{"component": "clause", "props": {"groups": [{"snippet": "Upon receipt of the interconnection proposal and a written guarantee by the Eligible Customer to pay all costs incurred by the ISO and Transmission Owner(s) conducting the technical studies, the ISO, in cooperation with the Transmission Owner with whose system the Eligible Customer proposes to interconnect, shall perform the technical studies of the proposed interconnection. The ISO shall evaluate each Large Facility using the Interconnection Studies specified in the Large Facility Interconnection Procedures in Attachment X. The technical studies shall address the following:\n(i) An evaluation of the potential significant impacts of the proposed interconnection on NYS Power System reliability, at a level of detail that reflects the magnitude of the impacts and the reasonable likelihood of their occurrence;\n(ii) An evaluation of impacts of the proposed interconnection on system voltage, stability and thermal limitations, as prescribed in the Reliability Rules;\n(iii) An evaluation as to whether modifications to the NYS Power System would be required to maintain Interface transfer capability or comply with the voltage, stability and thermal limitations, as prescribed in the Reliability Rules. The ISO will apply the criteria established by NERC, NPCC and the NYSRC;\n(iv) An evaluation of alternatives that would eliminate adverse reliability impacts, if any, resulting from the proposed interconnection; and\n(v) An estimate of the increase or decrease in the Total Transfer Capability across each affected Interface.", "snippet_links": [{"key": "upon-receipt-of", "type": "definition", "offset": [0, 15]}, {"key": "written-guarantee", "type": "definition", "offset": [51, 68]}, {"key": "eligible-customer", "type": "definition", "offset": [76, 93]}, {"key": "to-pay", "type": "clause", "offset": [94, 100]}, {"key": "costs-incurred", "type": "clause", "offset": [105, 119]}, {"key": "transmission-owner", "type": "clause", "offset": [135, 153]}, {"key": "technical-studies", "type": "clause", "offset": [172, 189]}, {"key": "the-transmission", "type": "clause", "offset": [220, 236]}, {"key": "to-interconnect", "type": "definition", "offset": [292, 307]}, {"key": "the-proposed", "type": "clause", "offset": [348, 360]}, {"key": "the-interconnection-studies", "type": "clause", "offset": [427, 454]}, {"key": "large-facility-interconnection-procedures", "type": "definition", "offset": [472, 513]}, {"key": "system-reliability", "type": "definition", "offset": [682, 700]}, {"key": "level-of-detail", "type": "clause", "offset": [707, 722]}, {"key": "as-prescribed", "type": "definition", "offset": [933, 946]}, {"key": "reliability-rules", "type": "definition", "offset": [954, 971]}, {"key": "modifications-to-the", "type": "clause", "offset": [1007, 1027]}, {"key": "to-maintain", "type": "clause", "offset": [1063, 1074]}, {"key": "comply-with-the", "type": "clause", "offset": [1108, 1123]}, {"key": "the-criteria", "type": "clause", "offset": [1227, 1239]}, {"key": "evaluation-of-alternatives", "type": "clause", "offset": [1289, 1315]}, {"key": "resulting-from-the", "type": "clause", "offset": [1374, 1392]}, {"key": "increase-or-decrease", "type": "clause", "offset": [1446, 1466]}, {"key": "total-transfer-capability", "type": "definition", "offset": [1474, 1499]}], "size": 5, "samples": [{"hash": "120h3wGdQya", "uri": "/contracts/120h3wGdQya#study-procedures", "label": "Tariff Agreement", "score": 28.1634597778, "published": true}, {"hash": "gdwnRLaF3A2", "uri": "/contracts/gdwnRLaF3A2#study-procedures", "label": "Open Access Transmission Tariff (Oatt)", "score": 