{"component": "clause", "props": {"groups": [{"size": 2, "samples": [{"hash": "h3koTD4GUrq", "uri": "/contracts/h3koTD4GUrq#safety-monitoring", "label": "Contract", "score": 32.4285087585, "published": true}, {"hash": "doNiLlwhx9e", "uri": "/contracts/doNiLlwhx9e#safety-monitoring", "label": "Contract", "score": 31.4321079254, "published": true}], "snippet": "The WELCOMING COUNSELOR must make a diligent and reasonable effort to ensure regular telephone contact between the parent and a child or youth, unless that contact is deemed to be detrimental to the child or youth. The initial telephone contact must take place as soon as practicable, but no later than five hours after the child arrives at The CENTER.", "snippet_links": [{"key": "reasonable-effort", "type": "clause", "offset": [49, 66]}, {"key": "to-ensure", "type": "clause", "offset": [67, 76]}, {"key": "telephone-contact", "type": "clause", "offset": [85, 102]}, {"key": "the-parent", "type": "definition", "offset": [111, 121]}, {"key": "child-or-youth", "type": "definition", "offset": [128, 142]}, {"key": "the-child", "type": "clause", "offset": [195, 204]}, {"key": "as-soon-as-practicable", "type": "definition", "offset": [261, 283]}, {"key": "the-center", "type": "definition", "offset": [341, 351]}], "hash": "64b04a5f005c59f836a7874ac312c1c2", "id": 7}, {"size": 6, "samples": [{"hash": "3VOahVKPq7A", "uri": "/contracts/3VOahVKPq7A#safety-monitoring", "label": "Consultant Agreement", "score": 31.1840229034, "published": true}, {"hash": "bChkvflvEWV", "uri": "/contracts/bChkvflvEWV#safety-monitoring", "label": "Consultant Agreement Amendment", "score": 29.9364681244, "published": true}, {"hash": "glxpZ01cAdp", "uri": "/contracts/glxpZ01cAdp#safety-monitoring", "label": "Consultant Agreement", "score": 29.0780620575, "published": true}], "snippet": "a. Incident Reporting, as defined in the Project Specifications.", "snippet_links": [{"key": "incident-reporting", "type": "clause", "offset": [3, 21]}, {"key": "project-specifications", "type": "definition", "offset": [41, 63]}], "hash": "d7ca33b4e1b9187ad7c9cf6eba11d1a8", "id": 1}, {"size": 6, "samples": [{"hash": "glxpZ01cAdp", "uri": "/contracts/glxpZ01cAdp#safety-monitoring", "label": "Consultant Agreement", "score": 29.0780620575, "published": true}, {"hash": "b3FpViamJin", "uri": "/contracts/b3FpViamJin#safety-monitoring", "label": "Consultant Agreement", "score": 22.861738205, "published": true}], "snippet": "Consultant shall:\na. Ensure that contractor and Consultant workers receive orientation training;\nb. Report any incidents to CIP Safety Manager;\nc. Coordinate with CIP Safety Manager for input to contractor submitted PSR; and\nd. Review safety as a standing agenda item in construction progress meetings.", "snippet_links": [{"key": "consultant-shall", "type": "clause", "offset": [0, 16]}, {"key": "orientation-training", "type": "clause", "offset": [75, 95]}, {"key": "safety-manager", "type": "definition", "offset": [128, 142]}, {"key": "to-contractor", "type": "definition", "offset": [192, 205]}, {"key": "agenda-item", "type": "definition", "offset": [256, 267]}, {"key": "construction-progress-meetings", "type": "clause", "offset": [271, 301]}], "hash": "18b7a2d795005332c90ac20dcf5dd5b1", "id": 2}, {"size": 3, "samples": [{"hash": "byJG1sfd9vQ", "uri": "/contracts/byJG1sfd9vQ#safety-monitoring", "label": "Licence Agreement Concerning Inclusion of Doctoral Thesis in the Institutional Repository of the University of Leiden", "score": 19.996679306, "published": true}, {"hash": "lbXJWFXKIDY", "uri": "/contracts/lbXJWFXKIDY#safety-monitoring", "label": "License Agreement", "score": 19.9785003662, "published": true}, {"hash": "hUyTAoyYSb5", "uri": "/contracts/hUyTAoyYSb5#safety-monitoring", "label": "License Agreement", "score": 19.0198497772, "published": true}], "snippet": "Vaccine formulations with both adjuvants were generally well tolerated. All animals maintained body weights within reference ranges of normal values for the entire duration of the study. There were also no major changes in behaviour, appetite or stool over