{"component": "clause", "props": {"groups": [{"snippet_links": [{"key": "principal-investigator", "type": "clause", "offset": [0, 22]}, {"key": "by-sponsor", "type": "clause", "offset": [58, 68]}, {"key": "signed-on-behalf-of", "type": "clause", "offset": [87, 106]}, {"key": "trial-subject", "type": "definition", "offset": [112, 125]}, {"key": "related-procedure", "type": "definition", "offset": [149, 166]}, {"key": "the-trial", "type": "clause", "offset": [178, 187]}, {"key": "informovan\u00fd-souhlas", "type": "clause", "offset": [200, 219]}, {"key": "hlavn\u00ed-zkou\u0161ej\u00edc\u00ed", "type": "clause", "offset": [221, 238]}, {"key": "formul\u00e1\u0159-informovan\u00e9ho-souhlasu", "type": "clause", "offset": [406, 437]}], "samples": [{"hash": "FlvDdROdgi", "uri": "/contracts/FlvDdROdgi#informed-consent", "label": "Clinical Trial Agreement", "score": 33.1897354126, "published": true}, {"hash": "cBScesjUIS6", "uri": "/contracts/cBScesjUIS6#informed-consent", "label": "Clinical Trial Agreement", "score": 30.9330463409, "published": true}, {"hash": "3c3BYIhQfa9", "uri": "/contracts/3c3BYIhQfa9#informed-consent", "label": "Clinical Trial Agreement", "score": 28.7010746002, "published": true}], "size": 27, "snippet": "Principal Investigator shall ensure that the ICF approved by Sponsor, IEC and/or RA is signed on behalf of each Trial Subject before the first Trial related procedure starts for the Trial Subject. 8. Informovan\u00fd souhlas. Hlavn\u00ed zkou\u0161ej\u00edc\u00ed je povinen zajistit, \u017ee p\u0159ed zah\u00e1jen\u00edm prvn\u00edch postup\u016f klinick\u00e9ho hodnocen\u00ed u subjektu klinick\u00e9ho hodnocen\u00ed bude jm\u00e9nem ka\u017ed\u00e9ho subjektu klinick\u00e9ho hodnocen\u00ed podeps\u00e1n formul\u00e1\u0159 informovan\u00e9ho souhlasu schv\u00e1len\u00fd zadavatelem, NEK a/nebo R\u00da.", "hash": "9ad792a3a6bccf8132abc01b28475412", "id": 1}, {"snippet_links": [{"key": "independent-legal-counsel", "type": "definition", "offset": [45, 70]}, {"key": "the-content", "type": "clause", "offset": [86, 97]}, {"key": "legal-effect", "type": "definition", "offset": [99, 111]}, {"key": "consequences-of", "type": "definition", "offset": [117, 132]}, {"key": "entering-into-this-agreement", "type": "clause", "offset": [160, 188]}, {"key": "undue-influence", "type": "definition", "offset": [227, 242]}], "samples": [{"hash": "9zAfjhWR15a", "uri": "/contracts/9zAfjhWR15a#informed-consent", "label": "Marital Separation Agreement", "score": 30.3573379517, "published": true}, {"hash": "lQdLBajGPCz", "uri": "/contracts/lQdLBajGPCz#informed-consent", "label": "Marital Separation Agreement", "score": 30.2943782806, "published": true}, {"hash": "jz8VKNtvudX", "uri": "/contracts/jz8VKNtvudX#informed-consent", "label": "Marital Separation Agreement", "score": 30.2943782806, "published": true}], "size": 26, "snippet": "Both of us have reviewed this Agreement with independent legal counsel. We understand the content, legal effect, and consequences of this Agreement, and we are entering into this Agreement voluntarily, free from duress, fraud, undue influence, or coercion of any kind.", "hash": "c5128c75632dedce276dcd14db0bdc7a", "id": 2}, {"snippet_links": [{"key": "to-provide", "type": "clause", "offset": [93, 103]}, {"key": "recipient-to-undertake-the-project", "type": "clause", "offset": [121, 155]}, {"key": "in-the-event-of", "type": "definition", "offset": [173, 188]}, {"key": "use-of-the-materials", "type": "clause", "offset": [199, 219]}, {"key": "secondary-uses", "type": "clause", "offset": [272, 286]}, {"key": "approved-by", "type": "definition", "offset": [297, 308]}, {"key": "where-reasonably", "type": "clause", "offset": [357, 373]}, {"key": "by-the-recipient", "type": "clause", "offset": [447, 463]}, {"key": "on-termination-of-this-agreement", "type": "clause", "offset": [591, 623]}, {"key": "other-arrangements", "type": "clause", "offset": [692, 710]}, {"key": "by-the-provider", "type": "clause", "offset": [731, 746]}, {"key": "clause-8", "type": "clause", "offset": [753, 761]}, {"key": "associated-data", "type": "definition", "offset": [809, 