{"component": "clause", "props": {"groups": [{"snippet_links": [{"key": "the-protocol", "type": "clause", "offset": [35, 47]}, {"key": "missed-visits", "type": "clause", "offset": [134, 147]}, {"key": "in-the-event-of-a", "type": "clause", "offset": [175, 192]}, {"key": "major-deviation", "type": "definition", "offset": [193, 208]}, {"key": "study-subject", "type": "clause", "offset": [232, 245]}, {"key": "enrollment-criteria", "type": "clause", "offset": [262, 281]}, {"key": "as-soon-as-possible", "type": "definition", "offset": [342, 361]}, {"key": "in-no-event", "type": "clause", "offset": [367, 378]}, {"key": "days-after", "type": "definition", "offset": [407, 417]}, {"key": "arising-out-of", "type": "definition", "offset": [468, 482]}, {"key": "medical-necessity", "type": "clause", "offset": [483, 500]}, {"key": "subject-safety", "type": "clause", "offset": [511, 525]}, {"key": "failure-to", "type": "clause", "offset": [548, 558]}, {"key": "adhere-to", "type": "clause", "offset": [559, 568]}, {"key": "breach-of-this-agreement", "type": "clause", "offset": [587, 611]}, {"key": "provided-that", "type": "clause", "offset": [612, 625]}, {"key": "the-principal-investigator", "type": "clause", "offset": [626, 652]}, {"key": "the-sponsor", "type": "clause", "offset": [698, 709]}, {"key": "in-writing", "type": "clause", "offset": [745, 755]}, {"key": "reasonable-time", "type": "definition", "offset": [795, 810]}], "size": 8, "samples": [{"hash": "3EWlcSdZXnC", "uri": "/contracts/3EWlcSdZXnC#protocol-deviations", "label": "Clinical Trial Research Agreement", "score": 28.2468276857, "published": true}, {"hash": "gnkhJfzT9Yg", "uri": "/contracts/gnkhJfzT9Yg#protocol-deviations", "label": "Clinical Trial Research Agreement", "score": 22.5092402464, "published": true}, {"hash": "7ptbsGXRd1e", "uri": "/contracts/7ptbsGXRd1e#protocol-deviations", "label": "Clinical Trial Research Agreement", "score": 21.6173853525, "published": true}], "snippet": "In the event of any deviation from the Protocol, Investigators shall record such deviation on a protocol deviation log (e.g., late or missed visits, tests not performed) and, in the event of a major deviation (e.g., enrollment of a Study subject not meeting all enrollment criteria), Institution and Investigators shall notify Sponsor and EC as soon as possible, but in no event later than five (5) working days after the deviation occurs. Deviation from the Protocol arising out of medical necessity for Study subject safety shall not be deemed a failure to adhere to the Protocol or a breach of this Agreement provided that the Principal Investigator shall, within twenty-four (24) hours, notify the Sponsor of any such deviations and confirm in writing the reason for such deviation within a reasonable time thereafter.", "hash": "38ebb5925d1107aab40021409ef2b6d1", "id": 1}, {"snippet_links": [{"key": "based-on", "type": "clause", "offset": [82, 90]}, {"key": "review-of", "type": "clause", "offset": [95, 104]}, {"key": "study-data", "type": "clause", "offset": [105, 115]}, {"key": "prior-to", "type": "definition", "offset": [116, 124]}, {"key": "the-database", "type": "definition", "offset": [133, 145]}, {"key": "nature-of-the", "type": "clause", "offset": [167, 180]}], "size": 1, "samples": [{"hash": "lwda8urR0lR", "uri": "/contracts/lwda8urR0lR#protocol-deviations", "label": "Clinical Study Protocol", "score": 28.0771108958, "published": true}], "snippet": "A listing of protocol deviations will be provided. This deviation listing will be based on the review of study data prior to locking the database and will include the nature of the deviation (e.g., inclusion/exclusion, prohibited therapies).", "hash": "41419d3431c5cc7f23feb437e09b67e6", "id": 4}, {"snippet_links": [{"key": "guidelines-for", "type": "clause", "offset": [56, 70]}, {"key": "good-clinical-practice", "type": "definition", "offset": [71, 93]}, {"key": "ich-gcp", "type": "definition", "offset": [96, 103]}, {"key": "relating-to", "type": "definition", "offset": [106, 117]}, {"key": "the-safety", "type": "clause", "offset": [118, 128]}, {"key": "the-protocol", "type": "clause", "offset": [166, 178]}, {"key": "in-writing", "type": "clause", "offset": [274, 