25.7357978821, "published": true}, {"hash": "bSMJk6x7Ue2", "uri": "/contracts/bSMJk6x7Ue2#study-procedures", "label": "Open Access Transmission Tariff (Oatt)", "score": 23.9452438354, "published": true}], "hash": "6403346b6d34a9e5991c41521cd802ed", "id": 1}, {"snippet": "Upon receipt of the interconnection proposal and a written guarantee by the Eligible Customer to pay all costs incurred by the ISO and Transmission Owner(s) conducting the technical studies, the ISO, in cooperation with the Transmission Owner with whose system the Eligible Customer proposes to interconnect shall perform the technical studies of the proposed interconnection. The ISO shall evaluate each Large Facility using the Interconnection Studies specified in the Large Facility Interconnection Procedures in Attachment X. The technical studies shall address the following:\n3.9.2.1 An evaluation of the potential significant impacts of the proposed interconnection on NYS Power System reliability, at a level of detail that reflects the magnitude\n3.9.2.2 An evaluation of impacts of the proposed interconnection on system voltage, stability and thermal limitations, as prescribed in the Reliability Rules;\n3.9.2.3 An evaluation as to whether modifications to the NYS Power System would be required to maintain Interface transfer capability or comply with the voltage, stability and thermal limitations, as prescribed in the Reliability Rules. The ISO will apply the criteria established by NERC, NPCC and the NYSRC;\n3.9.2.4 An evaluation of alternatives that would eliminate adverse reliability impacts, if any, resulting from the proposed interconnection; and\n3.9.2.5 An estimate of the increase or decrease in the Total Transfer Capability across each affected Interface.", "snippet_links": [{"key": "upon-receipt-of", "type": "definition", "offset": [0, 15]}, {"key": "written-guarantee", "type": "definition", "offset": [51, 68]}, {"key": "eligible-customer", "type": "definition", "offset": [76, 93]}, {"key": "to-pay", "type": "clause", "offset": [94, 100]}, {"key": "costs-incurred", "type": "clause", "offset": [105, 119]}, {"key": "transmission-owner", "type": "clause", "offset": [135, 153]}, {"key": "technical-studies", "type": "clause", "offset": [172, 189]}, {"key": "the-transmission", "type": "clause", "offset": [220, 236]}, {"key": "to-interconnect", "type": "definition", "offset": [292, 307]}, {"key": "the-proposed", "type": "clause", "offset": [347, 359]}, {"key": "the-interconnection-studies", "type": "clause", "offset": [426, 453]}, {"key": "large-facility-interconnection-procedures", "type": "definition", "offset": [471, 512]}, {"key": "system-reliability", "type": "definition", "offset": [685, 703]}, {"key": "level-of-detail", "type": "clause", "offset": [710, 725]}, {"key": "as-prescribed", "type": "definition", "offset": [873, 886]}, {"key": "reliability-rules", "type": "definition", "offset": [894, 911]}, {"key": "modifications-to-the", "type": "clause", "offset": [949, 969]}, {"key": "to-maintain", "type": "clause", "offset": [1005, 1016]}, {"key": "comply-with-the", "type": "clause", "offset": [1050, 1065]}, {"key": "the-criteria", "type": "clause", "offset": [1169, 1181]}, {"key": "evaluation-of-alternatives", "type": "clause", "offset": [1234, 1260]}, {"key": "resulting-from-the", "type": "clause", "offset": [1319, 1337]}, {"key": "increase-or-decrease", "type": "clause", "offset": [1395, 1415]}, {"key": "total-transfer-capability", "type": "definition", "offset": [1423, 1448]}], "size": 2, "samples": [{"hash": "f9rmP57ceNp", "uri": "/contracts/f9rmP57ceNp#study-procedures", "label": "Tariff Agreement", "score": 28.6959114075, "published": true}, {"hash": "1WvOjjvrjHF", "uri": "/contracts/1WvOjjvrjHF#study-procedures", "label": "Service