-required-documentation", "type": "clause", "offset": [128, 156]}, {"key": "sole-property", "type": "clause", "offset": [210, 223]}, {"key": "work-completed", "type": "clause", "offset": [274, 288]}, {"key": "this-agreement", "type": "clause", "offset": [295, 309]}, {"key": "patient-medical-records", "type": "clause", "offset": [321, 344]}, {"key": "records-and-reports", "type": "clause", "offset": [357, 376]}, {"key": "information-on", "type": "clause", "offset": [395, 409]}, {"key": "institution-property", "type": "definition", "offset": [453, 473]}, {"key": "a-copy-of", "type": "clause", "offset": [499, 508]}, {"key": "study-documents", "type": "definition", "offset": [513, 528]}, {"key": "internal-research", "type": "definition", "offset": [533, 550]}, {"key": "financial-disclosure", "type": "definition", "offset": [584, 604]}, {"key": "clinical-investigators", "type": "definition", "offset": [608, 630]}, {"key": "study-protocol", "type": "definition", "offset": [713, 727]}, {"key": "all-information", "type": "clause", "offset": [778, 793]}, {"key": "financial-commitments", "type": "definition", "offset": [815, 836]}, {"key": "other-intellectual-property-rights", "type": "definition", "offset": [861, 895]}, {"key": "related-to", "type": "clause", "offset": [896, 906]}, {"key": "ownership-of-shares", "type": "clause", "offset": [918, 937]}], "size": 4, "samples": [{"hash": "gHLKcRxbO3h", "uri": "/contracts/gHLKcRxbO3h#case-report-forms", "label": "Clinical Study Agreement", "score": 32.9163211133, "published": true}, {"hash": "7AA9Zuw6rD2", "uri": "/contracts/7AA9Zuw6rD2#case-report-forms", "label": "Clinical Study Agreement", "score": 32.9163211133, "published": true}, {"hash": "2tH6nAFyE9Q", "uri": "/contracts/2tH6nAFyE9Q#case-report-forms", "label": "Clinical Study Agreement", "score": 23.4435318275, "published": true}], "hash": "3aadb81c0f27d6fb2b5ee823e7d1a352", "id": 3}, {"snippet": "[***] is responsible for the development and subsequent revisions of case report forms for Clinical Studies (\u201cCRF\u201d) subject to review and approval of the CSOG. Sponsor will be responsible for distributing the CRFs and any amendments to the CRFs to all Participating Sites in a timely manner. For each Clinical Study conducted at MSKCC, MSKCC shall prepare and maintain CRFs and other patient records and case histories with all pertinent data documented as required by the applicable Study Protocol. Sponsor shall not disclose patient names, except to the extent that the patient consent form permits or as required by applicable law or regulation. All CRFs shall be owned by Sponsor.", "snippet_links": [{"key": "responsible-for", "type": "clause", "offset": [9, 24]}, {"key": "the-development", "type": "clause", "offset": [25, 40]}, {"key": "subsequent-revisions", "type": "clause", "offset": [45, 65]}, {"key": "clinical-studies", "type": "clause", "offset": [91, 107]}, {"key": "subject-to", "type": "definition", "offset": [116, 126]}, {"key": "approval-of", "type": "clause", "offset": [138, 149]}, {"key": "be-responsible", "type": "clause", "offset": [173, 187]}, {"key": "amendments-to-the", "type": "clause", "offset": [222, 239]}, {"key": "participating-sites", "type": "definition", "offset": [252, 271]}, {"key": "in-a-timely-manner", "type": "definition", "offset": [272, 290]}, {"key": "clinical-study", "type": "clause", "offset": [301, 315]}, {"key": "patient-records", "type": "clause", "offset": [384, 399]}, {"key": "pertinent-data", "type": "clause", "offset": [428, 442]}, {"key": "as-required-by", "type": "clause", "offset": [454, 468]}, {"key": "the-applicable", "type": "clause", "offset": [469, 483]}, {"key": "study-protocol", "type": "definition", "offset": [484, 498]}, {"key": "except-to-the-extent", "type": "clause", "offset": [542, 