284]}, {"key": "breach-of", "type": "definition", "offset": [380, 389]}, {"key": "for-the-purposes-of", "type": "clause", "offset": [414, 433]}, {"key": "study-protocol", "type": "definition", "offset": [503, 517]}, {"key": "is-likely", "type": "definition", "offset": [525, 534]}, {"key": "integrity-of", "type": "clause", "offset": [582, 594]}, {"key": "the-study", "type": "definition", "offset": [611, 620]}, {"key": "in-addition", "type": "clause", "offset": [665, 676]}, {"key": "governmental-authority", "type": "definition", "offset": [735, 757]}, {"key": "required-by", "type": "definition", "offset": [768, 779]}, {"key": "applicable-law", "type": "clause", "offset": [780, 794]}], "size": 2, "samples": [{"hash": "1gLFmoQkq4z", "uri": "/contracts/1gLFmoQkq4z#protocol-deviations", "label": "Clinical Trial Agreement", "score": 29.7469051197, "published": true}], "snippet": "If principles outlined in the ICH Harmonized Tripartite Guidelines for Good Clinical Practice (\"ICH GCP\") relating to the safety of Subjects require a deviation from the Protocol, ICH GCP should be followed, and the deviation shall immediately be reported to SPONSOR or CRO in writing. Investigator shall also, within twenty-four (24) hours, notify CRO and SPONSOR of any Serious Breach of which he becomes aware. For the purposes of this provision, a \"Serious Breach\" shall mean a breach of ICH GCP or Study Protocol, which is likely to affect (i) the safety of physical or mental integrity of the Subjects of the Study; or (ii) the scientific value of the Study. In addition, Investigator shall promptly inform the IRB or EC and any governmental authority as may be required by Applicable Law of such deviation or breach.", "hash": "18b6f09016bfe6d2a261d9ccce918f8f", "id": 2}, {"snippet_links": [{"key": "requests-for", "type": "clause", "offset": [4, 16]}, {"key": "the-investigator", "type": "clause", "offset": [40, 56]}, {"key": "the-sponsor", "type": "clause", "offset": [84, 95]}, {"key": "in-writing", "type": "clause", "offset": [96, 106]}, {"key": "accepted-by", "type": "definition", "offset": [114, 125]}, {"key": "approved-by", "type": "definition", "offset": [146, 157]}], "size": 1, "samples": [{"hash": "jVl3FzXVu39", "uri": "/contracts/jVl3FzXVu39#protocol-deviations", "label": "Investigator Agreement", "score": 27.835688605, "published": true}], "snippet": "All requests for protocol deviations by the Investigator have to be communicated to the sponsor in writing and if accepted by the Sponsor must be approved by the IRB. If a deviation occurs, the Investigator must inform the Sponsor and IRB in writing within 10 days.", "hash": "d043146f2956b88b470f86d379d8bb0c", "id": 3}, {"snippet_links": [{"key": "in-the-event-of", "type": "definition", "offset": [0, 15]}, {"key": "the-protocol", "type": "clause", "offset": [35, 47]}, {"key": "odchylky-od-protokolu", "type": "clause", "offset": [53, 74]}], "size": 1, "samples": [{"hash": "diTftKQr26K", "uri": "/contracts/diTftKQr26K#protocol-deviations", "label": "Clinical Trial Research Agreement", "score": 27.1126966743, "published": true}], "snippet": "In the event of any deviation from the Protocol, 6.3 Odchylky od protokolu. V p\u0159\u00edpad\u011b jak\u00fdchkoliv odchylek od protokolu", "hash": "df924d7d13a69e5db3c95dbe68df194c", "id": 5}, {"snippet_links": [{"key": "the-principal-investigator", "type": "clause", "offset": [2, 28]}, {"key": "in-a-timely-manner", "type": "definition", "offset": [134, 152]}, {"key": "by-the-principal", "type": "clause", "offset": [153, 169]}, {"key": "the-responsible", "type": "clause", "offset": [253, 268]}, {"key": "monitoring-visits", "type": "clause", "offset": [284, 301]}, {"key": "the-investigator", "type": "clause", "offset": [350, 366]}, {"key": "immediate-hazard", "type": "definition", "offset": [383, 399]}, {"key": "the-protocol", "type": "clause", "offset": [457, 469]}, {"key": "ec-approval", "type": "definition", "offset": [500, 511]}, {"key": "the-sponsor", "type": "clause", "offset": [513, 524]}], "size": 1, "samples": [{"hash": "9hXJczMiPK", "uri": "/contracts/9hXJczMiPK#protocol-deviations", "label": "Investigator's Agreement", "score": 