Agreement for Firm Point to Point Transmission Service", "score": 23.1752223969, "published": true}], "hash": "fcf66ec3ca6a1cacb4ac629124203548", "id": 2}, {"snippet": "For New Load or Large Facility Interconnections To The NYS Power System", "snippet_links": [{"key": "new-load", "type": "definition", "offset": [4, 12]}, {"key": "large-facility", "type": "definition", "offset": [16, 30]}, {"key": "nys-power-system", "type": "clause", "offset": [55, 71]}], "size": 2, "samples": [{"hash": "f9rmP57ceNp", "uri": "/contracts/f9rmP57ceNp#study-procedures", "label": "Tariff Agreement", "score": 28.6959114075, "published": true}, {"hash": "fg3aTBIWDBm", "uri": "/contracts/fg3aTBIWDBm#study-procedures", "label": "Tariff Agreement", "score": 24.3470230103, "published": true}], "hash": "eefb0ad83436fcd66c0e5b771d21288d", "id": 3}, {"snippet": "No study procedures are allowed to be conducted until parent\u2019s written informed consent has been obtained (please also refer to chapter 9.\n1). The investigator is responsible for obtaining the parent\u2019s written informed consent after adequate explanation of the aim, study assessments, potential risks and benefits and consequences of the study as well as alternative treatment options.", "snippet_links": [{"key": "written-informed-consent", "type": "clause", "offset": [63, 87]}, {"key": "refer-to", "type": "definition", "offset": [119, 127]}, {"key": "chapter-9", "type": "definition", "offset": [128, 137]}, {"key": "the-investigator", "type": "clause", "offset": [143, 159]}, {"key": "responsible-for", "type": "clause", "offset": [163, 178]}, {"key": "the-parent", "type": "clause", "offset": [189, 199]}, {"key": "study-assessments", "type": "clause", "offset": [266, 283]}, {"key": "risks-and-benefits", "type": "definition", "offset": [295, 313]}, {"key": "consequences-of", "type": "definition", "offset": [318, 333]}, {"key": "the-study", "type": "definition", "offset": [334, 343]}, {"key": "alternative-treatment-options", "type": "definition", "offset": [355, 384]}], "size": 2, "samples": [{"hash": "eiys2wvMbwx", "uri": "/contracts/eiys2wvMbwx#study-procedures", "label": "Study Protocol", "score": 28.687543869, "published": true}], "hash": "17bc203159a26b9aa3aaa2e07a194faa", "id": 4}, {"snippet": "Before performing any study procedures, all potential subjects will sign an ICF as outlined in Section 9.2.", "snippet_links": [{"key": "section-92", "type": "clause", "offset": [95, 106]}], "size": 2, "samples": [{"hash": "8j6ihIdwS37", "uri": "/contracts/8j6ihIdwS37#study-procedures", "label": "Investigator Protocol Agreement", "score": 29.4681777954, "published": true}], "hash": "c4a11afb1eea8cd393c6406e9e6c7d56", "id": 5}, {"snippet": "The following sections describe each assessment. The timing of these assessments is noted in Table 3. All Day 1 procedures, except AE assessments, should be completed prior to administration of first dose of study drug.", "snippet_links": [{"key": "timing-of", "type": "clause", "offset": [53, 62]}, {"key": "table-3", "type": "clause", "offset": [93, 100]}, {"key": "day-1", "type": "definition", "offset": [106, 111]}, {"key": "prior-to", "type": "clause", "offset": [167, 175]}, {"key": "administration-of", "type": "clause", "offset": [176, 193]}, {"key": "first-dose", "type": "definition", "offset": [194, 204]}, {"key": "study-drug", "type": "definition", "offset": [208, 218]}], "size": 2, "samples": [{"hash": "9hXJczMiPK", "uri": "/contracts/9hXJczMiPK#study-procedures", "label": "Investigator's Agreement", "score": 24.3990421295, "published": true}], "hash": "03e46872c96b8470a4afca83f0ddb464", "id": 6}, {"snippet": "Before any Study-specific procedures are performed, the patient and legal guardian (if appropriate) must receive an explanation of all Study procedures and must sign and date an Institutional Review Board (IRB) or Ethics Committee (EC)-approved written informed consent and assent (if applicable) form.", "snippet_links": [{"key": "specific-procedures", "type": "clause", "offset": [17, 36]}, {"key": "legal-guardian", "type": "definition", "offset": [68, 82]}, {"key": "sign-and-date", "type": "clause", "offset": [161, 174]}, {"key": "institutional-review-board", "type": "definition", "offset": [178, 204]}, {"key": "ethics-committee", "type": "definition", "offset": [214, 230]}, {"key": "written-informed-consent", "type": "clause", "offset": [245, 269]}, {"key": "if-applicable", "type": "clause", "offset": [282, 295]}], "size": 1, "samples": [{"hash": "i8u8hg85G30", "uri": "/contracts/i8u8hg85G30#study-procedures", "label": "Investigator Agreement", "score": 27.2736473083, "published": true}], "hash": "acfb62d4f3256513f684b2a4102fcdfa", "id": 7}, {"snippet": "The Informed Consent form must be signed by the patient or his/her legal representative prior to any study-related procedures, with the assent of patients who are legally capable of providing it, at the latest at the Baseline visit. Analyses done on blood samples will favor as much as possible the use of micro-sampling techniques. When limiting blood drawing is needed, laboratory safety parameters (which would have been done as normal disease monitoring) will be prioritized. Please refer to the schedule of assessments in Table 1 and Table 2 for an overview of the procedures to be performed during this long-term follow-up study. If conditioning and/or transplantation have occurred before entry in this follow-up protocol, the corresponding visits will not be performed in the NI-0501-05 protocol. In this case when a patient enters the NI-0501-05 study, he/she will start to be monitored according to the NI-0501-05 remaining visits to be performed in the SOA. During the study, the following time-windows are allowed around visits: - Weekly visits pre-HSCT: \u00b12 days - Pre-conditioning: if this visit is no more than 48 hrs apart from one of the weekly visit pre-HSCT, then these visits may be combined following the most demanding SoA - Wk 1-2-3, D+30 post-HSCT: \u00b12 days - D+60, D+100 post-HSCT: \u00b11 week - 6-mo, 1-yr post-HSCT: \u00b14 weeks If HSCT is not performed, the above described time windows apply to the follow-up visits required to occur after the last NI-0501 infusion. The following assessments will be performed in all patients: at each visit \u25aa \u2587\u2587\u2587\u2587\u2587 \u2587\u2587\u2587\u2587\u2587: body temperature, heart rate, blood pressure and respiratory rate \u25aa Physical examination with particular attention being paid to: - height (at pre-Transplant visit, 100-days, 6- month and 12-month post-Transplant visits), weight - occurrence of skin rashes, jaundice, purpura, bleeding, edema - signs of infections - neurological examination - liver and spleen size (in cm from costal grill) at each visit \u25aa CBC \u25aa Coagulation tests: aPTT, PT, D-dimers and fibrinogen \u25aa Biochemistry: glucose, ferritin, CRP, AST, ALT, \u03b3GT, ALP, LDH, bilirubin, albumin, creatinine, urea, triglycerides \u25aa Urinalysis: glucose, blood, protein, leucocytes, ketones, pH and specific gravity (only at Baseline, D+30, D+60, D+100 visit, 6 months and 1 year/WD visits) Imaging: \u25aa Chest X-ray if clinically indicated every 2 weeks, as long as NI-0501 is detectable in serum at each visit as long as relevant \u25aa Abdominal ultrasound at Baseline, pre-conditioning (as applicable), D+30, D+100 visit and 1 year/WD visits \u25aa Tuberculosis either via polymerase