824]}, {"key": "public-domain", "type": "clause", "offset": [935, 948]}, {"key": "the-provider-must", "type": "clause", "offset": [1069, 1086]}, {"key": "in-writing", "type": "definition", "offset": [1099, 1109]}], "samples": [{"hash": "hRuOVMXfjmi", "uri": "/contracts/hRuOVMXfjmi#informed-consent", "label": "Material Transfer Agreement", "score": 32.0315322876, "published": true}, {"hash": "bihpCxpbe9P", "uri": "/contracts/bihpCxpbe9P#informed-consent", "label": "Material Transfer Agreement", "score": 28.4319534302, "published": true}, {"hash": "anmd5gTDWNI", "uri": "/contracts/anmd5gTDWNI#informed-consent", "label": "Material Transfer Agreement", "score": 26.3717308044, "published": true}], "size": 12, "snippet": "Informed Consent requires that: the Provider has obtained informed consent from the Donor(s) to provide Materials to the Recipient to undertake the Project as contemplated. In the event of Secondary Use of the Materials, the Donor(s) have consented thereto insofar as the Secondary Uses have been approved by the HREC. the Donor(s) have been informed that, where reasonably possible, the Provider will inform them of developments or progress made by the Recipient in the Project and which is relevant to the Donor(s)\u2019 Informed Consent. the Donor(s) have been informed and have accepted that on termination of this agreement, the Material will be returned to the Provider or destroyed, or any other arrangements made, as determined by the Provider under clause 8. the Donor(s) are aware that all Materials and associated data are de-identified. Disclosure to Donor(s) has been made in the event that Materials will be released into the public domain. should the Recipient wish to conduct studies or use the Material for any other purpose than that approved by the HREC, the Provider must be notified in writing and HREC approval must first be obtained.", "hash": "e3aee2a723801cf335469486eda0d092", "id": 4}, {"snippet_links": [{"key": "principal-investigator", "type": "clause", "offset": [18, 40]}, {"key": "information-sheet", "type": "clause", "offset": [71, 88]}, {"key": "approved-by", "type": "definition", "offset": [92, 103]}, {"key": "ethics-committee", "type": "definition", "offset": [108, 124]}, {"key": "written-informed-consent", "type": "clause", "offset": [139, 163]}, {"key": "study-subject", "type": "definition", "offset": [174, 187]}, {"key": "prior-to", "type": "definition", "offset": [188, 196]}, {"key": "specific-procedures", "type": "clause", "offset": [234, 253]}, {"key": "according-to", "type": "definition", "offset": [268, 280]}, {"key": "the-protocol", "type": "clause", "offset": [281, 293]}], "samples": [{"hash": "fZ9VzYW10x1", "uri": "/contracts/fZ9VzYW10x1#informed-consent", "label": "Clinical Trial Agreement", "score": 29.5114917755, "published": true}, {"hash": "fsdmlZxZMhA", "uri": "/contracts/fsdmlZxZMhA#informed-consent", "label": "Clinical Trial Agreement", "score": 28.5917358398, "published": true}, {"hash": "fDsmU6LaEP9", "uri": "/contracts/fDsmU6LaEP9#informed-consent", "label": "Clinical Trial Agreement", "score": 28.0990104675, "published": true}], "size": 20, "snippet": "1.6.1 Institution/Principal Investigator undertakes to use the patient information sheet as approved by the Ethics Committee and to obtain written informed consent from each Study subject prior to inclusion or initiation of any Study specific procedures for screening according to the Protocol.", "hash": "6708df872acdf8ea8dd2ffca27ad5504", "id": 3}, {"snippet_links": [{"key": "written-informed-consent", 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"/contracts/cusMZVdeJAf#informed-consent", "label": "Non Patient Specific Order", "score": 25.0041065216, "published": true}, {"hash": "8n88uqBOVS6", "uri": "/contracts/8n88uqBOVS6#informed-consent", "label": "Non Patient Specific Order", "score": 25.0041065216, "published": true}], "size": 9, "snippet": "Pharmacy must obtain written informed consent from each individual (or if the individual is incapable of consenting, the person legally responsible for the individual) prior to administering