24.3990417522, "published": true}], "snippet": "\u200c The principal investigator or designee must document any protocol deviation. The IRB/EC must be notified of all protocol deviations in a timely manner by the principal investigator or designee as appropriate. Protocol deviations will be documented by the responsible monitor during monitoring visits, and those observations will be communicated to the investigator. If there is an immediate hazard to a patient the principal investigator may deviate from the protocol without prior Sponsor and IRB/EC approval. The Sponsor and IRB/EC must be notified of the deviation.", "hash": "e384f7ed84f0b118b18592d7356a8c72", "id": 6}, {"snippet_links": [{"key": "institution-shall", "type": "clause", "offset": [4, 21]}, {"key": "the-principal-investigator", "type": "clause", "offset": [61, 87]}, {"key": "member-of-the", "type": "clause", "offset": [95, 108]}, {"key": "the-protocol", "type": "clause", "offset": [132, 144]}, {"key": "consent-of", "type": "clause", "offset": [182, 192]}, {"key": "the-safety", "type": "clause", "offset": [224, 234]}, {"key": "rights-of", "type": "definition", "offset": [246, 255]}, {"key": "trial-subject", "type": "definition", "offset": [258, 271]}], "size": 1, "samples": [{"hash": "fQMsiosfaX7", "uri": "/contracts/fQMsiosfaX7#protocol-deviations", "label": "Clinical Trial Agreement", "score": 35.8819167758, "published": true}], "snippet": "The Institution shall not deviate from, and shall not permit the Principal Investigator or any member of the Staff to deviate from, the Protocol in any way without the prior written consent of X4, unless required to protect the safety, health or rights of a Trial subject.", "hash": "0dc0a0b52e6b1c81188a64ad3e1a1dca", "id": 7}, {"snippet_links": [{"key": "the-investigator", "type": "clause", "offset": [0, 16]}, {"key": "the-subject", "type": "clause", "offset": [58, 69]}, {"key": "source-documentation", "type": "definition", "offset": [72, 92]}, {"key": "change-to", "type": "definition", "offset": [189, 198]}, {"key": "the-protocol", "type": "clause", "offset": [200, 212]}, {"key": "immediate-hazard", "type": "definition", "offset": [229, 245]}, {"key": "study-subjects", "type": "definition", "offset": [249, 263]}, {"key": "irb-approval", "type": "clause", "offset": [278, 290]}, {"key": "as-soon-as-possible", "type": "definition", "offset": [292, 311]}, {"key": "protocol-amendments", "type": "clause", "offset": [412, 431]}, {"key": "review-and-approval", "type": "clause", "offset": [467, 486]}, {"key": "regulatory-authorities", "type": "definition", "offset": [522, 544]}, {"key": "if-required", "type": "definition", "offset": [546, 557]}, {"key": "any-change", "type": "definition", "offset": [583, 593]}, {"key": "study-design", "type": "definition", "offset": [629, 641]}, {"key": "study-data", "type": "clause", "offset": [881, 891]}, {"key": "exclusion-criteria", "type": "clause", "offset": [1011, 1029]}, {"key": "fda-regulations", "type": "definition", "offset": [1049, 1064]}, {"key": "monitoring-visits", "type": "clause", "offset": [1179, 1196]}, {"key": "in-writing", "type": "clause", "offset": [1232, 1242]}, {"key": "the-monitor", "type": "clause", "offset": [1246, 1257]}, {"key": "in-a-timely-manner", "type": "definition", "offset": [1344, 1362]}], "size": 1, "samples": [{"hash": "3iSuio8cFQy", "uri": "/contracts/3iSuio8cFQy#protocol-deviations", "label": "Investigator Protocol Agreement", "score": 28.5708527613, "published": true}], "snippet": "The investigator or designee must document and explain in the subject\u2019s source documentation any deviation from the approved protocol. The investigator may implement a deviation from, or a change to, the protocol to eliminate an immediate hazard to study subjects without prior IRB approval. As soon as possible after such an occurrence, the implemented deviation or change, the reasons for it, and any proposed protocol amendments should be submitted to the IRB for review and approval, to SIGA for agreement, and to the regulatory authorities, if required. A protocol deviation is any change, divergence, or departure from the study design or procedures defined in the protocol. An important protocol deviation (sometimes referred to as a protocol violation or a major protocol deviation) is a subset of protocol deviations that might significantly affect the reliability of the study data or that might significantly affect a subject's safety. An important deviation can include nonadherence to inclusion or exclusion criteria or nonadherence to FDA regulations or ICH E6(R2) guidelines. Protocol deviations will be documented by the clinical monitor throughout the course of monitoring visits. The investigator will be notified in writing by the monitor of deviations. The IRB should be notified of all protocol deviations, if appropriate, in a timely manner.", "hash": "504bcde49926b58316cb2a5a78123999", "id": 8}, {"snippet_links": [{"key": "the-investigator", "type": "clause", "offset": [0, 16]}, {"key": "the-protocol", "type": "clause", "offset": [39, 51]}, {"key": "medical-emergencies", "type": "clause", "offset": [62, 81]}, {"key": "minor-changes", "type": "definition", "offset": [125, 138]}, {"key": "validity-of-the", "type": "clause", "offset": [204, 219]}, {"key": "related-to", "type": "clause", "offset": [242, 252]}, {"key": "exclusion-criteria", "type": "clause", "offset": [272, 290]}, {"key": "conduct-of-the-trial", "type": "clause", "offset": [292, 312]}, {"key": "patient-management", "type": "definition", "offset": [314, 332]}, {"key": "patient-assessment", "type": "definition", "offset": [336, 354]}, {"key": "to-be-considered", "type": "clause", "offset": [428, 444]}, {"key": "fda-regulations", "type": "definition", "offset": [565, 580]}, {"key": "iso-14155", "type": "definition", "offset": [588, 597]}, {"key": "in-a-timely-manner", "type": "definition", "offset": [720, 738]}, {"key": "according-to", "type": "definition", "offset": [804, 816]}], "size": 1, "samples": [{"hash": "cSoZPSYFQIP", "uri": "/contracts/cSoZPSYFQIP#protocol-deviations", "label": "Investigator Agreement", "score": 26.2813977632, "published": true}], "snippet": "The investigator will not deviate from the protocol except in medical emergencies or in unforeseen, isolated instances where minor changes are made that will not increase the patient\u2019s risk or affect the validity of the trial. All deviations related to study inclusion or exclusion criteria, conduct of the trial, patient management or patient assessment must be appropriately documented and reported. Other protocol deviations to be considered include non-adherence to the protocol that results in a significant additional risk to the patient, or non-adherence to FDA regulations and/or ISO 14155. The investigator must document and explain any protocol deviation. The IRB should be notified of all protocol deviations in a timely manner. Protocol deviations should be reported to the IRB periodically, according to their requirements.", "hash": "57314857115fec458fca9788ad02abf8", "id": 9}, {"snippet_links": [{"key": "study-conduct", "type": "clause", "offset": [33, 46]}, {"key": "the-protocol", "type": "clause", "offset": [98, 110]}, {"key": "comply-with", "type": "clause", "offset": [141, 152]}, {"key": "the-terms", "type": "definition", "offset": [160, 169]}, {"key": "in-the-course-of", "type": "definition", "offset": [192, 208]}, {"key": "accepted-standards", "type": "definition", "offset": [241, 259]}, {"key": "clinical-research", "type": "clause", "offset": [263, 280]}, {"key": "medical-practice", "type": "definition", "offset": [285, 301]}, {"key": "relating-to", "type": "definition", "offset": [302, 313]}, {"key": "the-benefit", "type": "definition", "offset": [314, 325]}, {"key": "and-safety", "type": "clause", "offset": [338, 348]}, {"key": "study-subjects", "type": "definition", "offset": [356, 370]}, {"key": "institution-and-investigator", "type": "clause", "offset": [446, 474]}, {"key": "the-party", "type": "clause", "offset": [490, 499]}, {"key": "promptly-notify", "type": "clause", "offset": [540, 555]}, {"key": "the-facts", "type": "clause", "offset": [577, 586]}, {"key": "ozn\u00e1men\u00ed-o-poru\u0161en\u00ed", "type": "clause", "offset": [679, 698]}, {"key": "zdravotnick\u00e9-za\u0159\u00edzen\u00ed", "type": "clause", "offset": [861, 882]}], "size": 