chain reaction [PCR] in any relevant specimen (e.g. blood, urine, broncho- alveolar lavage, gastric aspirate) or by any method agreed to be used in the parent protocol or CU treatment protocol at a given site \u25aa Adenovirus, EBV, CMV by quantitative PCR \u25aa NI-0501 serum concentration if concentration still detectable at previous visit at each visit as long as NI-0501 is detectable At Baseline, Day+100 visit, 1 year/WD visit at each visit Duration of response to treatment: At pre-Conditioning (for patients undergoing HSCT), Day+30, Day+100, 1 year visits \u25aa sCD25, other exploratory markers (e.g. CXCL-9, CXCL-10) \u25aa Total IFN\u03b3 \u25aa Presence of anti-NI-0501 antibodies (ADA) \u25aa Any new AE which has occurred since the last visit should be recorded as well as evolution of ongoing AEs should be checked \u25aa Through assessment of: - HLH disease activity (as defined in the parent protocol in which the patient was originally enrolled) In addition, assessment of survival is to be performed in all patients at each visit. Background disease activity will be assessed in the relevant population (i.e. patients with secondary HLH) at Baseline, Day+30, Day+100, 1 year visits. Post-HSCT outcome measures will be collected in the relevant population at each visit post-HSCT. Unplanned visits may occur should the Investigator need to assess or treat any clinical condition that arises during the study. In the event that, upon the request of the treating physician, NI-0501 treatment needs to be continued beyond Week 8 in patients enrolled in study NI-0501-04, patients will continue receiving NI-0501 in the context of this study at a dose either carried forward from the last administered NI-0501 dose as part of the NI-0501 treatment study the patient was enrolled in, or at an adjusted dose if necessary and depending on NI-0501 PK profile. NI-0501 infusions will be performed at a dose and frequency which will be determined by the Sponsor based on the observed PK profile of the drug and on the patient\u2019s clinical response. The last dose of dexamethasone administered as part of study NI-0501-04 will be carried forward. If tapering is required, it should be performed in accordance to the general corticosteroid tapering rules, and dose modifications will be recorded in the eCRF. The stopping rules described in study protocol NI-0501 the patient was part of (e.g. NI-0501-04-US- P-IND-111015, Section 10) still apply for patients on drug to decide whether the patient should continue to receive NI-0501 infusion. If a patient is not receiving anymore NI-0501 infusions in the context of NI-0501-05 study, he remains in the NI-0501-05 as it is an observational study collecting long term data, unless the patient or his/her legal guardian withdraw their consent. Patients still receiving NI-0501 treatment will be followed-up to monitor safety and efficacy of NI- 0501 treatment until treatment discontinuation and will be followed for 4 weeks as described in the NI-0501 treatment protocol they were part of (e.g. NI-0501-04-US-P-IND-111015) and as detailed in the specific Schedule of Assessment for patients continuing to receive NI-0501 beyond Week 8 (see Appendix A). Upon discontinuation of NI-0501 treatment, assessments described above will be performed as part of the long-term follow-up of these patients.", "snippet_links": [{"key": "informed-consent-form", "type": "definition", "offset": [4, 25]}, {"key": "signed-by-the", "type": "clause", "offset": [34, 47]}, {"key": "legal-representative", "type": "clause", "offset": [67, 87]}, {"key": "prior-to", "type": "clause", "offset": [88, 96]}, {"key": "capable-of", "type": "definition", "offset": [171, 