Study Procedures Clause Samples

Study Procedures. 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: 3.9.2.1 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 3.9.2.2 An evaluation of impacts of the proposed interconnection on system voltage, stability and thermal limitations, as prescribed in the Reliability Rules; 3.9.2.3 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; 3.9.2.4 An evaluation of alternatives that would eliminate adverse reliability impacts, if any, resulting from the proposed interconnection; and 3.9.2.5 An estimate of the increase or decrease in the Total Transfer Capability across each affected Interface.

Study Procedures. For New Load or Large Facility Interconnections To The NYS Power System

Study Procedures. No study procedures are allowed to be conducted until parent’s written informed consent has been obtained (please also refer to chapter 9. 1). The investigator is responsible for obtaining the parent’s 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.

Study Procedures. Before performing any study procedures, all potential subjects will sign an ICF as outlined in Section 9.2.

Study Procedures. 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.

Study Procedures. 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.

Study Procedures. 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: ±2 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: ±2 days - D+60, D+100 post-HSCT: ±1 week - 6-mo, 1-yr post-HSCT: ±4 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 ▪ ▇▇▇▇▇ ▇▇▇▇▇: body temperature, heart rate, blood pressure and respiratory rate ▪ 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 ▪ CBC ▪ Coagulation tests: aPTT, PT, D-dimers and fibrinogen ▪ Biochemistry: glucose, ferritin, CRP, AST, ALT, γGT, ALP, LDH, bilirubin, albumin, creatinine, urea, triglycerides ▪ 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: ▪ 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 ▪ Abdominal ultrasound at Baseline, pre-con...

Study Procedures. 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.

Study Procedures. ‌ There will be three (3) visits during the course of the study: 1. Visit 1 – Screening/Baseline/Day 0 2. Visit 2 – Week 4 (Day 28) 3. Visit 3 – 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.