Screening After you sign and date the consent document, you will begin screening. The purpose of the screening is to find out if you meet all of the requirements to take part in the study. Procedures that will be completed during the study (including screening) are described below. If you do not meet the requirements, you will not be able to take part in the study. The study investigator or study staff will explain why. As part of screening, you must complete all of the items listed below: • Give your race, age, gender, and ethnicity • Give your medical history o You must review and confirm the information in your medical history questionnaire • Give your drug, alcohol, and tobacco use history • Give your past and current medication and treatment history. This includes any over-the-counter or prescription drugs, such as vitamins, dietary supplements, or herbal supplements, taken in the past 28 days • Height and weight will be measured • Physical exam will be done • Electrocardiogram (ECG) will be collected. An ECG measures the electrical activity of the heart • You may be tested for COVID-19 o Blood tests for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C o Blood tests to see how your blood clots ▪ Fibrinogen ▪ PT/INR/aPTT o Blood tests for amylase and lipase (enzymes that help with digestion, Part B only) o Blood tests for a lipid (fats) panel (Part B only) ▪ Total cholesterol ▪ Triglycerides ▪ HDL ▪ Direct HDL o Blood tests to check your thyroid function (Part B and Part C only) ▪ TSH ▪ Free T4 o Urine to test for drugs of abuse (illegal and prescription) o Urine tests to check your albumin/ creatinine ratio o Females who have not had a period for at least 12 months in a row will have a blood hormone test to confirm they cannot have children • The study investigator may decide to do an alcohol breath test • The use of proper birth control will be reviewed (males only) • You will be asked “How do you feel?” HIV, hepatitis B, and hepatitis C will be tested at screening. If anyone is exposed to your blood during the study, you will have these tests done again. If you have a positive test, you cannot be in or remain in the study. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS). If your HIV test is positive, you will be told about the results. It may take weeks or months after being infected with HIV for the test to be positive. The HIV test is not always right. Having certain infections or positive test results may have to be reported to the State Department of Health. This includes results for HIV, hepatitis, and other infections. If you have any questions about what information is required to be reported, please ask the study investigator or study staff. Although this testing is meant to be private, complete privacy cannot be guaranteed. For example, it is possible for a court of law to get health or study records without your permission.
Quality Management System Supplier hereby undertakes, warrants and confirms, and will ensue same for its subcontractors, to remain certified in accordance with ISO 9001 standard or equivalent. At any time during the term of this Agreement, the Supplier shall, if so instructed by ISR, provide evidence of such certifications. In any event, Supplier must notify ISR, in writing, in the event said certification is suspended and/or canceled and/or not continued.
Vulnerability Management BNY Mellon will maintain a documented process to identify and remediate security vulnerabilities affecting its systems used to provide the services. BNY Mellon will classify security vulnerabilities using industry recognized standards and conduct continuous monitoring and testing of its networks, hardware and software including regular penetration testing and ethical hack assessments. BNY Mellon will remediate identified security vulnerabilities in accordance with its process.
Quality Management Grantee will:
1. comply with quality management requirements as directed by the System Agency.
2. develop and implement a Quality Management Plan (QMP) that conforms with 25 TAC § 448.504 and make the QMP available to System Agency upon request. The QMP must be developed no later than the end of the first quarter of the Contract term.
3. update and revise the QMP each biennium or sooner, if necessary. Xxxxxxx’s governing body will review and approve the initial QMP, within the first quarter of the Contract term, and each updated and revised QMP thereafter. The QMP must describe Xxxxxxx’s methods to measure, assess, and improve -
i. Implementation of evidence-based practices, programs and research-based approaches to service delivery;
ii. Client/participant satisfaction with the services provided by Xxxxxxx;
iii. Service capacity and access to services;
iv. Client/participant continuum of care; and
v. Accuracy of data reported to the state.
