{"component": "clause", "props": {"groups": [{"snippet": "1.6 Z\u00e1znamy subjektu hodnocen\u00ed a Studijn\u00ed \u00fadaje\na) The Sponsor shall supply (or if electronic, provide access to) the forms to be used and completed by the Investigator to document a Study subject\u2019s participation in the Study (the \u201cCase Report Forms\u201d or \u201cCRFs\u201d). The Investigator shall record all data generated as a result of conducting the Study (the \u201cStudy Data\u201d) in a timely, accurate and complete manner, and shall ensure that the Case Report Forms for each Study subject are duly signed and dated. To the extent the Study requires completion of electronic Case Report Forms, the Institution and the Investigator shall ensure that they have implemented and maintain appropriate computer security sufficient to protect the confidentiality, integrity and availability of such Study Data in accordance with the Applicable Regulatory Requirements. The Investigator shall not grant unauthorized users access to the electronic data capture (EDC) system used in the Study, and in particular, shall not share or disclose his/her username and/or passwords.\na) Zadavatel dod\u00e1 formul\u00e1\u0159e (pokud se jedn\u00e1 o elektronickou formu, ud\u011bl\u00ed p\u0159\u00edstup), kter\u00e9 Hlavn\u00ed zkou\u0161ej\u00edc\u00ed pou\u017eije a vypln\u00ed pro zdokumentov\u00e1n\u00ed \u00fa\u010dasti Subjekt\u016f hodnocen\u00ed ve Studii (d\u00e1le jen \u201eZ\u00e1znamy subjektu hodnocen\u00ed\u201c nebo \u201eCRFs\u201c). Hlavn\u00ed zkou\u0161ej\u00edc\u00ed bude zaznamen\u00e1vat ve\u0161ker\u00e9 \u00fadaje z\u00edskan\u00e9 v pr\u016fb\u011bhu prov\u00e1d\u011bn\u00ed Studie (d\u00e1le jen \u201eStudijn\u00ed \u00fadaje\u201c) v\u010das, p\u0159esn\u011b a \u00fapln\u011b do formul\u00e1\u0159e a zajist\u00ed, aby ve\u0161ker\u00e9 Z\u00e1znamy subjektu hodnocen\u00ed byly n\u00e1le\u017eit\u011b podeps\u00e1ny a datov\u00e1ny. V rozsahu, v jak\u00e9m Studie vy\u017eaduje vypl\u0148ov\u00e1n\u00ed elektronick\u00fdch Z\u00e1znam\u016f subjekt\u016f hodnocen\u00ed, zajist\u00ed Zdravotnick\u00e9 za\u0159\u00edzen\u00ed a Hlavn\u00ed zkou\u0161ej\u00edc\u00ed p\u0159im\u011b\u0159en\u00e9 zabezpe\u010den\u00ed po\u010d\u00edta\u010de posta\u010duj\u00edc\u00ed k ochran\u011b d\u016fv\u011brnosti, neporu\u0161enosti a dostupnosti t\u011bchto \u00fadaj\u016f v souladu s Platn\u00fdmi regula\u010dn\u00edmi po\u017eadavky. Hlavn\u00ed zkou\u0161ej\u00edc\u00ed nebude ud\u011blovat p\u0159\u00edstup do syst\u00e9mu elektronick\u00e9ho zaznamen\u00e1v\u00e1n\u00ed \u00fadaj\u016f (EDC) pou\u017e\u00edvan\u00e9ho ve Studii neopr\u00e1vn\u011bn\u00fdm osob\u00e1m a zejm\u00e9na pak nebude sd\u011blovat sv\u00e9 u\u017eivatelsk\u00e9 jm\u00e9no a/nebo heslo.\nb) The Institution and the Investigator shall take reasonable and customary precautions to prevent the loss or alteration of any Study Data. The Institution and the Investigator acknowledge and agree that the Sponsor shall own all Study Data.\nb) Zdravotnick\u00e9 za\u0159\u00edzen\u00ed a Hlavn\u00ed zkou\u0161ej\u00edc\u00ed u\u010din\u00ed odpov\u00eddaj\u00edc\u00ed opat\u0159en\u00ed, aby nedo\u0161lo ke ztr\u00e1t\u011b nebo zm\u011bn\u011b \u017e\u00e1dn\u00fdch Studijn\u00edch \u00fadaj\u016f. Zdravotnick\u00e9 za\u0159\u00edzen\u00ed a Hlavn\u00ed zkou\u0161ej\u00edc\u00ed uzn\u00e1vaj\u00ed a souhlas\u00ed, \u017ee Zadavatel je vlastn\u00edkem ve\u0161ker\u00fdch Studijn\u00edch \u00fadaj\u016f.", "size": 15, "snippet_links": [{"key": "z\u00e1znamy-subjektu-hodnocen\u00ed", "type": "clause", "offset": [4, 30]}, {"key": "the-sponsor", "type": "clause", "offset": [51, 62]}, {"key": "provide-access", "type": "clause", "offset": [95, 109]}, {"key": "completed-by", "type": "clause", "offset": [139, 151]}, {"key": "the-investigator", "type": "clause", "offset": [152, 168]}, {"key": "study-subject", "type": "clause", "offset": [183, 196]}, {"key": "in-the-study", "type": "clause", "offset": [213, 225]}, {"key": "case-report-forms", "type": "definition", "offset": [232, 249]}, {"key": "study-data", "type": "clause", "offset": [354, 364]}, {"key": "accurate-and-complete", "type": "clause", "offset": [380, 401]}, {"key": "the-case", "type": "definition", "offset": [432, 440]}, {"key": "signed-and-dated", "type": "clause", "offset": [486, 502]}, {"key": "to-the-extent", "type": "clause", "offset": [504, 517]}, {"key": "completion-of", "type": "clause", "offset": [537, 550]}, {"key": "the-institution", "type": "clause", "offset": [581, 596]}, {"key": "computer-security", "type": "clause", "offset": [683, 700]}, {"key": "availability-of", "type": "clause", "offset": [758, 773]}, {"key": "in-accordance-with", "type": "clause", "offset": [790, 808]}, {"key": "applicable-regulatory-requirements", "type": "definition", "offset": [813, 847]}, {"key": "unauthorized-users", "type": "clause", "offset": [882, 900]}, {"key": "electronic-data-capture", "type": "clause", "offset": [915, 938]}, {"key": "in-particular", "type": "clause", "offset": [975, 988]}, {"key": "hlavn\u00ed-zkou\u0161ej\u00edc\u00ed", "type": "clause", "offset": [1142, 1159]}, {"key": "prov\u00e1d\u011bn\u00ed-studie", "type": "clause", "offset": [1353, 1369]}, {"key": "zdravotnick\u00e9-za\u0159\u00edzen\u00ed-a", "type": "clause", "offset": [1615, 1638]}, {"key": "reasonable-and-customary", "type": "clause", "offset": [2060, 2084]}, {"key": "acknowledge-and-agree", "type": "clause", "offset": [2187, 2208]}], "samples": [{"hash": "1HIEDwLToZA", "uri": "/contracts/1HIEDwLToZA#case-report-forms-and-study-data", "label": "Clinical Study Agreement", "score": 24.7175006866, "published": true}, {"hash": "3KksWYNjSV2", "uri": "/contracts/3KksWYNjSV2#case-report-forms-and-study-data", "label": "Clinical Study Agreement", "score": 23.4715938568, "published": true}], "hash": "e938f23b059f44acf5ab8e8198f93462", "id": 1}, {"snippet": "a) PSI shall supply (or if electronic, provide access to) the forms to be used and completed by the Investigator to document a Study subject\u2019s participation in the Study (the \u201cCase Report Forms\u201d or \u201cCRFs\u201d). The Investigator shall record all data generated as a result of conducting the Study (the \u201cStudy Data\u201d) within 5 business days, in an accurate and complete manner, and shall ensure that the Case Report Forms for each Study subject are duly signed and dated. To the extent the Study requires completion of electronic Case Report Forms, the Institution and the Investigator shall ensure that they have implemented and maintain appropriate computer security sufficient to protect the confidentiality, integrity and availability of such Study Data in accordance with the Applicable Regulatory Requirements. The Investigator shall not grant unauthorized users access to the electronic data capture (EDC) system used in the Study, and in particular, shall not share or disclose his/her username and/or passwords.\nb) The Institution and the Investigator shall take reasonable and customary precautions to prevent the loss or alteration of any Study Data.\na) Hlavn\u00ed zkou\u0161ej\u00edc\u00ed v souladu se v\u0161emi Platn\u00fdmi regula\u010dn\u00edmi po\u017eadavky z\u00edsk\u00e1 od v\u0161ech Subjekt\u016f hodnocen\u00ed nebo jejich z\u00e1stupc\u016f \u0159\u00e1dn\u011b podepsan\u00fd informovan\u00fd souhlas, a to p\u0159ed zah\u00e1jen\u00edm \u00fa\u010dasti subjektu ve studii.\nb) Hlavn\u00ed zkou\u0161ej\u00edc\u00ed bude pou\u017e\u00edvat formul\u00e1\u0159 informovan\u00e9ho souhlasu (d\u00e1le jen \u201eFormul\u00e1\u0159 informovan\u00e9ho souhlasu\u201c) poskytnut\u00fd PSI a schv\u00e1len\u00fd v souladu se v\u0161emi Platn\u00fdmi regula\u010dn\u00edmi po\u017eadavky.", "size": 5, "snippet_links": [{"key": "provide-access", "type": "clause", "offset": [39, 53]}, {"key": "completed-by", "type": "clause", "offset": [83, 95]}, {"key": "the-investigator", "type": "clause", "offset": [96, 112]}, {"key": "study-subject", "type": "clause", "offset": [127, 140]}, {"key": "in-the-study", "type": "clause", "offset": [157, 169]}, {"key": "case-report-forms", "type": "definition", "offset": [176, 193]}, {"key": "study-data", "type": "clause", "offset": [298, 308]}, {"key": "business-days", "type": "clause", "offset": [320, 333]}, {"key": "accurate-and-complete", "type": "clause", "offset": [341, 362]}, {"key": "the-case", "type": "definition", "offset": [393, 401]}, {"key": "signed-and-dated", "type": "clause", "offset": [447, 463]}, {"key": "to-the-extent", "type": "clause", "offset": [465, 478]}, {"key": "completion-of", "type": "clause", "offset": [498, 511]}, {"key": "the-institution", "type": "clause", "offset": [542, 557]}, {"key": "computer-security", "type": "clause", "offset": [644, 661]}, {"key": "availability-of", "type": "clause", "offset": [719, 734]}, {"key": "in-accordance-with", "type": "clause", "offset": [751, 769]}, {"key": "applicable-regulatory-requirements", "type": "definition", "offset": [774, 808]}, {"key": "unauthorized-users", "type": "clause", "offset": [843, 861]}, {"key": "electronic-data-capture", "type": "clause", "offset": [876, 899]}, {"key": "in-particular", "type": "clause", "offset": [936, 949]}, {"key": "reasonable-and-customary", "type": "clause", "offset": [1065, 1089]}, {"key": "hlavn\u00ed-zkou\u0161ej\u00edc\u00ed", "type": "clause", "offset": [1158, 1175]}, {"key": "informovan\u00fd-souhlas", "type": "clause", "offset": [1297, 1316]}, {"key": "formul\u00e1\u0159-informovan\u00e9ho-souhlasu", "type": "clause", "offset": [1400, 1431]}], "samples": [{"hash": "d0TuFSmzHfh", "uri": "/contracts/d0TuFSmzHfh#case-report-forms-and-study-data", "label": "Clinical Study Agreement", "score": 26.5446071625, "published": true}], "hash": "3eab0924f7e5d6ea8c938499f1f59eda", "id": 2}, {"snippet": "a) PSI shall provide access to the electronic Case Report Forms to be used and completed by the Investigator to document a Study subject\u2019s participation in the Study (the \u201cCase Report Forms\u201d or \u201cCRFs\u201d). The Investigator shall record all data generated as a result of conducting the Study (the \u201cStudy Data\u201d) in a timely, true, correct, accurate and complete manner in source documents as defined by ICH GCP, and shall ensure that the Case Report Forms for each Study subject are duly signed and dated. The Institution and the Investigator will be responsible for data entry. Where specifically required for Data Adjudication Committee, data entry should occur within two (2) days of a subject visit. Otherwise data entry should occur within five (5) days of a subject visit. Study Personnel will be expected to respond to any electronic data queries within seven (7) days of their creation.\na) Hlavn\u00ed zkou\u0161ej\u00edc\u00ed v souladu se v\u0161emi Platn\u00fdmi regula\u010dn\u00edmi po\u017eadavky z\u00edsk\u00e1 od v\u0161ech Subjekt\u016f hodnocen\u00ed nebo jejich z\u00e1stupc\u016f \u0159\u00e1dn\u011b podepsan\u00fd informovan\u00fd souhlas schv\u00e1len\u00fd EC/IRB, a to p\u0159ed zah\u00e1jen\u00edm \u00fa\u010dasti Subjektu hodnocen\u00ed ve Studii.\nb) Hlavn\u00ed zkou\u0161ej\u00edc\u00ed bude pou\u017e\u00edvat formul\u00e1\u0159 informovan\u00e9ho souhlasu (d\u00e1le jen \u201eFormul\u00e1\u0159 informovan\u00e9ho souhlasu\u201c) poskytnut\u00fd PSI a schv\u00e1len\u00fd v souladu se v\u0161emi Platn\u00fdmi regula\u010dn\u00edmi po\u017eadavky.", "size": 4, "snippet_links": [{"key": "the-electronic", "type": "clause", "offset": [31, 45]}, {"key": "case-report-forms", "type": "definition", "offset": [46, 63]}, {"key": "completed-by", "type": "clause", "offset": [79, 91]}, {"key": "the-investigator", "type": "clause", "offset": [92, 108]}, {"key": "study-subject", "type": "clause", "offset": [123, 136]}, {"key": "in-the-study", "type": "clause", "offset": [153, 165]}, {"key": "study-data", "type": "clause", "offset": [294, 304]}, {"key": "accurate-and-complete", "type": "clause", "offset": [335, 356]}, {"key": "source-documents", "type": "definition", "offset": [367, 383]}, {"key": "ich-gcp", "type": "definition", "offset": [398, 405]}, {"key": "the-case", "type": "definition", "offset": [429, 437]}, {"key": "signed-and-dated", "type": "clause", "offset": [483, 499]}, {"key": "the-institution", "type": "clause", "offset": [501, 516]}, {"key": "responsible-for", "type": "clause", "offset": [546, 561]}, {"key": "data-entry", "type": "clause", "offset": [562, 572]}, {"key": "adjudication-committee", "type": "definition", "offset": [611, 633]}, {"key": "study-personnel", "type": "definition", "offset": [774, 789]}, {"key": "respond-to", "type": "definition", "offset": [810, 820]}, {"key": "data-queries", "type": "clause", "offset": [836, 848]}, {"key": "hlavn\u00ed-zkou\u0161ej\u00edc\u00ed", "type": "clause", "offset": [893, 910]}, {"key": "informovan\u00fd-souhlas", "type": "clause", "offset": [1032, 1051]}, {"key": "formul\u00e1\u0159-informovan\u00e9ho-souhlasu", "type": "clause", "offset": [1162, 1193]}], "samples": [{"hash": "43YGrSgf1nR", "uri": "/contracts/43YGrSgf1nR#case-report-forms-and-study-data", "label": "Clinical Study Agreement", "score": 30.313539505, "published": true}], "hash": "a3416a886c924c1fd0d9e4a87715565c", "id": 3}, {"snippet": "a) The Investigator shall record all data resulting from the Study (the \u201cStudy Data\u201d) in an accurate, legible and complete manner. The Institution acknowledges and agrees that the Sponsor shall own all Study Data and Study results.\nb) The Sponsor shall ensure access to the electronic case report forms to be used and completed by the Investigator (the \u201cCRFs\u201d). The Investigator shall ensure that the CRFs are duly completed, signed and dated in a timely manner\nc) The Institution shall ensure that it has implemented and maintains appropriate measures to protect the confidentiality, integrity and availability of Study Data and to prevent the loss, alteration and unauthorized access.", "size": 3, "snippet_links": [{"key": "the-investigator", "type": "clause", "offset": [3, 19]}, {"key": "the-study", "type": "definition", "offset": [57, 66]}, {"key": "study-data", "type": "clause", "offset": [73, 83]}, {"key": "the-institution", "type": "clause", "offset": [131, 146]}, {"key": "the-sponsor", "type": "clause", "offset": [176, 187]}, {"key": "study-results", "type": "clause", "offset": [217, 230]}, {"key": "the-electronic", "type": "clause", "offset": [270, 284]}, {"key": "case-report-forms", "type": "definition", "offset": [285, 302]}, {"key": "completed-by", "type": "clause", "offset": [318, 330]}, {"key": "signed-and-dated", "type": "clause", "offset": [426, 