the period of observation. Apart from palpable inguinal lymph nodes there were no notable local reactions (oedema, erythema, indurations) in all 18 study animals. Levels of aspartate transaminase in the DiCo/ISA immunisation group as well as alanine transaminase and bilirubin in the AM/ISA group showed slight increases on the days following immunisation but returned to normal levels within a week. There was an increase in creatinine levels a day after immunisation in the DiCo/HT group but these also returned to normal levels within a week. Creatinine levels in the DiCo/ISA group were however above normal values at the start of the study and remained at similar high levels throughout the observation period. Levels of blood iron decreased on the days following immunisation in the DiCo/HT group but also returned to normal levels within a week. All other measured clinical chemistry parameters were within normal reference ranges throughout the 70-day observation period. Of the parameters measured for haematology, increases in neutrophil count (and hence white blood cell count) were observed a day after each immunisation, but these again returned to normal values within a week. All other measured parameters were between normal ranges throughout the study. Generally, local reactions were limited to mild reddening of the injection site area, and these resolved within a few days. One animal in the AM/ISA group however developed stiffness in the upper leg muscle to a degree that limited movement of the left leg. This adverse event was first observed 14 days after the last immunisation (day 70) and had not resolved on day 126. Given this observation, which lasted for more than 56 days, the amount of discomfort to this animal was rated moderate to serious. IgG levels against seven AMA1 alleles and MSP119 at all sampling time points were determined using a harmonized ELISA. The three vaccine formulations induced appreciable levels of antibodies against the tested antigens and titres against all antigens increased in a similar manner and generally peaked on day 70, two weeks after the final vaccine injections were given. IgG titres against the FVO AMA1 allele at all time-points are presented in Figure 1 and day 70 titres against all antigens are presented in Figure 2. Beyond day 70, IgG titres in the two DiCo mix immunisation groups showed a decline that was statistically significantly lower on day 126 compared to day 70 levels (p < 0.05 for all AMA1 antigens, Student t test). Both the anti-AMA1 and anti-MSP119 levels for the AM/ISA group were however not significantly different on days 70 and 126 (p > 0.05, Student t test). Vaccine-induced IgG titres against all seven AMA1 capture antigens were generally highest in the DiCo/HT group by day 70. A comparison of the geometric mean titres, either for the same immunisation group against all AMA1 antigens, or for all groups against the same capture antigen, showed that there were no statistically significant differences (P > 0.05, one-way ANOVA). Anti- AMA1 IgG titres varied most amongst animals in the AM group, with four of the six animals having very low IgG titres against all antigens and the other two having exceptionally high titres (Figure 2).", "snippet_links": [{"key": "duration-of-the-study", "type": "clause", "offset": [164, 185]}, {"key": "changes-in", "type": "definition", "offset": [212, 222]}, {"key": "period-of", "type": "clause", "offset": [261, 270]}, {"key": "a-week", "type": "definition", "offset": [650, 656]}, {"key": "a-day", "type": "definition", "offset": [701, 706]}, {"key": "observation-period", "type": "clause", "offset": [953, 971]}, {"key": "site-area", "type": "definition", "offset": [1602, 1611]}, {"key": "adverse-event", "type": "definition", "offset": [1790, 1803]}, {"key": "days-after", "type": "definition", "offset": [1826, 1836]}, {"key": "day-70", "type": "definition", "offset": [1860, 1866]}, {"key": "two-weeks", "type": "clause", "offset": [2345, 2354]}, {"key": "the-final", "type": "clause", "offset": [2361, 2370]}, {"key": "figure-1", "type": "definition", "offset": [2477, 