a vaccine.8 Pharmacy must ensure that each individual is informed of potential side effects and adverse reactions orally and in writing prior to administering a vaccine.9 Each individual must be provided with information on the importance of having a primary care provider, in a form or format developed by the Commissioner of Health.10", "hash": "770e0cdf77c1546ff1e856fe50636896", "id": 7}, {"snippet_links": [{"key": "use-or-disclosure-of-information", "type": "clause", "offset": [92, 124]}, {"key": "the-cms", "type": "clause", "offset": [154, 161]}, {"key": "agreement-between", "type": "clause", "offset": [184, 201]}, {"key": "in-writing", "type": "definition", "offset": [245, 255]}, {"key": "signed-by-the", "type": "clause", "offset": [257, 270]}, {"key": "consenting-party", "type": "definition", "offset": [271, 287]}, {"key": "subject-to", "type": "definition", "offset": [293, 303]}, {"key": "right-of-revocation", "type": "clause", "offset": [306, 325]}, {"key": "assistance-to", "type": "clause", "offset": [386, 399]}, {"key": "to-grant-consent", "type": "clause", "offset": [437, 453]}, {"key": "consumer-information", "type": "definition", "offset": [505, 525]}, {"key": "terms-and", "type": "clause", "offset": [671, 680]}, {"key": "plain-language", "type": "clause", "offset": [684, 698]}, {"key": "the-consumer", "type": "definition", "offset": [738, 750]}, {"key": "terms-of-the", "type": "clause", "offset": [775, 787]}, {"key": "the-purpose", "type": "clause", "offset": 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"published": true}, {"hash": "6o1HxJlZt3d", "uri": "/contracts/6o1HxJlZt3d#informed-consent", "label": "Agreement Between CMS and Certified Application Counselor Designated Organization", "score": 24.9835720062, "published": true}], "size": 9, "snippet": "i. CDO and/or CAC must obtain informed consent from Consumers for any creation, collection, use or disclosure of information that is not authorized under the CMS-CDO Agreement and the agreement between CDO and CAC. Such informed consent must be in writing, signed by the consenting party, and subject to a right of revocation.\nii. CDO and CAC are prohibited from denying information or assistance to persons or entities that do not wish to grant consent for any creation, collection, use or disclosure of Consumer information that is not authorized under the CMS-CDO Agreement and the agreement between CDO and CAC.\niii. Informed consent must:\n1. Be provided in specific terms and in plain language;\n2. Identify who will obtain access to the Consumer\u2019s information under the terms of the informed consent;\n3. Describe the purpose for which the informed consent is being obtained;\n4. Explain what information the CDO and/or CAC will use or disclose to a specific recipient(s);\n5. Provide notice of a Consumer\u2019s ability to revoke the consent at any time; and\n6. Include an expiration date or event, unless effectively revoked in writing by the Consumer before that date or event.\niv. Informed consent documents must be appropriately secured and retained for no less than six (6) years, unless a different and longer retention period has already been provided under other applicable Federal law.", "hash": "c5e701188d26a9e3854c9138f17d3884", "id": 9}, {"snippet_links": [{"key": "consent-form", "type": "clause", "offset": [48, 60]}, {"key": "msd-compound-study", "type": "definition", "offset": [69, 87]}, {"key": "provisions-regarding", "type": "clause", "offset": [109, 129]}, {"key": "data-sharing", "type": "clause", "offset": [151, 163]}, {"key": "use-of-samples", "type": "clause", "offset": [172, 186]}, {"key": "sample-testing", "type": "definition", "offset": [190, 204]}, {"key": "approval-of", "type": "clause", "offset": [231, 242]}, {"key": "understood-and-agreed-that", "type": "clause", "offset": [257, 283]}, {"key": "relating-to", "type": "definition", "offset": [326, 337]}, {"key": "without-modification", "type": "definition", "offset": [407, 427]}], "samples": [{"hash": "kR5CZxxyBFk", "uri": "/contracts/kR5CZxxyBFk#informed-consent", "label": "Clinical Trial Collaboration