562]}, {"key": "patient-consent-form", "type": "definition", "offset": [572, 592]}, {"key": "applicable-law-or-regulation", "type": "definition", "offset": [619, 647]}, {"key": "by-sponsor", "type": "clause", "offset": [673, 683]}], "size": 3, "samples": [{"hash": "ixPjYSGsuGd", "uri": "/contracts/ixPjYSGsuGd#case-report-forms", "label": "Master Clinical Study Agreement", "score": 31.340862423, "published": true}, {"hash": "fhsVDyK98ck", "uri": "/contracts/fhsVDyK98ck#case-report-forms", "label": "Master Clinical Study Agreement (Juno Therapeutics, Inc.)", "score": 25.9555099247, "published": true}, {"hash": "inqvQD2NENd", "uri": "/contracts/inqvQD2NENd#case-report-forms", "label": "Master Clinical Study Agreement (Juno Therapeutics, Inc.)", "score": 25.8761122519, "published": true}], "hash": "6cb90b3614b848c0c43f0fdcd167e2da", "id": 4}, {"snippet": "For all subjects enrolled in the Study, Institution or Investigator will complete all case report forms required for the Study in the form and/or electronic medium supplied or specified by Sponsor and/or CRO (the \u201cCRFs\u201d) within twenty-four (24) hours of the subject visit during the dose escalation phase and within three (3) days of the subject visit for the remainder of the Study. Institution and Investigator will not be required to disclose information in CRFs which would permit personal identification of a subject enrolled in, or a candidate for, the Study. CRFs will be provided to CRO in a timely manner as they are completed. At the request of Sponsor and/or CRO, Institution or Investigator will promptly correct any errors and/or omissions to the CRFs for the Study and will make available to Sponsor and/or CRO the corrected CRFs and supporting records for further verification.", "snippet_links": [{"key": "in-the-study", "type": "clause", "offset": [26, 38]}, {"key": "forms-required", "type": "clause", "offset": [98, 112]}, {"key": "electronic-medium", "type": "definition", "offset": [146, 163]}, {"key": "by-sponsor", "type": "clause", "offset": [186, 196]}, {"key": "hours-of", "type": "clause", "offset": [245, 253]}, {"key": "the-subject", "type": "clause", "offset": [254, 265]}, {"key": "institution-and-investigator", "type": "clause", "offset": [384, 412]}, {"key": "to-disclose-information", "type": "clause", "offset": [434, 457]}, {"key": "personal-identification", "type": "clause", "offset": [485, 508]}, {"key": "in-a-timely-manner", "type": "definition", "offset": [595, 613]}, {"key": "the-request", "type": "clause", "offset": [640, 651]}, {"key": "errors-and-or-omissions", "type": "clause", "offset": [729, 752]}, {"key": "available-to", "type": "definition", "offset": [793, 805]}, {"key": "supporting-records", "type": "definition", "offset": [848, 866]}], "size": 3, "samples": [{"hash": "fGgD6JSx0oI", "uri": "/contracts/fGgD6JSx0oI#case-report-forms", "label": "Clinical Trial Agreement", "score": 25.6634332871, "published": true}, {"hash": "7OJWco0pfq2", "uri": "/contracts/7OJWco0pfq2#case-report-forms", "label": "Clinical Trial Agreement", "score": 22.9822039699, "published": true}], "hash": "6d07e6d854dffcdba951cf148c543cec", "id": 5}, {"snippet": "The Institution shall ensure that the Investigator or his/her designee shall complete Case Report Forms, provided by the Sponsor or ICON and shall submit them within forty eight (48) hours of obtaining the data. The Institution shall ensure that the Investigator is in any case responsible for the completion and submission of the Case Report Forms. The Institution shall ensure that the Investigator shall be present and give these forms and make available any source documents related to the Study, to representatives of Sponsor or ICON at periodic monitoring visits or otherwise promptly upon request. Such ICON monitoring visits and data collection shall be conducted approximately every 8-12 weeks. The Institution shall ensure that the Investigator shall fully assist, in a timely manner, ICON representatives in resolving any discrepancies, errors or missing information in Case Report Forms. The Institution shall ensure that the Investigator shall help ICON in conducting audits of original case records, laboratory reports, and/or raw data sources underlying data recorded in the Case Report Forms. Such audits shall be conducted with due regard for patient confidentiality. The Institution understands that failure to resolve Zdravotnick\u00e9 za\u0159\u00edzen\u00ed zajist\u00ed, \u017ee zkou\u0161ej\u00edc\u00ed \u2587\u2587\u2587\u2587 \u2587\u2587\u2587 zmocn\u011bn\u00e1 osoba vypln\u00ed z\u00e1znamy subjektu hodnocen\u00ed poskytnut\u00e9 zadavatelem nebo spole\u010dnost\u00ed ICON, a tyto formul\u00e1\u0159e do 48 hodin od okam\u017eiku z\u00edsk\u00e1n\u00ed \u00fadaj\u016f ode\u0161le. Zdravotnick\u00e9 za\u0159\u00edzen\u00ed zajist\u00ed, \u017ee za vypln\u011bn\u00ed a p\u0159ed\u00e1n\u00ed z\u00e1znam\u016f subjektu hodnocen\u00ed v\u017edy odpov\u00edd\u00e1 zkou\u0161ej\u00edc\u00ed. Zdravotnick\u00e9 za\u0159\u00edzen\u00ed zajist\u00ed, \u017ee se zkou\u0161ej\u00edc\u00ed z\u00fa\u010dastn\u00ed pravideln\u00fdch monitorovac\u00edch n\u00e1v\u0161t\u011bv a na po\u017e\u00e1d\u00e1n\u00ed na t\u011bchto n\u00e1v\u0161t\u011bv\u00e1ch nebo jinak bez prodlen\u00ed p\u0159ed\u00e1 tyto z\u00e1znamy z\u00e1stupc\u016fm zadavatele nebo spole\u010dnosti ICON a zp\u0159\u00edstupn\u00ed \u2587\u2587\u2587 jak\u00e9koli zdrojov\u00e9 dokumenty souvisej\u00edc\u00ed s klinick\u00fdm hodnocen\u00edm. Tyto monitorovac\u00ed n\u00e1v\u0161t\u011bvy spole\u010dnosti ICON a shroma\u017e\u010fov\u00e1n\u00ed \u00fadaj\u016f se uskute\u010dn\u00ed p\u0159ibli\u017en\u011b jednou za 8-12 t\u00fddn\u016f. Zdravotnick\u00e9 za\u0159\u00edzen\u00ed zajist\u00ed, \u017ee zkou\u0161ej\u00edc\u00ed poskytne z\u00e1stupc\u016fm spole\u010dnosti ICON \u00faplnou a v\u010dasnou sou\u010dinnost p\u0159i \u0159e\u0161en\u00ed jak\u00fdchkoli rozpor\u016f, chyb \u010di chyb\u011bj\u00edc\u00edch informac\u00ed v z\u00e1znamech subjektu hodnocen\u00ed. Zdravotnick\u00e9 za\u0159\u00edzen\u00ed zajist\u00ed, \u017ee zkou\u0161ej\u00edc\u00ed poskytne spole\u010dnosti ICON pomoc p\u0159i uskute\u010d\u0148ov\u00e1n\u00ed audit\u016f p\u016fvodn\u00edch z\u00e1znam\u016f subjekt\u016f, laboratorn\u00edch zpr\u00e1v, a/nebo nezpracovan\u00fdch zdrojov\u00fdch \u00fadaj\u016f, je\u017e jsou podkladem pro data uveden\u00e1 v z\u00e1znamech subjektu hodnocen\u00ed. Tyto audity budou provedeny s \u0159\u00e1dn\u00fdm zohledn\u011bn\u00edm d\u016fv\u011brnosti pacient\u016f. Zdravotnick\u00e9 za\u0159\u00edzen\u00ed discrepancies, errors or missing information in Case Report Forms may result in payment being withheld until resolution. si je v\u011bdomo, \u017ee pokud nebudou odstran\u011bny rozpory \u010di chyby nebo dopln\u011bny chyb\u011bj\u00edc\u00ed informace v z\u00e1znamech subjektu hodnocen\u00ed, m\u016f\u017ee to m\u00edt za n\u00e1sledek zadr\u017een\u00ed platby a\u017e do vy\u0159e\u0161en\u00ed p\u0159\u00edslu\u0161n\u00e9 z\u00e1le\u017eitosti.", "snippet_links": [{"key": "institution-shall", "type": "clause", "offset": [4, 21]}, {"key": "the-investigator", "type": "clause", "offset": [34, 50]}, {"key": "the-sponsor", "type": "clause", "offset": [117, 128]}, {"key": "hours-of", "type": "clause", "offset": [183, 191]}, {"key": "the-data", "type": "clause", "offset": [202, 210]}, {"key": "responsible-for", "type": "clause", "offset": [278, 293]}, {"key": "submission-of-the", "type": "clause", "offset": [313, 330]}, {"key": "make-available", "type": "definition", "offset": [443, 457]}, {"key": "source-documents", "type": "definition", "offset": [462, 478]}, {"key": "related-to", "type": "clause", "offset": [479, 489]}, {"key": "the-study", "type": "definition", "offset": [490, 499]}, {"key": "representatives-of", "type": "clause", "offset": [504, 522]}, {"key": "monitoring-visits", "type": "clause", "offset": [551, 568]}, {"key": "upon-request", "type": "definition", "offset": [591, 603]}, {"key": "data-collection", "type": "clause", "offset": [637, 652]}, {"key": "in-a-timely-manner", "type": "definition", "offset": [775, 793]}, {"key": "missing-information", "type": "clause", "offset": [858, 877]}, {"key": "in-case", "type": "clause", "offset": [878, 885]}, {"key": "case-records", "type": "clause", "offset": [1000, 1012]}, {"key": "data-sources", "type": "definition", "offset": [1045, 1057]}, {"key": "in-the-case", "type": "clause", "offset": [1083, 1094]}, {"key": "due-regard", "type": "definition", "offset": [1145, 1155]}, {"key": "patient-confidentiality", "type": "clause", "offset": [1160, 1183]}, {"key": "failure-to-resolve", "type": "clause", "offset": [1218, 1236]}, {"key": "zdravotnick\u00e9-za\u0159\u00edzen\u00ed", "type": "clause", "offset": [1237, 1258]}, {"key": "z\u00e1znamy-subjektu-hodnocen\u00ed", "type": "clause", "offset": [1313, 1339]}, {"key": "zdrojov\u00e9-dokumenty", "type": "clause", "offset": [1798, 1816]}, {"key": "in-payment", "type": "clause", "offset": [2594, 2604]}], "size": 3, "samples": [{"hash": "ePtZDj7MMAx", "uri": "/contracts/ePtZDj7MMAx#case-report-forms", "label": "Clinical Trial Agreement", "score": 31.7222688114, "published": true}], "hash": "69056af76110ddc29138317e092d922a", "id": 6}, {"snippet": "For all subjects enrolled in the Study, Institution shall ensure that the Investigator will complete all case report forms required for the Study in the form supplied or specified by Sponsor and/or CRO (the \u201cCRFs\u201d) and within the timeframe specified by Sponsor and/or CRO. Institution will not be required to disclose information in CRFs which would permit identification of a subject enrolled in, or a candidate for, the Study and should ensure that the Investigator will not disclose such information. Institution will ensure that CRFs will be completed within 5 business days after visit occurred. At the request of Sponsor and/or CRO, Institution will ensure that the Investigator will promptly (within 5 business days) correct any errors and/or omissions to the CRFs for the Study and will make available to Sponsor and/or CRO the corrected CRFs and supporting records for further verification.", "snippet_links": [{"key": "in-the-study", "type": "clause", "offset": [26, 38]}, {"key": "institution-shall", "type": "clause", "offset": [40, 57]}, {"key": "the-investigator", "type": "clause", "offset": [70, 86]}, {"key": "forms-required", "type": "clause", "offset": [117, 131]}, {"key": "by-sponsor", "type": "clause", "offset": [180, 190]}, {"key": "to-disclose-information", "type": "clause", "offset": [306, 329]}, {"key": "such-information", "type": "definition", "offset": [486, 502]}, {"key": "days-after", "type": "definition", "offset": [574, 584]}, {"key": "the-request", "type": "clause", "offset": [604, 615]}, {"key": "errors-and-or-omissions", "type": "clause", "offset": [736, 759]}, {"key": "available-to", "type": "definition", "offset": [800, 812]}, {"key": "supporting-records", "type": "definition", "offset": [855, 873]}], "size": 2, "samples": [{"hash": "V64rOxIKOB", "uri": "/contracts/V64rOxIKOB#case-report-forms", "label": "Clinical Trial Agreement", "score": 27.016888809, "published": true}, {"hash": "7HD5jUJx8EY", "uri": "/contracts/7HD5jUJx8EY#case-report-forms", "label": "Clinical Trial Agreement", "score": 27.016888809, "published": true}], "hash": "c98a164f14c1efe10b3fa0613615cc64", "id": 7}, {"snippet": "zad\u00e1vate\u013e bez \u00fahrady poskytne sk\u00fa\u0161aj\u00facemu sk\u00fa\u0161an\u00fd produkt, kompar\u00e1tor, placebo a dokumenty ne- vyhnutn\u00e9 pre vedenie sk\u00fa\u0161ania (napr. \u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587 \u2587\u2587\u2587\u2587\u2587- \u2587\u2587\u2587\u2587 \u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587 klinick\u00e9ho sk\u00fa\u0161ania).", "snippet_links": [], "size": 2, "samples": [{"hash": "8ABRmEHKhDK", "uri": "/contracts/8ABRmEHKhDK#case-report-forms", "label": "Clinical Trial Agreement", "score": 27.1645517905, "published": true}, {"hash": "grOals9t9eD", "uri": "/contracts/grOals9t9eD#case-report-forms", "label": "Clinical Trial Agreement", "score": 26.8388050484, "published": true}], "hash": "d7f56e02f2d133ac87c458d6a83c630d", "id": 8}, {"snippet": "Medpace will design the electronic case report forms (eCRFs) for the trial, including completion instructions, according to the final protocols and the Medpace template. VIVUS must review and approve the eCRFs before they are finalized. Prior to the study site initiation visits, a project kickoff meeting will be held at Medpace involving Medpace and VIVUS personnel to review the study protocol, eCRFs, and overall project coordination. Medpace project team members and VIVUS personnel will participate in this meeting.", "snippet_links": [{"key": "the-electronic", "type": "clause", "offset": [20, 34]}, {"key": "the-trial", "type": "clause", "offset": [65, 74]}, {"key": "completion-instructions", "type": "clause", "offset": [86, 109]}, {"key": "according-to", "type": "definition", "offset": [111, 123]}, {"key": "the-final", "type": "clause", "offset": [124, 133]}, {"key": "review-and-approve", "type": "clause", "offset": [181, 199]}, {"key": "study-site", "type": "definition", "offset": [250, 260]}, {"key": "project-kickoff-meeting", "type": "clause", "offset": [282, 305]}, {"key": "study-protocol", "type": "definition", "offset": [382, 396]}, {"key": "overall-project-coordination", "type": "clause", "offset": [409, 437]}, {"key": "project-team-members", "type": "clause", "offset": [447, 467]}, {"key": "participate-in", "type": "definition", "offset": [493, 507]}], "size": 2, "samples": [{"hash": "gWR6eqkVEur", "uri": "/contracts/gWR6eqkVEur#case-report-forms", "label": "Master Services Agreement (Vivus Inc)", "score": 24.3483915127, "published": true}], "hash": "f489a5edc3a44c67c5e90fd056a424c3", "id": 9}, {"snippet": "Z \u00e1znamy subjektu hodnocen\u00ed.\n(a) (a) The Physician shall record all data on the electronic case report form provided by or on behalf of Biogen (the \u201cCRF\u201d). The original CRF shall be intended for Biogen\u2019s files and a copy of the same for retention in the Physician's files. Following delivery of the final CRF by the Physician, any changes to the database shall be made via a clarification form provided by Biogen or by CRO appointed by Biogen in relation to the Study. Ve\u0161ker\u00e1 data bude L\u00e9ka\u0159 zaznamen\u00e1vat do elektronick\u00e9ho formul\u00e1\u0159e pro z\u00e1znamy o subjektech hodnocen\u00ed, kter\u00fd/kter\u00e9 obdr\u017e\u00ed od spole\u010dnosti Biogen nebo jej\u00edm jm\u00e9nem (d\u00e1le jen \u201eformul\u00e1\u0159 CRF\u201d). Origin\u00e1l formul\u00e1\u0159e CRF bude ur\u010den pro spole\u010dnost Biogen, kopie formul\u00e1\u0159e bude ulo\u017eena do z\u00e1znam\u016f L\u00e9ka\u0159e. Pot\u00e9, co L\u00e9ka\u0159 p\u0159edlo\u017e\u00ed z\u00e1v\u011bre\u010dn\u00fd formul\u00e1\u0159 CRF, budou p\u0159\u00edpadn\u00e9 zm\u011bny v datab\u00e1zi prov\u00e1d\u011bny prost\u0159ednictv\u00edm formul\u00e1\u0159e pro up\u0159esn\u011bn\u00ed nebo vysv\u011btlen\u00ed \u00fadaj\u016f, kter\u00fd obdr\u017e\u00ed od spole\u010dnosti Biogen nebo od CRO pov\u011b\u0159en\u00e9 spole\u010dnost\u00ed Biogen v souvislosti se Studi\u00ed.