4. participate in continuous quality improvement (CQI) activities as defined and scheduled by the state including, but not limited to data verification, performing self-reviews; submitting self-review results and supporting documentation for the state’s desk reviews; and participating in the state’s onsite or desk reviews.
5. submit plan of improvement or corrective action plan and supporting documentation as requested by System Agency.
6. participate in and actively pursue CQI activities that support performance and outcomes improvement.
7. respond to consultation recommendations by System Agency, which may include, but are not limited to the following:
i. Staff training;
ii. Self-monitoring activities guided by System Agency, including use of quality management tools to self-identify compliance issues; and
iii. Monitoring of performance reports in the System Agency electronic clinical management system.
Medical Verification The Town may require medical verification of an employee’s absence if the Town perceives the employee is abusing sick leave or has used an excessive amount of sick leave. The Town may require medical verification of an employee’s absence to verify that the employee is able to return to work with or without restrictions.
Virus Management DST shall maintain a malware protection program designed to deter malware infections, detect the presence of malware within DST environment.
Scaling “Scaling,” as used herein, involves:
System Logging The system must maintain an automated audit trail which can 20 identify the user or system process which initiates a request for PHI COUNTY discloses to 21 CONTRACTOR or CONTRACTOR creates, receives, maintains, or transmits on behalf of COUNTY, 22 or which alters such PHI. The audit trail must be date and time stamped, must log both successful and 23 failed accesses, must be read only, and must be restricted to authorized users. If such PHI is stored in a 24 database, database logging functionality must be enabled. Audit trail data must be archived for at least 3 25 years after occurrence.
Synchronization, Commissioning and Commercial Operation 4.1.1 The Power Producer shall give at least fifteen (15) days written notice to the SLDC / ALDC / DISCOM as the case may be, of the date on which it intends to synchronize the Power Project to the Grid System.
4.1.2 Subject to Article 4.1.1, the Power Project may be synchronized by the Power Producer to the Grid System when it meets all the connection conditions prescribed in the Grid Code and otherwise meets all other Indian legal requirements for synchronization to the Grid System.
4.1.3 The synchronization equipment and all necessary arrangements / equipment including Remote Terminal Unit (RTU) for scheduling of power generated from the Project and transmission of data to the concerned authority as per applicable regulation shall be installed by the Power Producer at its generation facility of the Power Project at its own cost. The Power Producer shall synchronize its system with the Grid System only after the approval of GETCO / SLDC / ALDC and GEDA.
4.1.4 The Power Producer shall immediately after each synchronization / tripping of generator, inform the sub-station of the Grid System to which the Power Project is electrically connected in accordance with applicable Grid Code.
4.1.5 The Power Producer shall commission the Project within SCOD.
4.1.6 The Power Producer shall be required to obtain Developer and/ or Transfer Permission, Key Plan drawing etc, if required, from GEDA. In cases of conversion of land from Agricultural to Non-Agriculture, the commissioning shall be taken up by GEDA only upon submission of N.A. permission by the Power Producer.
4.1.7 The Power Producer shall be required to follow the Forecasting and Scheduling procedures as per the Regulations issued by Hon’ble GERC from time to time. It is to clarify that in terms of GERC (Forecasting, Scheduling, Deviation Settlement and Related Matters of Solar and Wind Generation Sources) Regulations, 2019 the procedures for Forecasting, Scheduling & Deviation Settlment are applicable to all solar generators having combined installed capacity above 1 MW connected to the State Grid / Substation including those connected via pooling stations.
Configuration Management The Contractor shall maintain a configuration management program, which shall provide for the administrative and functional systems necessary for configuration identification, control, status accounting and reporting, to ensure configuration identity with the UCEU and associated cables produced by the Contractor. The Contractor shall maintain a Contractor approved Configuration Management Plan that complies with ANSI/EIA-649 2011. Notwithstanding ANSI/EIA-649 2011, the Contractor’s configuration management program shall comply with the VLS Configuration Management Plans, TL130-AD-PLN-010-VLS, and shall comply with the following:
