{"component": "clause", "props": {"groups": [{"snippet_links": [{"key": "in-the-event", "type": "clause", "offset": [0, 12]}, {"key": "future-modifications", "type": "definition", "offset": [13, 33]}, {"key": "the-protocol", "type": "clause", "offset": [37, 49]}, {"key": "the-approval", "type": "clause", "offset": [103, 115]}, {"key": "study-site", "type": "definition", "offset": [220, 230]}, {"key": "the-cost", "type": "clause", "offset": [285, 293]}, {"key": "written-estimate", "type": "clause", "offset": [334, 350]}, {"key": "for-approval", "type": "definition", "offset": [358, 370]}, {"key": "notwithstanding-the-foregoing", "type": "clause", "offset": [372, 401]}, {"key": "in-the-course-of", "type": "definition", "offset": [403, 419]}, {"key": "based-on", "type": "clause", "offset": [486, 494]}, {"key": "studijn\u00ed-pracovi\u0161t\u011b", "type": "clause", "offset": [852, 871]}, {"key": "accepted-standards", "type": "definition", "offset": [987, 1005]}, {"key": "clinical-research", "type": "clause", "offset": [1009, 1026]}, {"key": "medical-practice", "type": "definition", "offset": [1031, 1047]}, {"key": "relating-to", "type": "definition", "offset": [1048, 1059]}, {"key": "the-benefit", "type": "definition", "offset": [1060, 1071]}, {"key": "and-safety", "type": "clause", "offset": [1085, 1095]}, {"key": "in-writing", "type": "clause", "offset": [1149, 1159]}, {"key": "prior-to", "type": "definition", "offset": [1160, 1168]}, {"key": "emergency-situations", "type": "definition", "offset": [1204, 1224]}, {"key": "prov\u00e1d\u011bn\u00ed-studie", "type": "clause", "offset": [1268, 1284]}], "samples": [{"hash": "HXp2ePH3Ty", "uri": "/contracts/HXp2ePH3Ty#protocol-modifications", "label": "Clinical Study Agreement", "score": 21.6878850103, "published": true}], "snippet": "In the event future modifications in the Protocol appear desirable, such changes may be made only with the approval of DSI, which shall have sole overriding discretion in such matters, and the subsequent approval of the Study Site\u2019s EC. If such modifications can be expected to affect the cost for the Study, Study Site will submit a written estimate to DSI for approval. Notwithstanding the foregoing, in the course of performing the Study, if deviation from the Protocol is necessary based on generally 5. Zm\u011bny protokolu. V p\u0159\u00edpad\u011b, \u017ee v budoucnu vyvstane pot\u0159eba zm\u011bn v protokolu, je mo\u017eno takov\u00e9 zm\u011bny prov\u00e9st pouze se souhlasem spole\u010dnosti DSI, kter\u00e1 bude m\u00edt v t\u011bchto z\u00e1le\u017eitostech pr\u00e1vo kone\u010dn\u00e9ho rozhodnut\u00ed, a na z\u00e1klad\u011b n\u00e1sledn\u00e9ho schv\u00e1len\u00ed EK studijn\u00edho pracovi\u0161t\u011b. Pokud lze o\u010dek\u00e1vat, \u017ee takov\u00e9 zm\u011bny negativn\u011b ovlivn\u00ed n\u00e1klady t\u00e9to studie, studijn\u00ed pracovi\u0161t\u011b p\u0159edlo\u017e\u00ed spole\u010dnosti DSI ke schv\u00e1len\u00ed p\u00edsemn\u00fd odhad n\u00e1klad\u016f. Nehled\u011b na p\u0159edch\u00e1zej\u00edc\u00ed ujedn\u00e1n\u00ed, pokud se v pr\u016fb\u011bhu accepted standards of clinical research and medical practice relating to the benefit, well- being and safety of patients, the Study Site shall notify DSI and CRO in writing prior to implementing such deviation, or in emergency situations, within twenty-four (24) hours thereafter. prov\u00e1d\u011bn\u00ed studie uk\u00e1\u017ee, \u017ee je nutn\u00e1 odchylka od protokolu na z\u00e1klad\u011b v\u0161eobecn\u011b uzn\u00e1van\u00fdch \u2587\u2587\u2587\u2587\u2587 klinick\u00e9ho v\u00fdzkumu a l\u00e9ka\u0159sk\u00e9 praxe vztahuj\u00edc\u00ed se k prosp\u011bchu, zdrav\u00ed a bezpe\u010dnosti pacient\u016f, studijn\u00ed pracovi\u0161t\u011b p\u00edsemn\u011b vyrozum\u00ed spole\u010dnost DSI a CRO p\u0159ed proveden\u00edm uveden\u00e9 odchylky nebo v nal\u00e9hav\u00fdch p\u0159\u00edpadech do dvaceti \u010dty\u0159 (24) hodin pot\u00e9.", "size": 9, "hash": "078e0547c33dd55e6776dd3965dce3fa", "id": 1}, {"snippet_links": [{"key": "in-the-event", "type": "clause", "offset": [0, 12]}, {"key": "future-modifications", "type": "definition", "offset": [13, 33]}, {"key": "the-protocol", "type": "clause", "offset": [37, 49]}, {"key": "the-approval", "type": "clause", "offset": [103, 115]}, {"key": "study-site", "type": "definition", "offset": [220, 230]}, {"key": "the-cost", "type": "clause", "offset": [285, 293]}, {"key": "written-estimate", "type": "clause", "offset": [334, 350]}, {"key": "for-approval", "type": "definition", "offset": [358, 370]}, {"key": "notwithstanding-the-foregoing", "type": "clause", "offset": [372, 401]}, {"key": "in-the-course-of", "type": "definition", "offset": [403, 419]}, {"key": "based-on", "type": "clause", "offset": [486, 494]}, {"key": "accepted-standards", "type": "definition", "offset": [505, 523]}, {"key": "clinical-research", "type": "clause", "offset": [527, 544]}, {"key": "medical-practice", "type": "definition", "offset": [549, 565]}, {"key": "relating-to", "type": "definition", "offset": [566, 577]}, {"key": "the-benefit", "type": "definition", "offset": [578, 589]}, {"key": "and-safety", "type": "clause", "offset": [603, 613]}, {"key": "in-writing", "type": "clause", "offset": [667, 677]}, {"key": "prior-to", "type": "definition", "offset": [678, 686]}, {"key": "emergency-situations", "type": "definition", "offset": [722, 742]}], "samples": [{"hash": "lL9a4qNbGMt", "uri": "/contracts/lL9a4qNbGMt#protocol-modifications", "label": "Clinical Study Agreement", "score": 32.2425235195, "published": true}, {"hash": "54D04lRsJxx", "uri": "/contracts/54D04lRsJxx#protocol-modifications", "label": "Clinical Study Agreement", "score": 25.2622361901, "published": true}, {"hash": "eFbOHms6nSx", "uri": "/contracts/eFbOHms6nSx#protocol-modifications", "label": "Clinical Study Agreement", "score": 25.2430746171, "published": true}], "snippet": "In the event future modifications in the Protocol appear desirable, such changes may be made only with the approval of DSI, which shall have sole overriding discretion in such matters, and the subsequent approval of the Study Site\u2019s EC. If such modifications can be expected to affect the cost for the Study, Study Site will submit a written estimate to DSI for approval. Notwithstanding the foregoing, in the course of performing the Study, if deviation from the Protocol is necessary based on generally accepted standards of clinical research and medical practice relating to the benefit, well- being and safety of patients, the Study Site shall notify DSI and CRO in writing prior to implementing such deviation, or in emergency situations, within twenty-four (24) hours thereafter.", "size": 8, "hash": "cd39fadf6ae5324763de897205dc98d3", "id": 2}, {"snippet_links": [{"key": "by-the-parties", "type": "clause", "offset": [17, 31]}, {"key": "a-phase", "type": "definition", "offset": [59, 66]}, {"key": "from-time-to-time", "type": "clause", "offset": [89, 106]}, {"key": "subject-to-change", "type": "clause", "offset": [111, 128]}, {"key": "by-mutual-agreement", "type": "clause", "offset": [159, 178]}, {"key": "of-both-parties", "type": "clause", "offset": [207, 222]}], "samples": [{"hash": "jDaQO18DigU", "uri": "/contracts/jDaQO18DigU#protocol-modifications", "label": "Collaborative Research Agreement (Xenogen Corp)", "score": 21.0, "published": true}, {"hash": "46zsq8NgJcE", "uri": "/contracts/46zsq8NgJcE#protocol-modifications", "label": "Collaborative Research Agreement (Xenogen Corp)", "score": 21.0, "published": true}], "snippet": "It is understood by the Parties that their obligations for a Phase described herein may, from time to time, be subject to change at the direction of Pfizer or by mutual agreement of the principle scientists of both Parties.", "size": 4, "hash": "db6068277225461d0e097fa7fcb4cbc9", "id": 