and Supply Agreement (Eikon Therapeutics, Inc.)", "score": 37.0219039917, "published": true}, {"hash": "hcgmuw6tJZt", "uri": "/contracts/hcgmuw6tJZt#informed-consent", "label": "Clinical Trial Collaboration and Supply Agreement (Eikon Therapeutics, Inc.)", "score": 37.0219039917, "published": true}, {"hash": "4AFrotDm7qm", "uri": "/contracts/4AFrotDm7qm#informed-consent", "label": "Clinical Trial Collaboration and Supply Agreement (Eikon Therapeutics, Inc.)", "score": 37.0219039917, "published": true}], "size": 10, "snippet": "Collaborator shall prepare the patient informed-consent form for the MSD Compound Study (which shall include provisions regarding MSD Compound safety, data sharing and the use of Samples in Sample Testing) in consultation and with approval of MSD (it being understood and agreed that the portions of the informed-consent form relating to the MSD Compound will be provided to Collaborator by MSD and adopted without modification by Collaborator).", "hash": "e92cd938bd1c16bbdbfb9891a677f8cc", "id": 6}, {"snippet_links": [{"key": "informed-consent-form", "type": "clause", "offset": [34, 55]}, {"key": "the-study", "type": "definition", "offset": [60, 69]}, {"key": "provisions-regarding", "type": "clause", "offset": [91, 111]}, {"key": "use-of-samples", "type": "clause", "offset": [116, 130]}, {"key": "sample-testing", "type": "definition", "offset": [134, 148]}, {"key": "in-consultation-with", "type": "definition", "offset": [150, 170]}, {"key": "understood-and-agreed-that", "type": "clause", "offset": [187, 213]}, {"key": "relating-to", "type": "definition", "offset": [255, 266]}, {"key": "merck-compound", "type": "clause", "offset": [293, 307]}, {"key": "to-company", "type": "definition", "offset": [326, 336]}, {"key": "by-merck", "type": "clause", "offset": [337, 345]}, {"key": "changes-to", "type": "clause", "offset": [361, 371]}, {"key": "relate-to", "type": "definition", "offset": [387, 396]}, {"key": "subject-to", "type": "definition", "offset": [474, 484]}, {"key": "prior-written-consent", "type": "clause", "offset": [493, 514]}, {"key": "in-writing", "type": "definition", "offset": [555, 565]}, {"key": "project-manager", "type": "clause", "offset": [577, 592]}, {"key": "alliance-manager", "type": "clause", "offset": [605, 621]}, {"key": "will-provide", "type": "clause", "offset": [629, 641]}, {"key": "written-explanation", "type": "clause", "offset": [661, 680]}, {"key": "days-after", "type": "definition", "offset": [745, 755]}, {"key": "a-copy-of", "type": "clause", "offset": [771, 780]}, {"key": "requested-changes", "type": "definition", "offset": [791, 808]}], "samples": [{"hash": "kYZM8NCVgZQ", "uri": "/contracts/kYZM8NCVgZQ#informed-consent", "label": "Clinical Trial Collaboration and Supply Agreement (ONCOSEC MEDICAL Inc)", "score": 28.9069137573, "published": true}, {"hash": "gahFkgFl7sx", "uri": "/contracts/gahFkgFl7sx#informed-consent", "label": "Clinical Trial Collaboration and Supply Agreement (ONCOSEC MEDICAL Inc)", "score": 28.8138256073, "published": true}], "size": 9, "snippet": "Company shall prepare the patient informed consent form for the Study (which shall include provisions regarding the use of Samples in Sample Testing) in consultation with Merck (it being understood and agreed that the portion of the informed consent form relating to the Sample Testing of the Merck Compound shall be provided to Company by Merck). Any proposed changes to such form that relate to the Merck Compound, including Sample Testing of the Merck Compound, shall be subject to Merck\u2019s prior written consent. Any such proposed changes will be sent in writing to Merck\u2019s Project Manager and Merck\u2019s Alliance Manager. Merck will provide such consent, or a written explanation for why such consent is being withheld, within [*****] Business Days after Merck receives a copy of Company\u2019s requested changes.", "hash": "1c0dabf56e47b58879edc2060d7b276f", "id": 10}, {"snippet_links": [{"key": "written-informed-consent", "type": "clause", "offset": [23, 47]}, {"key": "the-individual", "type": "clause", "offset": [53, 