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. Before performing any study procedures, all potential subjects will sign an ICF as outlined in Section 9.3.2.
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. 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. Patients who present to a primary health care clinic with pulmonary symptoms and who are presumed to have TB disease, will be approached to participate in the study by research recruiters or nurses. Sputum results from the National Health Laboratory System may also be accessed to identify patients who were investigated for TB. Participants will be recruited into either the training or the test cohort, with the test cohort recruitment starting after the training cohort has completed the enrolment of 500 participants. Participants will be required to attend the baseline visit, a week 2 visit (to review results and antibiotic response in those not already diagnosed with TB at this point), a week 8 visit (all participants, to assess TB treatment response in TB cases and to assess alternative diagnosis or resolution of symptoms in non-TB cases) and a week 24 visit (TB participants only, to assure TB was treated successfully). Xxxxxxx and eligible patients will be informed about the study by a research nurse, guided by the informed consent document, and asked to sign the document, after being given the opportunity to ask questions. The participant will receive a copy of the informed consent form, while the original consent form will be filed in the regulatory file and another copy will be filed in the participant’s file. Each recruited participant will be assigned a unique study ID number by the recruiting nurse. Personal and demographic information on each participant will be collected by the nurse using an electronic case report form on a tablet computer. Information such as name, address, telephone numbers, other contact person, age, sex, ethnicity, language and employment will be collected and uploaded to a secure, password protected and centralized database hosted at Stellenbosch University. Standardized TB symptoms case report forms and medical history case report forms will be completed for all participants at each visit by the research nurse and recorded electronically via the tablet into the database. Information collected will include TB symptoms presence, severity and duration, previous TB episodes and treatment outcome, other medical conditions, medication use, HIV status (if known), previous surgery, family history, smoking history, alcohol consumption and recreational drug usage.
Study Procedures. For patients who completed Study RP103-03, study procedures include:
Study Procedures. All personnel performing surgical and/or follow-up assessments must be trained on Investigational device (LiquiBand FIX8®) usage and on this protocol (see section 5). Both the investigational (LiquiBand FIX8®) and control (AbsorbaTack™) devices must be used in accordance with their Instructions for Use (refer to appendix 9.2 and 9.3).
2.7.1 Summary of required clinical assessment and data collection Refer to schedule of assessments above (Table 2) for a summary of all required clinical assessments and data collection.
Study Procedures. Initially, only patients who completed Study RP103-03 will be enrolled into this long-term study. Additional patients who did not complete Study RP103-03 but qualify for RP103-04 based on current inclusion and exclusion criteria may be enrolled after completion of the analysis of the RP103-03 Study where the non-inferior efficacious and safe dose of RP103 versus Cystagon® has been determined. For patients who completed Study RP103-03, study procedures include: Screening The RP103-04 Screening visit occurs simultaneously with the RP103- 03 Period 2 Day 7 (End of Study) visit. These patients will continue RP103 Q12H treatment at the last dose level prescribed during their participation in Study RP103-03. Monthly Study Visits Study assessments will be made monthly (± 7 days) after study entry according to the Schedule of Events. A minimum of six (6) consecutive Monthly visits will be completed for each patient. Clinical laboratory assessments (hematology, chemistry, urinalysis), physical examination (including basic neurological and skin assessments) and xxxxx xxxxx, ECG, body weight, body mass index (BMI), body surface area (BSA), an Investigator administered will be made according to the Schedule of Events. During these visits, blood samples for PK (cysteamine) and PD (WBC cystine) will be collected 0.5 hour post RP103 dose administered at the clinic. Patients or parents will continue to maintain a daily diary, recording the dose and time, of cysteamine medications, proton pump inhibitors (PPI) and other gastric acid reducing drugs (prescription and over the counter medications). Patients or their parents will return their completed daily diary at each scheduled study visit and will receive a new or re- dispensed daily diary. Concomitant medications and adverse events will be collected. At or before each Monthly Visit, the Investigator will review available safety and PK/PD data and if a patient does not achieve an appropriate level of WBC cystine reduction or does not tolerate the dose, the patient may have their RP103 dose adjusted or may be terminated from the Study. This review will be documented in source and in the CRF as appropriate, with the action(s) taken and reasons for such action(s).