3}, {"snippet_links": [{"key": "in-the-event", "type": "clause", "offset": [0, 12]}, {"key": "future-modifications", "type": "definition", "offset": [13, 33]}, {"key": "the-protocol", "type": "clause", "offset": [37, 49]}, {"key": "the-approval", "type": "clause", "offset": [103, 115]}, {"key": "study-site", "type": "definition", "offset": [220, 230]}, {"key": "notwithstanding-the-foregoing", "type": "clause", "offset": [237, 266]}, {"key": "in-the-course-of", "type": "definition", "offset": [268, 284]}, {"key": "based-on", "type": "clause", "offset": [351, 359]}, {"key": "accepted-standards", "type": "definition", "offset": [370, 388]}, {"key": "clinical-research", "type": "clause", "offset": [392, 409]}, {"key": "medical-practice", "type": "definition", "offset": [414, 430]}, {"key": "relating-to", "type": "definition", "offset": [431, 442]}, {"key": "the-benefit", "type": "definition", "offset": [443, 454]}, {"key": "and-safety", "type": "clause", "offset": [468, 478]}, {"key": "in-writing", "type": "clause", "offset": [532, 542]}, {"key": "prior-to", "type": "definition", "offset": [543, 551]}, {"key": "emergency-situations", "type": "definition", "offset": [587, 607]}], "samples": [{"hash": "3pcNOBkDzxT", "uri": "/contracts/3pcNOBkDzxT#protocol-modifications", "label": "Clinical Study Agreement", "score": 27.2358782154, "published": true}], "snippet": "In the event future modifications in the Protocol appear desirable, such changes may be made only with the approval of DSI, which shall have sole overriding discretion in such matters, and the subsequent approval of the Study Site\u2019s EC. Notwithstanding the foregoing, in the course of performing the Study, if deviation from the Protocol is necessary based on generally accepted standards of clinical research and medical practice relating to the benefit, well- being and safety of patients, the Study Site shall notify DSI and CRO in writing prior to implementing such deviation, or in emergency situations, within twenty-four (24) hours thereafter.", "size": 1, "hash": "a8d0225a054a1c03e68926a1feca4d1f", "id": 4}, {"snippet_links": [{"key": "in-the-event", "type": "clause", "offset": [0, 12]}, {"key": "future-modifications", "type": "definition", "offset": [13, 33]}, {"key": "the-protocol", "type": "clause", "offset": [37, 49]}, {"key": "the-approval", "type": "clause", "offset": [103, 115]}, {"key": "study-site", "type": "definition", "offset": [220, 230]}, {"key": "the-cost", "type": "clause", "offset": [285, 293]}, {"key": "written-estimate", "type": "clause", "offset": [334, 350]}, {"key": "for-approval", "type": "definition", "offset": [358, 370]}, {"key": "notwithstanding-the-foregoing", "type": "clause", "offset": [372, 401]}, {"key": "in-the-course-of", "type": "definition", "offset": [403, 419]}, {"key": "based-on", "type": "clause", "offset": [486, 494]}, {"key": "accepted-standards", "type": "definition", "offset": [505, 523]}, {"key": "clinical-research", "type": "clause", "offset": [527, 544]}, {"key": "studijn\u00ed-pracovi\u0161t\u011b", "type": "clause", "offset": [896, 915]}, {"key": "prov\u00e1d\u011bn\u00ed-studie", "type": "clause", "offset": [1031, 1047]}], "samples": [{"hash": "1mbrMmJ7QGq", "uri": "/contracts/1mbrMmJ7QGq#protocol-modifications", "label": "Clinical Study Agreement", "score": 27.3973829026, "published": true}], "snippet": "In the event future modifications in the Protocol appear desirable, such changes may be made only with the approval of DSI, which shall have sole overriding discretion in such matters, and the subsequent approval of the Study Site\u2019s EC. If such modifications can be expected to affect the cost for the Study, Study Site will submit a written estimate to DSI for approval. Notwithstanding the foregoing, in the course of performing the Study, if deviation from the Protocol is necessary based on generally accepted standards of clinical research and 5. Zm\u011bny protokolu. V