2485]}, {"key": "figure-2", "type": "clause", "offset": [2542, 2550]}, {"key": "group-by", "type": "clause", "offset": [3021, 3029]}, {"key": "geometric-mean", "type": "definition", "offset": [3058, 3072]}, {"key": "statistically-significant-differences", "type": "clause", "offset": [3225, 3262]}, {"key": "very-low", "type": "clause", "offset": [3393, 3401]}], "hash": "555d30ed9e5d0d503fbe02768c3b7a07", "id": 3}, {"size": 3, "samples": [{"hash": "gYieRH5IjVP", "uri": "/contracts/gYieRH5IjVP#safety-monitoring", "label": "Clinical Trial Agreement (Amplitude Healthcare Acquisition Corp)", "score": 32.603012085, "published": true}, {"hash": "bQb0mgazHwt", "uri": "/contracts/bQb0mgazHwt#safety-monitoring", "label": "Clinical Trial Agreement", "score": 24.1307315826, "published": true}], "snippet": "In accordance with NIH guidelines the Company and the NIAID agree that the following type(s) of safety monitoring is (are) necessary and appropriate for this Clinical Trial:", "snippet_links": [{"key": "in-accordance-with", "type": "definition", "offset": [0, 18]}, {"key": "the-company-and-the", "type": "clause", "offset": [34, 53]}, {"key": "necessary-and-appropriate", "type": "clause", "offset": [123, 148]}, {"key": "clinical-trial", "type": "definition", "offset": [158, 172]}], "hash": "f24a8429d38e4c06468a494176f2ece9", "id": 4}, {"size": 2, "samples": [{"hash": "1jHXJWoOVi", "uri": "/contracts/1jHXJWoOVi#safety-monitoring", "label": "Clinical Trial Agreement (Mesoblast LTD)", "score": 26.8343601227, "published": true}, {"hash": "7HPwDxTYln8", "uri": "/contracts/7HPwDxTYln8#safety-monitoring", "label": "Clinical Trial Agreement (Mesoblast LTD)", "score": 25.9390830994, "published": true}], "snippet": "In accordance with NIH guidelines, the Company and the NHLBI agree that the following type(s) of safety monitoring is (are) necessary and appropriate for this Clinical Trial: DSMB. If a DSMB is constituted or is in place for the Clinical Trial, the NHLBI or CTSN DCC will notify the Company in advance of any DSMB review. The Company may participate in and will receive the open session reports of the DSMB. The recommendations derived from the closed sessions, redacted to maintain blinding of the Company to control data, will also be communicated to the Company.", "snippet_links": [{"key": "in-accordance-with", "type": "definition", "offset": [0, 18]}, {"key": "the-company-and-the", "type": "clause", "offset": [35, 54]}, {"key": "necessary-and-appropriate", "type": "clause", "offset": [124, 149]}, {"key": "clinical-trial", "type": "definition", "offset": [159, 173]}, {"key": "in-place", "type": "clause", "offset": [212, 220]}, {"key": "notify-the", "type": "clause", "offset": [272, 282]}, {"key": "in-advance", "type": "clause", "offset": [291, 301]}, {"key": "participate-in", "type": "definition", "offset": [338, 352]}, {"key": "open-session", "type": "definition", "offset": [374, 386]}, {"key": "reports-of", "type": "clause", "offset": [387, 397]}, {"key": "closed-sessions", "type": "clause", "offset": [445, 460]}, {"key": "to-maintain", "type": "clause", "offset": [471, 482]}, {"key": "of-the-company", "type": "clause", "offset": [492, 506]}, {"key": "control-data", "type": "clause", "offset": [510, 522]}, {"key": "to-the-company", "type": "definition", "offset": [550, 564]}], "hash": "08dfcb6eef5170143127577a4b8b6c71", "id": 5}, {"size": 2, "samples": [{"hash": "67KVLz1sOlJ", "uri": "/contracts/67KVLz1sOlJ#safety-monitoring", "label": "License and Collaboration Agreement (Zymeworks Inc.)", "score": 34.1772766113, "published": true}, {"hash": "bMHayD2qCbX", "uri": "/contracts/bMHayD2qCbX#safety-monitoring", "label": "License and Collaboration Agreement (Jazz Pharmaceuticals PLC)", "score": 33.9253921509, "published": true}], "snippet": "Zymeworks shall conduct all post-marketing safety surveillance required by a Regulatory Authority in the Territory for Licensed Products in connection with the Zymeworks Ongoing Studies, at Jazz\u2019s cost and expense in accordance with a budget mutually agreed to by the Parties. Zymeworks shall provide the