181]}, {"key": "blood-samples", "type": "clause", "offset": [250, 263]}, {"key": "safety-parameters", "type": "clause", "offset": [383, 400]}, {"key": "schedule-of", "type": "definition", "offset": [500, 511]}, {"key": "table-1", "type": "clause", "offset": [527, 534]}, {"key": "table-2", "type": "definition", "offset": [539, 546]}, {"key": "an-overview", "type": "clause", "offset": [551, 562]}, {"key": "procedures-to-be-performed", "type": "clause", "offset": [570, 596]}, {"key": "according-to", "type": "definition", "offset": [896, 908]}, {"key": "during-the-study", "type": "clause", "offset": [969, 985]}, {"key": "following-the", "type": "definition", "offset": [1211, 1224]}, {"key": "all-patients", "type": "definition", "offset": [1533, 1545]}, {"key": "blood-pressure", "type": "definition", "offset": [1606, 1620]}, {"key": "physical-examination", "type": "definition", "offset": [1644, 1664]}, {"key": "specific-gravity", "type": "clause", "offset": [2227, 2243]}, {"key": "agreed-to", "type": "definition", "offset": [2730, 2739]}, {"key": "the-parent", "type": "clause", "offset": [2751, 2761]}, {"key": "treatment-protocol", "type": "clause", "offset": [2777, 2795]}, {"key": "duration-of-response", "type": "definition", "offset": [3042, 3062]}, {"key": "in-addition", "type": "clause", "offset": [3530, 3541]}, {"key": "the-relevant", "type": "clause", "offset": [3664, 3676]}, {"key": "outcome-measures", "type": "clause", "offset": [3778, 3794]}, {"key": "the-investigator", "type": "clause", "offset": [3899, 3915]}, {"key": "in-the-event", "type": "clause", "offset": [3993, 4005]}, {"key": "the-request", "type": "clause", "offset": [4017, 4028]}, {"key": "treating-physician", "type": "definition", "offset": [4036, 4054]}, {"key": "the-context", "type": "clause", "offset": [4196, 4207]}, {"key": "carried-forward", "type": "clause", "offset": [4239, 4254]}, {"key": "the-sponsor", "type": "clause", "offset": [4524, 4535]}, {"key": "based-on", "type": "definition", "offset": [4536, 4544]}, {"key": "in-accordance", "type": "definition", "offset": [4766, 4779]}, {"key": "the-general", "type": "clause", "offset": [4783, 4794]}, {"key": "study-protocol", "type": "definition", "offset": [4911, 4925]}, {"key": "section-10", "type": "clause", "offset": [4993, 5003]}, {"key": "to-receive", "type": "definition", "offset": [5084, 5094]}, {"key": "long-term", "type": "clause", "offset": [5277, 5286]}, {"key": "legal-guardian", "type": "definition", "offset": [5323, 5337]}, {"key": "safety-and-efficacy", "type": "clause", "offset": [5436, 5455]}, {"key": "specific-schedule", "type": "definition", "offset": [5665, 5682]}, {"key": "see-appendix-a", "type": "clause", "offset": [5755, 5769]}], "size": 1, "samples": [{"hash": "bbqn1XtNbt3", "uri": "/contracts/bbqn1XtNbt3#study-procedures", "label": "Investigator Agreement", "score": 29.8682098389, "published": true}], "hash": "9723e48fda5f37bb6df568615cdd5dc6", "id": 8}, {"snippet": "After giving written informed consent, prospective participants will be screened for eligibility, and 12 subjects meeting study criteria will be enrolled. In consultation with their prescribing physician, any individuals taking psychiatric medications will taper off these medications, allowing for a washout period of 5 times the medication half life before the first MDMA administration. During the study, benzodiazepines or zolpidem may be used as rescue medications if needed as approved by the medical doctor responsible for the study. Any subjects who are in psychotherapy with an outside therapist at the time of enrollment may continue that therapy during the study without increasing the number or type of sessions or changing psychotherapists or type