p\u0159\u00edpad\u011b, \u017ee v budoucnu vyvstane pot\u0159eba zm\u011bn v protokolu, je mo\u017eno takov\u00e9 zm\u011bny prov\u00e9st pouze se souhlasem spole\u010dnosti DSI, kter\u00e1 bude m\u00edt v t\u011bchto z\u00e1le\u017eitostech pr\u00e1vo kone\u010dn\u00e9ho rozhodnut\u00ed, a na z\u00e1klad\u011b n\u00e1sledn\u00e9ho schv\u00e1len\u00ed EK studijn\u00edho pracovi\u0161t\u011b. Pokud lze o\u010dek\u00e1vat, \u017ee takov\u00e9 zm\u011bny negativn\u011b ovlivn\u00ed n\u00e1klady t\u00e9to studie, studijn\u00ed pracovi\u0161t\u011b p\u0159edlo\u017e\u00ed spole\u010dnosti DSI ke schv\u00e1len\u00ed p\u00edsemn\u00fd odhad n\u00e1klad\u016f. Nehled\u011b na p\u0159edch\u00e1zej\u00edc\u00ed ujedn\u00e1n\u00ed, pokud se v pr\u016fb\u011bhu prov\u00e1d\u011bn\u00ed studie uk\u00e1\u017ee, \u017ee je nutn\u00e1 odchylka od protokolu na z\u00e1klad\u011b", "size": 1, "hash": "18e4d9875bbd62806d283104832b38be", "id": 5}, {"snippet_links": [{"key": "the-investigator", "type": "clause", "offset": [8, 24]}, {"key": "the-sponsor-will", "type": "clause", "offset": [29, 45]}, {"key": "formal-amendment", "type": "definition", "offset": [77, 93]}, {"key": "protocol-amendments", "type": "clause", "offset": [99, 118]}, {"key": "issued-by", "type": "definition", "offset": [127, 136]}, {"key": "signed-and-dated", "type": "clause", "offset": [154, 170]}, {"key": "irb-approval", "type": "clause", "offset": [254, 266]}, {"key": "the-relevant", "type": "clause", "offset": [276, 288]}, {"key": "competent-authority", "type": "definition", "offset": [289, 308]}, {"key": "for-non", "type": "clause", "offset": [332, 339]}, {"key": "the-amendment", "type": "clause", "offset": [436, 449]}, {"key": "administrative-aspects", "type": "clause", "offset": [571, 593]}, {"key": "the-study", "type": "definition", "offset": [597, 606]}, {"key": "where-required", "type": "clause", "offset": [625, 639]}, {"key": "the-protocol", "type": "clause", "offset": [709, 721]}, {"key": "in-attendance", "type": "definition", "offset": [759, 772]}, {"key": "sponsor-representative", "type": "definition", "offset": [802, 824]}, {"key": "information-pages", "type": "clause", "offset": [858, 875]}, {"key": "in-all-cases", "type": "clause", "offset": [990, 1002]}, {"key": "as-soon-as-possible", "type": "definition", "offset": [1042, 1061]}, {"key": "to-discuss", "type": "definition", "offset": [1071, 1081]}, {"key": "the-situation", "type": "clause", "offset": [1082, 1095]}, {"key": "an-appropriate", "type": "clause", "offset": [1109, 1123]}, {"key": "course-of-action", "type": "definition", "offset": [1124, 1140]}, {"key": "the-data", "type": "clause", "offset": [1142, 1150]}, {"key": "source-documents", "type": "definition", "offset": [1246, 1262]}], "samples": [{"hash": "bTNvSTbQ3Ag", "uri": "/contracts/bTNvSTbQ3Ag#protocol-modifications", "label": "License Agreement (Oxygen Biotherapeutics, Inc.)", "score": 25.205338809, "published": true}], "snippet": "Neither the investigator nor the sponsor will modify this protocol without a formal amendment. All protocol amendments must be issued by the sponsor, and signed and dated by the investigator. Protocol amendments must not be implemented without prior IEC/IRB approval, or when the relevant competent authority has raised any grounds for non-acceptance, except when necessary to eliminate immediate hazards to the subjects, in which case the amendment must be promptly submitted to the IEC/IRB and relevant competent authority. When the change(s) involves only logistic or administrative aspects of the study, the IRB (and IEC where required) only needs to be notified. In situations requiring a departure from the protocol, the investigator or other physician in attendance will contact the appropriate sponsor representative by fax or telephone (see Contact Information pages provided separately). If possible, this contact will be made before implementing any departure