67]}, {"key": "prior-to", "type": "definition", "offset": [68, 76]}, {"key": "consent-to", "type": "definition", "offset": [104, 114]}, {"key": "a-child", "type": "definition", "offset": [135, 142]}, {"key": "in-writing", "type": "definition", "offset": [151, 161]}, {"key": "signed-by", "type": "definition", "offset": [166, 175]}, {"key": "authorized-person", "type": "clause", "offset": [179, 196]}, {"key": "written-consent", "type": "clause", "offset": [202, 217]}, {"key": "the-child", "type": "clause", "offset": [244, 253]}, {"key": "conservator-or-guardian", "type": "definition", "offset": [323, 346]}, {"key": "statement-of", "type": "clause", "offset": [445, 457]}, {"key": "medical-treatment", "type": "definition", "offset": [476, 493]}], "samples": [{"hash": "1fpXMQF1bnJ", "uri": "/contracts/1fpXMQF1bnJ#informed-consent", "label": "Written Protocol for Pharmacist Administered Vaccines", "score": 25.0561256409, "published": true}, {"hash": "hRgBja4ZpnI", "uri": "/contracts/hRgBja4ZpnI#informed-consent", "label": "Written Protocol for Pharmacist Administered Vaccines", "score": 25.0082130432, "published": true}, {"hash": "gzcRNHk9hw4", "uri": "/contracts/gzcRNHk9hw4#informed-consent", "label": "Written Protocol for Pharmacist Administered Vaccines", "score": 25.0082130432, "published": true}], "size": 11, "snippet": "5 Pharmacy must obtain written informed consent from the individual prior to administering the vaccine. Consent to the immunization of a child must be in writing and signed by an authorized person. The written consent must include: the name of the child, the name of one or both parents, if known, the name of any managing conservator or guardian of the child, the name of the person giving consent and the person\u2019s relationship to the child, a statement of the nature of the medical treatment to be given, and the date the treatment is to begin.", "hash": "3bc7c49380ffbc7d7829b3d5fb911f4f", "id": 5}, {"snippet_links": [{"key": "the-principal-investigator", "type": "clause", "offset": [0, 26]}, {"key": "consent-of", "type": "clause", "offset": [61, 71]}, {"key": "prior-to", "type": "definition", "offset": [85, 93]}, {"key": "in-the-study", "type": "clause", "offset": [125, 137]}, {"key": "section-113", "type": "clause", "offset": [190, 202]}, {"key": "with-applicable-laws", "type": "clause", "offset": [222, 242]}, {"key": "institution-shall", "type": "clause", "offset": [244, 261]}, {"key": "subject-to", "type": "definition", "offset": [273, 283]}, {"key": "informed-consent-form", "type": "clause", "offset": [296, 317]}, {"key": "in-advance", "type": "clause", "offset": [354, 364]}, {"key": "by-sponsor", "type": "clause", "offset": [365, 375]}, {"key": "approved-by", "type": "definition", "offset": [413, 424]}, {"key": "the-institution", "type": "clause", "offset": [425, 440]}, {"key": "the-requirements", "type": "clause", "offset": [460, 476]}, {"key": "approval-of", "type": "clause", "offset": [593, 604]}, {"key": "the-sponsor", "type": "clause", "offset": [605, 616]}], "samples": [{"hash": "hKML9Ytfhk4", "uri": "/contracts/hKML9Ytfhk4#informed-consent", "label": "Master Clinical Study Agreement", "score": 28.2276668549, "published": true}, {"hash": "kcu9MtjlsAK", "uri": "/contracts/kcu9MtjlsAK#informed-consent", "label": "Master Clinical Study Agreement", "score": 27.5159511566, "published": true}, {"hash": "hUPYYYEo3Ez", "uri": "/contracts/hUPYYYEo3Ez#informed-consent", "label": "Master Clinical Study Agreement", "score": 27.5159511566, "published": true}], "size": 9, "snippet": "The Principal Investigator shall obtain the written informed consent of each Subject prior to any screening or participation in the Study using the Informed Consent Materials (as defined in Section 11.3) and in accordance with Applicable Laws. Institution shall cause each Subject to complete an informed consent form that has been reviewed and approved in advance by SPONSOR and by an institutional review board approved by the Institution that complies with the requirements of 21 C.F.R. Part 56 (\u201cIRB\u201d). 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