442]}, {"key": "in-a-timely-manner", "type": "definition", "offset": [443, 461]}, {"key": "institution-shall", "type": "clause", "offset": [469, 486]}, {"key": "measures-to", "type": "clause", "offset": [544, 555]}, {"key": "availability-of", "type": "clause", "offset": [599, 614]}, {"key": "unauthorized-access", "type": "definition", "offset": [666, 685]}], "samples": [{"hash": "heGFufYrdpd", "uri": "/contracts/heGFufYrdpd#case-report-forms-and-study-data", "label": "Clinical Study Agreement", "score": 34.4459495544, "published": true}, {"hash": "akMOynEdooO", "uri": "/contracts/akMOynEdooO#case-report-forms-and-study-data", "label": "Clinical Study Agreement", "score": 32.518913269, "published": true}], "hash": "ccd684b5738f885340358feaeb1f6b40", "id": 4}, {"snippet": "a) PSI shall supply (or if electronic, provide access to) the forms to be used and completed by the Investigator to document a Study subject\u2019s participation in the Study (the \u201cCase Report Forms\u201d or \u201cCRFs\u201d). The Investigator shall record all data generated as a result of conducting the Study (the \u201cStudy Data\u201d) within 5 business days, in an accurate and complete manner, and shall ensure that the Case Report Forms for each Study subject are duly signed and dated. To the extent the Study requires completion of electronic Case Report Forms, the Institution and the Investigator shall ensure that they have implemented and maintain appropriate computer security sufficient to protect the confidentiality, integrity and availability of such Study Data in accordance with the Applicable Regulatory Requirements. The Investigator shall not grant unauthorized users access to the electronic data capture (EDC) system used in the Study, and in particular, shall not share or disclose his/her username and/or passwords.\nb) The Institution and the Investigator shall take reasonable and customary precautions to prevent the loss or alteration of any Study Data. The Institution and the Investigator acknowledge and agree that the Sponsor shall own all Study Data.", "size": 3, "snippet_links": [{"key": "provide-access", "type": "clause", "offset": [39, 53]}, {"key": "completed-by", "type": "clause", "offset": [83, 95]}, {"key": "the-investigator", "type": "clause", "offset": [96, 112]}, {"key": "study-subject", "type": "clause", "offset": [127, 140]}, {"key": "in-the-study", "type": "clause", "offset": [157, 169]}, {"key": "case-report-forms", "type": "definition", "offset": [176, 193]}, {"key": "study-data", "type": "clause", "offset": [298, 308]}, {"key": "business-days", "type": "clause", "offset": [320, 333]}, {"key": "accurate-and-complete", "type": "clause", "offset": [341, 362]}, {"key": "the-case", "type": "definition", "offset": [393, 401]}, {"key": "signed-and-dated", "type": "clause", "offset": [447, 463]}, {"key": "to-the-extent", "type": "clause", "offset": [465, 478]}, {"key": "completion-of", "type": "clause", "offset": [498, 511]}, {"key": "the-institution", "type": "clause", "offset": [542, 557]}, {"key": "computer-security", "type": "clause", "offset": [644, 661]}, {"key": "availability-of", "type": "clause", "offset": [719, 734]}, {"key": "in-accordance-with", "type": "clause", "offset": [751, 769]}, {"key": "applicable-regulatory-requirements", "type": "definition", "offset": [774, 808]}, {"key": "unauthorized-users", "type": "clause", "offset": [843, 861]}, {"key": "electronic-data-capture", "type": "clause", "offset": [876, 899]}, {"key": "in-particular", "type": "clause", "offset": [936, 949]}, {"key": "reasonable-and-customary", "type": "clause", "offset": [1065, 