of psychotherapy.", "snippet_links": [{"key": "after-giving", "type": "clause", "offset": [0, 12]}, {"key": "written-informed-consent", "type": "clause", "offset": [13, 37]}, {"key": "prospective-participants", "type": "definition", "offset": [39, 63]}, {"key": "in-consultation-with", "type": "definition", "offset": [155, 175]}, {"key": "prescribing-physician", "type": "definition", "offset": [182, 203]}, {"key": "period-of", "type": "clause", "offset": [309, 318]}, {"key": "during-the-study", "type": "clause", "offset": [390, 406]}, {"key": "approved-by", "type": "clause", "offset": [483, 494]}, {"key": "the-medical", "type": "definition", "offset": [495, 506]}, {"key": "responsible-for", "type": "clause", "offset": [514, 529]}, {"key": "at-the-time-of-enrollment", "type": "definition", "offset": [605, 630]}, {"key": "type-of", "type": "definition", "offset": [707, 714]}], "size": 1, "samples": [{"hash": "69sIOj7Ja0Q", "uri": "/contracts/69sIOj7Ja0Q#study-procedures", "label": "Sponsor Agreement", "score": 21.1433582306, "published": true}], "hash": "f9f7e198f414164991ba96a475bb7e52", "id": 9}, {"snippet": "\u200c There will be three (3) visits during the course of the study:\n1. Visit 1 \u2013 Screening/Baseline/Day 0\n2. Visit 2 \u2013 Week 4 (Day 28) 3. Visit 3 \u2013 Week 24 (Day 168) Informed consent X Photo consent X Demographics/Med History X Concomitant Meds. X Inclusion and exclusion criteria X Randomization X Case report form (CRF) X X X Injection per on-label instruction X Touch up (if applicable) X Ultrasound X* X X Standardized photography (2D and 3D) X X X Self-assessment questionnaire X X AE Reporting X X X *Ultrasound at D0 will be performed before injection and immediately post-injection for each product.", "snippet_links": [{"key": "the-study", "type": "definition", "offset": [54, 63]}, {"key": "day-0", "type": "definition", "offset": [97, 102]}, {"key": "week-4", "type": "definition", "offset": [116, 122]}, {"key": "informed-consent", "type": "definition", "offset": [163, 179]}, {"key": "photo-consent", "type": "clause", "offset": [182, 195]}, {"key": "inclusion-and-exclusion-criteria", "type": "clause", "offset": [245, 277]}, {"key": "case-report-form", "type": "definition", "offset": [296, 312]}, {"key": "if-applicable", "type": "clause", "offset": [372, 385]}], "size": 1, "samples": [{"hash": "3BdDvkOo2AI", "uri": "/contracts/3BdDvkOo2AI#study-procedures", "label": "Investigator Agreement", "score": 26.2279262543, "published": true}], "hash": "bfaeeb10d17fc64f0dd2503519bb10f3", "id": 10}], "next_curs": "ClkSU2oVc35sYXdpbnNpZGVyY29udHJhY3RzcjULEhZDbGF1c2VTbmlwcGV0R3JvdXBfdjU2IhlzdHVkeS1wcm9jZWR1cmVzIzAwMDAwMDBhDKIBAmVuGAAgAA==", "clause": {"title": "Study Procedures", "size": 50, "children": [["", ""], ["inclusion-exclusion", "Inclusion/Exclusion"], ["informed-consent", "Informed Consent"], ["medical-history", "Medical History"], ["study-personnel", "Study Personnel"]], "parents": [["incorporation-of-certain-business-practice-standards", "Incorporation of Certain Business Practice Standards"], ["definitions", "Definitions"], ["research-management", "Research Management"], ["counterparts", "Counterparts"], ["procedure-for-third-party-claims", "Procedure for Third Party Claims"]], "id": "study-procedures", "related": [["new-procedures", "New Procedures", "New Procedures"], ["safety-procedures", "Safety Procedures", "Safety Procedures"], ["reply-procedures", "Reply Procedures", "Reply Procedures"], ["hearing-procedures", "Hearing Procedures", "Hearing Procedures"], ["evaluation-procedures", "Evaluation Procedures", "Evaluation Procedures"]], "related_snippets": [], "updated": "2025-07-24T04:27:57+00:00"}, "json": true, "cursor": ""}}