results of any such post-marketing safety surveillance to Jazz for Jazz\u2019s submission of such results to the applicable Regulatory Authority. Otherwise, Jazz shall be responsible for all post-marketing safety surveillance and reporting required in the Territory for Licensed Products, and such responsibility shall be included in the SDEA Agreement.", "snippet_links": [{"key": "required-by", "type": "definition", "offset": [63, 74]}, {"key": "in-the-territory", "type": "clause", "offset": [98, 114]}, {"key": "licensed-products", "type": "clause", "offset": [119, 136]}, {"key": "in-connection-with", "type": "clause", "offset": [137, 155]}, {"key": "ongoing-studies", "type": "definition", "offset": [170, 185]}, {"key": "cost-and-expense", "type": "clause", "offset": [197, 213]}, {"key": "in-accordance-with", "type": "definition", "offset": [214, 232]}, {"key": "by-the-parties", "type": "clause", "offset": [261, 275]}, {"key": "provide-the", "type": "clause", "offset": [293, 304]}, {"key": "submission-of", "type": "clause", "offset": [379, 392]}, {"key": "applicable-regulatory-authority", "type": "definition", "offset": [413, 444]}, {"key": "responsible-for", "type": "clause", "offset": [471, 486]}, {"key": "reporting-required", "type": "clause", "offset": [530, 548]}], "hash": "ac417221b3e569f2ddb5a7a91e4eddd1", "id": 6}, {"size": 2, "samples": [{"hash": "dD10JSz0mAA", "uri": "/contracts/dD10JSz0mAA#safety-monitoring", "label": "Collaboration and License Agreement (Regulus Therapeutics Inc.)", "score": 25.1587944031, "published": true}], "snippet": "In an effort to maximize understanding of the safety profile and pharmacokinetics of Regulus compounds, Sanofi will cooperate with Regulus and forward safety information to Regulus designated contact persons. This includes transmission of serious adverse events collected from Sanofi sponsored studies in a timely fashion as agreed in", "snippet_links": [{"key": "the-safety", "type": "clause", "offset": [42, 52]}, {"key": "cooperate-with", "type": "clause", "offset": [116, 130]}, {"key": "safety-information", "type": "clause", "offset": [151, 169]}, {"key": "designated-contact-persons", "type": "clause", "offset": [181, 207]}, {"key": "serious-adverse-events", "type": "clause", "offset": [239, 261]}, {"key": "as-agreed", "type": "clause", "offset": [322, 331]}], "hash": "670ff3f32a1318db7ff2fa2999d3925e", "id": 8}, {"size": 1, "samples": [{"hash": "l2msKYihl8D", "uri": "/contracts/l2msKYihl8D#safety-monitoring", "label": "License and Supply Agreement (Biofrontera AG)", "score": 30.3223819733, "published": true}], "snippet": "The Parties, through the JSC, shall discuss and establish standard operating procedures (SOPs) for exchange of any and all information on serious Adverse Drug Events as defined by any regulatory Governmental Authority (hereinafter referred to as \u201cADE\u201d) and any other ADE in connection with any use of the Compound and/or the Products which the Parties are obligated to report to any regulatory authorities or Governmental Authority in accordance with applicable regulations or requirements. Such procedures shall be established at such time as considered relevant by the Parties, but in any event shall be established so as to enable the Company and F\u2587\u2587\u2587\u2587\u2587 to comply with all regulatory and legal requirements and the terms of any regulatory approval. The Company and F\u2587\u2587\u2587\u2587\u2587 shall promptly exchange any and all data or other information which is either acquired or otherwise becomes known to them regarding ADEs associated with or related to the use of the Compound or the Products.", "snippet_links": [{"key": "standard-operating-procedures", "type": "definition", "offset": [58, 87]}, {"key": "information-on", "type": "clause", "offset": [123, 137]}, {"key": "adverse-drug-events", "type": "clause", "offset": [146, 165]}, {"key": "governmental-authority", "type": "definition", "offset": [195, 217]}, {"key": "in-connection-with", "type": "clause", "offset": [271, 289]}, {"key": "the-products", "type": "clause", "offset": [321, 