1089]}, {"key": "acknowledge-and-agree", "type": "clause", "offset": [1192, 1213]}, {"key": "the-sponsor", "type": "clause", "offset": [1219, 1230]}], "samples": [{"hash": "gfdlKEDuvKn", "uri": "/contracts/gfdlKEDuvKn#case-report-forms-and-study-data", "label": "Clinical Study Agreement", "score": 27.5378494263, "published": true}], "hash": "12785d7e0722f34133ed2448559c89d0", "id": 5}, {"snippet": "Z\u00e1znamy subjektu hodnocen\u00ed a Studijn\u00ed \u00fadaje", "size": 2, "snippet_links": [{"key": "z\u00e1znamy-subjektu-hodnocen\u00ed", "type": "clause", "offset": [0, 26]}], "samples": [{"hash": "h6CPWmEsawQ", "uri": "/contracts/h6CPWmEsawQ#case-report-forms-and-study-data", "label": "Clinical Study Agreement", "score": 29.573972702, "published": true}, {"hash": "fPGvEOy9NvG", "uri": "/contracts/fPGvEOy9NvG#case-report-forms-and-study-data", "label": "Clinical Study Agreement", "score": 28.9074897766, "published": true}], "hash": "a3637e4d65f87261b0b3794e954f0eb8", "id": 6}, {"snippet": "a) PSI shall supply (or if electronic, provide access to) the forms to be used and completed by the Investigator to document a Study subject\u2019s participation in the Study (the \u201cCase Report Forms\u201d or \u201cCRFs\u201d). The Investigator shall record all data generated as a result of conducting the Study (the \u201cStudy Data\u201d) within 5 business days after the data has been generated, in an accurate and complete manner, and shall ensure that the Case Report Forms for\na) Hlavn\u00ed zkou\u0161ej\u00edc\u00ed v souladu se v\u0161emi Platn\u00fdmi regula\u010dn\u00edmi po\u017eadavky z\u00edsk\u00e1 od v\u0161ech Subjekt\u016f hodnocen\u00ed nebo jejich z\u00e1stupc\u016f \u0159\u00e1dn\u011b podepsan\u00fd informovan\u00fd souhlas, a to p\u0159ed zah\u00e1jen\u00edm \u00fa\u010dasti subjektu ve studii.\nb) Hlavn\u00ed zkou\u0161ej\u00edc\u00ed bude pou\u017e\u00edvat formul\u00e1\u0159 informovan\u00e9ho souhlasu (d\u00e1le jen \u201eFormul\u00e1\u0159 informovan\u00e9ho souhlasu\u201c) poskytnut\u00fd PSI a schv\u00e1len\u00fd v souladu se v\u0161emi Platn\u00fdmi regula\u010dn\u00edmi po\u017eadavky.", "size": 2, "snippet_links": [{"key": "access-to", "type": "definition", "offset": [47, 56]}, {"key": "completed-by", "type": "clause", "offset": [83, 95]}, {"key": "the-investigator", "type": "clause", "offset": [96, 112]}, {"key": "study-subject", "type": "clause", "offset": [127, 140]}, {"key": "in-the-study", "type": "clause", "offset": [157, 169]}, {"key": "case-report-forms", "type": "definition", "offset": [176, 193]}, {"key": "study-data", "type": "clause", "offset": [298, 308]}, {"key": "days-after", "type": "definition", "offset": [329, 339]}, {"key": "the-data", "type": "clause", "offset": [340, 348]}, {"key": "accurate-and-complete", "type": "clause", "offset": [375, 396]}, {"key": "the-case", "type": "definition", "offset": [427, 435]}, {"key": "hlavn\u00ed-zkou\u0161ej\u00edc\u00ed", "type": "clause", "offset": [456, 473]}, {"key": "informovan\u00fd-souhlas", "type": "clause", "offset": [595, 614]}, {"key": "formul\u00e1\u0159-informovan\u00e9ho-souhlasu", "type": "clause", "offset": [698, 729]}], "samples": [{"hash": "h4CV5SBjUeD", "uri": "/contracts/h4CV5SBjUeD#case-report-forms-and-study-data", "label": "Clinical Study Agreement", "score": 30.5438098907, "published": true}], "hash": "a403c75d1afa1f8bd717e31e83e9d389", "id": 7}, {"snippet": "(a) PSI shall supply to the Investigative Site forms to be used and completed by the Investigator to document a Study Subject\u2019s participation in the Study (such forms are referred to as \u201cElectronic Case Report Forms\u201d). 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