from the protocol. In all cases, contact with the sponsor must be made as soon as possible in order to discuss the situation and agree on an appropriate course of action. The data recorded in the eCRF and source document will reflect any departure from the protocol, and the source documents will describe this departure and the circumstances requiring it.", "size": 1, "hash": "95a5e43a563dd665118ead31e439cdd2", "id": 6}, {"snippet_links": [{"key": "in-the-event", "type": "clause", "offset": [0, 12]}, {"key": "future-modifications", "type": "definition", "offset": [13, 33]}, {"key": "the-protocol", "type": "clause", "offset": [37, 49]}, {"key": "approval-of", "type": "clause", "offset": [107, 118]}, {"key": "subsequent-approval", "type": "definition", "offset": [197, 216]}, {"key": "of-the-provider", "type": "clause", "offset": [217, 232]}, {"key": "the-cost", "type": "clause", "offset": [287, 295]}, {"key": "the-study", "type": "definition", "offset": [300, 309]}, {"key": "written-estimate", "type": "clause", "offset": [361, 377]}, {"key": "for-approval", "type": "definition", "offset": [389, 401]}, {"key": "notwithstanding-the-foregoing", "type": "clause", "offset": [403, 432]}, {"key": "in-the-course-of", "type": "definition", "offset": [434, 450]}, {"key": "based-on", "type": "clause", "offset": [517, 525]}, {"key": "accepted-standards", "type": "definition", "offset": [536, 554]}, {"key": "clinical-research", "type": "clause", "offset": [558, 575]}, {"key": "medical-practice", "type": "definition", "offset": [580, 596]}, {"key": "relating-to", "type": "definition", "offset": [597, 608]}, {"key": "the-benefit", "type": "definition", "offset": [609, 620]}, {"key": "hlavn\u00ed-zkou\u0161ej\u00edc\u00ed", "type": "clause", "offset": [988, 1005]}, {"key": "prov\u00e1d\u011bn\u00ed-studie", "type": "clause", "offset": [1100, 1116]}, {"key": "the-provider-shall", "type": "clause", "offset": [1267, 1285]}, {"key": "in-writing", "type": "clause", "offset": [1309, 1319]}, {"key": "prior-to", "type": "definition", "offset": [1320, 1328]}, {"key": "emergency-situations", "type": "definition", "offset": [1364, 1384]}, {"key": "change-of", "type": "definition", "offset": [1432, 1441]}, {"key": "the-principal-investigator", "type": "clause", "offset": [1464, 1490]}, {"key": "obligations-under-this-agreement", "type": "clause", "offset": [1493, 1525]}, {"key": "in-particular", "type": "clause", "offset": [1538, 1551]}, {"key": "amendments-and-or-modifications", "type": "clause", "offset": [1557, 1588]}, {"key": "by-sponsor", "type": "clause", "offset": [1610, 1620]}, {"key": "amendment-to-the-agreement", "type": "clause", "offset": [1657, 1683]}, {"key": "by-the-parties", "type": "clause", "offset": [1689, 1703]}, {"key": "null-and-void", "type": "definition", "offset": [1721, 1734]}, {"key": "the-parties-shall", "type": "clause", "offset": [1736, 1753]}, {"key": "in-good-faith", "type": "definition", "offset": [1775, 1788]}, {"key": "modifications-to-the", "type": "clause", "offset": [1790, 1810]}, {"key": "payable-to", "type": "definition", "offset": [1824, 1834]}, {"key": "direct-result", "type": "definition", "offset": [1887, 1900]}], "samples": [{"hash": "1Wz5EyOyJIK", "uri": "/contracts/1Wz5EyOyJIK#protocol-modifications", "label": "Clinical Study Agreement", "score": 24.8515464919, "published": true}], "snippet": "In the event future modifications in the Protocol appear desirable, such changes may be made only with the approval of Sponsor, which shall have sole overriding discretion in such matters, and the subsequent approval of the Provider\u2019s EC. If such modifications can be expected to affect the cost for the Study, Provider and Principal Investigator will submit a written estimate to Sponsor for approval. Notwithstanding the foregoing, in the course of performing the Study, if deviation from the Protocol is necessary based on generally accepted standards of