Study Procedures Sample Clauses
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:
(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;
(ii) An evaluation of impacts of the proposed interconnection on system voltage, stability and thermal limitations, as prescribed in the Reliability Rules;
(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;
(iv) An evaluation of alternatives that would eliminate adverse reliability impacts, if any, resulting from the proposed interconnection; and
(v) An estimate of the increase or decrease in the Total Transfer Capability across each affected Interface.
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. 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. The following sections describe each assessment. The timing of these assessments is noted in Table 4. All Day 1 procedures, except AE assessments, should be completed prior to administration of first dose of study drug.
Study Procedures. Before performing any study procedures, all potential subjects will sign an ICF as outlined in Section 9.2.
Study Procedures. There will be 5 visits during the course of the study:
1. Visit 1 – Screening/Day 0/Baseline
2. Visit 2 – Day 5
3. Visit 3 – Day 28 (Week 4)
4. Visit 4 – Day 84 (Week 12)
5. Visit 5 – Day 89 Informed consent X Photo consent X Demographics/Med History X Concomitant Meds. X Inclusion and exclusion criteria X UPT X X Randomization X Case report form (CRF) X X X X X 3D clinical photography X X X Punch biopsy X X Treatment product injection X X* Stitch removal X X AE Reporting X X X X X *PLLA group required for a second treatment. CaHA group for an optional touch-up.
Study Procedures. The procedures in this study are designed to follow the standard medical care at each study site for women having IVF treatment (you will sign a separate consent at your clinic for your IVF procedures). Your doctor will explain in detail the procedures you will undergo at your clinic, this form is only meant to explain the details of the research study. This study does include randomization into two different treatment groups, but no sham procedures will be done. A sham procedure is a procedure that has no effect or active treatment.
Study Procedures a. Recruitment, Randomization, treatment allocation, and blinding A standardized, IRB approved email will be sent to department chairs describing the study. A research coordinator will reach out to interested participants via phone with the help of an IRB-approved verbal script to introduce the study, confirm eligibility and provide further instructions on how to access and sign the IRB-approved ICD via REDCap using their own electronic devices. It is important that we obtain the consent via REDCAp to a) avoid direct person-to-person contact and comply with social distancing imposed recommendations, and b) minimize the waste of reconstituted BCG by allowing the research personnel to schedule vaccinations in a controlled fashion. Patient registration into the trial will happen immediately after consent has been provided and will involve entering of baseline information into an electronic data capture system (RedCap). Once the eligibility is confirmed and the ICD signed by the participant and stored in REDCap, the research coordinator will randomize the participant and communicate the treatment assignment to the nurse administering the vaccination. The nurse will subsequently assign an appointment and communicate date and time of vaccination with the participant. All eligible participants will receive intradermal injections of BCG:placebo in a 1:1 ratio. Both, participants and investigators will be blinded to the treatment assignments during the study. However, in case of an emergency where it is important to know the treatment received, the investigator and/or participant can reach out to the unblinded study personnel who will provide the unblinded data. All participants will receive their treatment allocation at the end of the study, after the data analysis is finalized. Unblinded personnel will not be involved in the collection and analysis of study data other than the baseline eligibility criteria. The end of the study is defined as the last patient’s last entry in the electronic data capture system.
Study Procedures. After giving written informed consent, prospective subjects will be screened for eligibility, and twelve 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 at least five times the medication half-life plus one week for stabilization before the first experimental session. Subjects taking psychostimulants for ADHD or gabapentin for pain management may continue to take these medications so long as they discontinue use for five half lives prior to each experimental session and resume use of psychostimulants ten days after an experimental session. During the study, benzodiazepines or zolpidem or other anxiolytic or sedative may be used as rescue medications if needed as approved by the qualified investigator 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.