\n(b) (b) CRFs that are submitted after the closure of Study enrollment will not be considered, and no compensation with respect to such CRFs shall be provided. Formul\u00e1\u0159e CRF odevzdan\u00e9 po uzav\u0159en\u00ed Studie nebudou br\u00e1ny v \u00favahu a za takov\u00e9 formul\u00e1\u0159e CRF nebude ani vyplacena odm\u011bna.\n(c) CRFs are to be entered into the Electronic Data Capture (eDC) by the Physician and/or Staff, within five (5) (c) Formul\u00e1\u0159e CRF budou L\u00e9ka\u0159 nebo Person\u00e1l zad\u00e1vat do elektronick\u00e9ho eviden\u010dn\u00edho syst\u00e9mu (eDC) do p\u011bti (5) business days of the patient standard of care visit date. pracovn\u00edch dn\u016f po datu pacientovy n\u00e1v\u0161t\u011bvy k proveden\u00ed b\u011b\u017en\u00fdch vy\u0161et\u0159en\u00ed.\n(d) Data queries are to be answered by the Physician and/or Staff within five (5) business days of assignment from Biogen and/or CRO.", "snippet_links": [{"key": "the-electronic", "type": "clause", "offset": [76, 90]}, {"key": "case-report-form", "type": "definition", "offset": [91, 107]}, {"key": "by-or-on-behalf-of", "type": "definition", "offset": [117, 135]}, {"key": "the-original", "type": "definition", "offset": [156, 168]}, {"key": "a-copy-of-the", "type": "clause", "offset": [214, 227]}, {"key": "the-final", "type": "clause", "offset": [295, 304]}, {"key": "the-database", "type": "definition", "offset": [342, 354]}, {"key": "a-clarification", "type": "clause", "offset": [373, 388]}, {"key": "by-biogen", "type": "clause", "offset": [403, 412]}, {"key": "by-cro", "type": "clause", "offset": [416, 422]}, {"key": "in-relation-to", "type": "clause", "offset": [443, 457]}, {"key": "the-study", "type": "definition", "offset": [458, 467]}, {"key": "study-enrollment", "type": "clause", "offset": [1067, 1083]}, {"key": "no-compensation", "type": "clause", "offset": [1112, 1127]}, {"key": "with-respect-to", "type": "clause", "offset": [1128, 1143]}, {"key": "entered-into", "type": "clause", "offset": [1312, 1324]}, {"key": "electronic-data-capture", "type": "clause", "offset": [1329, 1352]}, {"key": "business-days-of", "type": "clause", "offset": [1514, 1530]}, {"key": "standard-of-care", "type": "definition", "offset": [1543, 1559]}, {"key": "visit-date", "type": "definition", "offset": [1560, 1570]}, {"key": "data-queries", "type": "clause", "offset": [1650, 1662]}], "size": 2, "samples": [{"hash": "75VOvChLXeh", "uri": "/contracts/75VOvChLXeh#case-report-forms", "label": "Observational Study Agreement", "score": 24.3867214237, "published": true}], "hash": "0140ba3f3522d3b1eab40c5654b1fef9", "id": 10}], "next_curs": "CloSVGoVc35sYXdpbnNpZGVyY29udHJhY3RzcjYLEhZDbGF1c2VTbmlwcGV0R3JvdXBfdjU2IhpjYXNlLXJlcG9ydC1mb3JtcyMwMDAwMDAwYQyiAQJlbhgAIAA=", "clause": {"children": [["telephone", "Telephone"]], "title": "Case Report Forms", "size": 63, "parents": [["study-data", "Study Data"], ["miscellaneous-provisions", "Miscellaneous Provisions"], ["execution-in-counterparts-facsimile-signatures", "Execution in Counterparts; Facsimile Signatures"], ["concomitant-medication", "Concomitant medication"], ["duration-of-the-study", "Duration of the study"]], "id": "case-report-forms", "related": [["grievance-report-form", "GRIEVANCE REPORT FORM", "GRIEVANCE REPORT FORM"], ["report-submission", "REPORT SUBMISSION", "REPORT SUBMISSION"], ["compliance-statement", "Compliance Statement", "Compliance Statement"], ["payment-reports", "Payment; Reports", "Payment; Reports"], ["implementation-report", "Implementation Report", "Implementation Report"]], "related_snippets": [], "updated": "2025-07-07T16:38:45+00:00"}, "json": true, "cursor": ""}}