clinical research and medical practice relating to the benefit, well-being and 5. Zm\u011bny protokolu. V p\u0159\u00edpad\u011b, \u017ee bude v budoucnu pot\u0159ebn\u00e9 prov\u00e9st zm\u011bny v protokolu, je mo\u017en\u00e9 takov\u00e9 zm\u011bny prov\u00e9st pouze se souhlasem zadavatele, kter\u00fd bude m\u00edt v t\u011bchto z\u00e1le\u017eitostech pr\u00e1vo hlavn\u00edho rozhodnut\u00ed s n\u00e1sledn\u00fdm schv\u00e1len\u00edm EK poskytovatele. Pokud lze o\u010dek\u00e1vat, \u017ee takov\u00e9 zm\u011bny negativn\u011b ovlivn\u00ed n\u00e1klady t\u00e9to studie, p\u0159edlo\u017e\u00ed poskytovatel a hlavn\u00ed zkou\u0161ej\u00edc\u00ed zadavateli ke schv\u00e1len\u00ed p\u00edsemn\u00fd odhad n\u00e1klad\u016f. Bez ohledu na v\u00fd\u0161e uveden\u00e9, pokud se v pr\u016fb\u011bhu prov\u00e1d\u011bn\u00ed studie uk\u00e1\u017ee, \u017ee je nezbytn\u00e1 odchylka od protokolu na z\u00e1klad\u011b obecn\u011b p\u0159ijat\u00fdch standard\u016f klinick\u00e9ho v\u00fdzkumu a l\u00e9ka\u0159sk\u00e9 praxe t\u00fdkaj\u00edc\u00ed se safety of patients, the Provider shall notify Sponsor and CRO in writing prior to implementing such deviation, or in emergency situations, within twenty-four (24) hours thereafter. Any change of the Provider\u2019s and/or the Principal Investigator\u2019s obligations under this Agreement that arises in particular from amendments and/or modifications made to the Protocol by Sponsor shall require, each time, a written amendment to the Agreement made by the Parties, otherwise being null and void. The Parties shall negotiate and agree, in good faith, modifications to the remuneration payable to the Provider and/or the Principal Investigator as a direct result of amendments and/or modifications to the Protocol. prosp\u011bchu, zdrav\u00ed a bezpe\u010dnosti pacient\u016f, poskytovatel p\u00edsemn\u011b vyrozum\u00ed zadavatele a CRO p\u0159ed zaveden\u00edm takov\u00e9 odchylky nebo v nouzov\u00fdch situac\u00edch do dvaceti \u010dty\u0159 (24) hodin pot\u00e9. Jak\u00e1koliv zm\u011bna povinnost\u00ed poskytovatele a/nebo zkou\u0161ej\u00edc\u00edho dle t\u00e9to smlouvy, kter\u00e1 vznikne zejm\u00e9na z dodatk\u016f a/nebo \u00faprav protokolu zadavatelem bude vy\u017eadovat poka\u017ed\u00e9 p\u00edsemn\u00fd dodatek smlouvy sjednan\u00fd mezi smluvn\u00edmi stranami, jinak je neplatn\u00e1. 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Institution and Principal Investigator will not change the manner in which the Protocol is carried out unless agreed upon in writing in advance by Sponsor and the EC, except in the event and to the extent necessary to eliminate apparent immediate hazards to Research Subjects, and in such event, Institution and Principal Investigator will notify Sponsor immediately, in accordance with the provisions of Section 2.8.1(c) of this Agreement. Sponsor will submit Protocol modifications to the relevant Regulatory Agency to the extent required by Applicable Laws and Guidelines. Each of Institution and Principal Investigator will notify Sponsor immediately upon becoming aware of unanticipated problems involving risks to 2.4 \u00dapravy Protokolu. M\u00e1-li Zadavatel z\u00e1jem upravit Protokol, poskytne Hlavn\u00edmu zkou\u0161ej\u00edc\u00edmu upraven\u00fd Protokol ve zn\u011bn\u00ed schv\u00e1len\u00e9m Etickou komis\u00ed. 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Typically, this clause outlines who has the authority to propose or approve modifications, the required notice period, and any documentation or consent needed for changes to take effect. For example, it may require written agreement from all parties before any protocol adjustments are implemented. Its core function is to ensure that any alterations to agreed procedures are managed transparently and with mutual consent, thereby preventing unilateral changes and maintaining operational consistency."}, "json": true, "cursor": ""}}