1, "samples": [{"hash": "iLWBoJQ87xw", "uri": "/contracts/iLWBoJQ87xw#protocol-deviations", "label": "Clinical Trial Agreement", "score": 26.7419575633, "published": true}], "snippet": "Prior to the commencement of the Study conduct, Institution, including Investigator, shall review the Protocol and notify IQVIA if it cannot comply with any of the terms contained therein. If in the course of performing the Study, generally accepted standards of clinical research and medical practice relating to the benefit, well-being and safety of the Study Subjects require a deviation from the Protocol, such standards shall be followed by Institution and Investigator. In such case, the party aware of the need for a deviation shall promptly notify IQVIA and Sponsor of the facts b\u011bhem takov\u00fdch kontrol. Pokud st\u00e1tn\u00ed/spr\u00e1vn\u00ed nebo kontroln\u00ed \u00fa\u0159ad vyd\u00e1 zpr\u00e1vu se zji\u0161t\u011bn\u00edmi, ozn\u00e1men\u00ed o poru\u0161en\u00ed p\u0159edpis\u016f, upozorn\u011bn\u00ed nebo jin\u00e9 sd\u011blen\u00ed t\u00fdkaj\u00edc\u00ed se Studie, Zkou\u0161ej\u00edc\u00edho nebo Institucion\u00e1ln\u00ed hodnot\u00edc\u00ed (nebo pokud n\u011bjak\u00fd jin\u00fd \u00fa\u0159ad vyd\u00e1 podobn\u00fd dokument), za\u0161le Zdravotnick\u00e9 za\u0159\u00edzen\u00ed nebo p\u0159\u00edpadn\u011b Zkou\u0161ej\u00edc\u00ed kopii takov\u00e9ho dokumentu spole\u010dnosti IQVIA neprodlen\u011b, nejpozd\u011bji v\u0161ak do dvaceti \u010dty\u0159 (24) hodin po takov\u00e9 ud\u00e1losti, a po\u017e\u00e1d\u00e1 Zadavatele nebo p\u0159\u00edpadn\u011b spole\u010dnost IQVIA o p\u00edsemn\u00fd souhlas s n\u00e1vrhem odpov\u011bdi na takov\u00fd dokument, ne\u017e ji ode\u0161le p\u0159\u00edslu\u0161n\u00e9mu \u00fa\u0159adu, a to v\u0161e v rozsahu povolen\u00e9m p\u0159\u00edslu\u0161n\u00fdmi pr\u00e1vn\u00edmi p\u0159edpisy.", "hash": "96b708f76bfe3e2472c260998b18a55b", "id": 10}], "next_curs": "ClwSVmoVc35sYXdpbnNpZGVyY29udHJhY3RzcjgLEhZDbGF1c2VTbmlwcGV0R3JvdXBfdjU2Ihxwcm90b2NvbC1kZXZpYXRpb25zIzAwMDAwMDBhDKIBAmVuGAAgAA==", "clause": {"parents": [["correspondence-with-ec", "Correspondence with EC"], ["privacy-notice", "Privacy Notice"], ["sponsor-equipment", "Sponsor Equipment"], ["vybaven\u00ed-zadavatele", "Vybaven\u00ed zadavatele"], ["reporting-serious-adverse-events", "Reporting Serious Adverse Events"]], "children": [["retention-of-records", "Retention of Records"], ["case-report-forms", "Case Report Forms"], ["telephone", "Telephone"]], "title": "Protocol Deviations", "size": 32, "id": "protocol-deviations", "related": [["protocols", "Protocols", "Protocols"], ["deviations", "Deviations", "Deviations"], ["protocol", "Protocol", "Protocol"], ["specifications", "Specifications", "Specifications"], ["technical-specifications", "Technical Specifications", "Technical Specifications"]], "related_snippets": [], "updated": "2025-07-07T12:37:55+00:00", "also_ask": ["What safeguards should be included to address intentional versus unintentional protocol deviations?", "How can the clause allocate responsibility and remedies for protocol deviations between parties?", "What are the most common negotiation points regarding protocol deviation reporting and cure periods?", "How do courts typically interpret and enforce protocol deviation clauses in similar agreements?", "What industry standards or regulatory requirements should inform the drafting of this clause?"], "drafting_tip": "Specify what constitutes a protocol deviation to prevent misinterpretation; outline reporting procedures to ensure timely resolution; assign responsibilities to clarify accountability.", "explanation": "The Protocol Deviations clause defines how departures from the agreed-upon procedures or protocols in a project or clinical study are identified, managed, and reported. It typically outlines the process for documenting any deviations, who must be notified, and the steps required to address or rectify the issue, such as corrective actions or additional oversight. This clause ensures that all parties are aware of and accountable for any inconsistencies, thereby maintaining the integrity of the project and ensuring compliance with regulatory or contractual requirements."}, "json": true, "cursor": ""}}