333]}, {"key": "parties-are", "type": "clause", "offset": [344, 355]}, {"key": "report-to", "type": "clause", "offset": [369, 378]}, {"key": "regulatory-authorities", "type": "definition", "offset": [383, 405]}, {"key": "in-accordance-with", "type": "definition", "offset": [432, 450]}, {"key": "applicable-regulations", "type": "definition", "offset": [451, 473]}, {"key": "by-the-parties", "type": "clause", "offset": [564, 578]}, {"key": "the-company", "type": "definition", "offset": [634, 645]}, {"key": "comply-with", "type": "definition", "offset": [660, 671]}, {"key": "regulatory-and-legal-requirements", "type": "clause", "offset": [676, 709]}, {"key": "terms-of", "type": "clause", "offset": [718, 726]}, {"key": "regulatory-approval", "type": "clause", "offset": [731, 750]}, {"key": "information-which", "type": "clause", "offset": [825, 842]}, {"key": "associated-with", "type": "definition", "offset": [912, 927]}, {"key": "related-to", "type": "definition", "offset": [931, 941]}], "hash": "5da4a402b1c6394e85a9d98524a4fc70", "id": 9}, {"size": 1, "samples": [{"hash": "3m4XEd67qx4", "uri": "/contracts/3m4XEd67qx4#safety-monitoring", "label": "Clinical Trial Agreement (Amplitude Healthcare Acquisition Corp)", "score": 32.603012085, "published": true}], "snippet": "In accordance with NIH guidelines Company and NIAID agree that the following type(s) of safety monitoring is (are) necessary and appropriate for this Clinical Trial: Sponsor Medical Monitor (SMM). Sponsor has appointed a physician with relevant expertise, [\u2026***\u2026], whose primary responsibility will be to provide safety monitoring for the Clinical Trial in a timely fashion. [\u2026***\u2026] will review of adverse events, per Protocol specification, and follow-up through resolution. [\u2026***\u2026] will evaluate individual and cumulative participant data when making recommendations regarding the safe continuation of the Clinical Trial.", "snippet_links": [{"key": "in-accordance-with", "type": "definition", "offset": [0, 18]}, {"key": "necessary-and-appropriate", "type": "clause", "offset": [115, 140]}, {"key": "clinical-trial", "type": "definition", "offset": [150, 164]}, {"key": "medical-monitor", "type": "definition", "offset": [174, 189]}, {"key": "primary-responsibility", "type": "definition", "offset": [271, 293]}, {"key": "to-provide", "type": "clause", "offset": [302, 312]}, {"key": "review-of", "type": "clause", "offset": [388, 397]}, {"key": "adverse-events", "type": "definition", "offset": [398, 412]}, {"key": "protocol-specification", "type": "definition", "offset": [418, 440]}, {"key": "participant-data", "type": "clause", "offset": [524, 540]}, {"key": "continuation-of-the", "type": "clause", "offset": [588, 607]}], "hash": "1abf6a4017c7b68748f803c066d72570", "id": 10}], "next_curs": "CloSVGoVc35sYXdpbnNpZGVyY29udHJhY3RzcjYLEhZDbGF1c2VTbmlwcGV0R3JvdXBfdjU2IhpzYWZldHktbW9uaXRvcmluZyMwMDAwMDAwYQyiAQJlbhgAIAA=", "clause": {"size": 31, "parents": [["compensation-table-attachment-c", "Compensation Table \u2013 Attachment C"], ["completion-time", "Completion Time"], ["services", "Services"], ["deliverables", "Deliverables"], ["investigational-new-drug-application-sponsorship", "Investigational New Drug Application Sponsorship"]], "children": [["pregnancy", "Pregnancy"], ["susar-reporting", "SUSAR reporting"], ["description-of-study-parameters", "DESCRIPTION OF STUDY PARAMETERS"], ["managing-abnormal-laboratory-test-values", "Managing Abnormal Laboratory Test Values"], ["serious-adverse-events", "Serious Adverse Events"]], "title": "Safety Monitoring", "id": "safety-monitoring", "related": [["program-monitoring", "Program Monitoring", "Program Monitoring"], ["safety-boots", "Safety Boots", "Safety Boots"], ["contract-monitoring", "Contract Monitoring", "Contract Monitoring"], ["analysis-and-monitoring", "ANALYSIS AND MONITORING", "ANALYSIS AND MONITORING"], ["evaluation-testing-and-monitoring", "Evaluation, Testing, and Monitoring", "Evaluation, Testing, and Monitoring"]], "related_snippets": [], "updated": "2025-07-23T06:00:50+00:00"}, "json": true, "cursor": ""}}