e-CRF Review and Query Management Sample Clauses

e-CRF Review and Query Management. In preparation for monitor visits, e-CRFs will be reviewed in-house, with particular reference to all medical data, such as SAEs, other patient safety items, patient suitability and protocol adherence. During monitoring and SDV, the MDS Pharma Services’ CRAs will ask the investigators for necessary clarifications, to rectify any errors or omissions detected and update the EDC system. MDS Pharma Services CRA will be also responsible for facilitating the resolution of all queries emitted by Data Management. These queries will be discussed with investigators during the course of a routine monitoring visit or by email/telephone.
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Related to e-CRF Review and Query Management

  • PERFORMANCE MANAGEMENT SYSTEM 5.1 The Employee agrees to participate in the performance management system that the Employer adopted for the employees of the Employer; 5.2 The Employee accepts that the purpose of the performance management system will be to provide a comprehensive system with specific performance standards to assist the employees and service providers to perform to the standards required; 5.3 The Employer must consult the Employee about the specific performance standards and targets that will be included in the performance management system applicable to the Employee; 5.4 The Employee undertakes to actively focus on the promotion and implementation of the key performance indicators (including special projects relevant to the employee’s responsibilities) within the local government framework; 5.5 The criteria upon which the performance of the Employee shall be assessed shall consist of two components, Operational Performance and Competencies both of which shall be contained in the Performance Agreement; 5.6 The Employee’s assessment will be based on his performance in terms of the outputs/outcomes (performance indicators) identified as per attached Performance Plan, which are linked to the KPAs, and will constitute 80% of the overall assessment result as per the weightings agreed to between the Employer and Employee; 5.7 The Competencies will make up the other 20% of the Employee’s assessment score. The Competencies are spilt into two groups, leading competencies (indicated in blue on the graph below) that drive strategic intent and direction and core competencies (indicated in green on the graph below), which drive the execution of the leading competencies. Strategic direc on and leadership People management Program and project management Financial management Change leadership Governance leadersip Moral competence Planning and organising Analysis and innova on Knowledge and informa on management Communica on Results and quality focus

  • Compliance Control Services (1) Support reporting to regulatory bodies and support financial statement preparation by making the Fund's accounting records available to the Trust, the Securities and Exchange Commission (the “SEC”), and the independent accountants. (2) Maintain accounting records according to the 1940 Act and regulations provided thereunder. (3) Perform its duties hereunder in compliance with all applicable laws and regulations and provide any sub-certifications reasonably requested by the Trust in connection with any certification required of the Trust pursuant to the Xxxxxxxx-Xxxxx Act of 2002 (the “SOX Act”) or any rules or regulations promulgated by the SEC thereunder, provided the same shall not be deemed to change USBFS’s standard of care as set forth herein. (4) Cooperate with the Trust’s independent accountants and take all reasonable action in the performance of its obligations under this Agreement to ensure that the necessary information is made available to such accountants for the expression of their opinion on the Fund’s financial statements without any qualification as to the scope of their examination.

  • Quality Control Program Engineer shall have a quality control program in place that ensures that all deliverable work is of high quality. Engineer shall submit a plan detailing its program to the Inspection Branch of the TxDOT Bridge Division for review and approval prior to beginning work. State may review or audit the programs.

  • Shareholder Internet Services The Transfer Agent shall provide internet access to the Fund’s shareholders through a designated web site (“Shareholder Internet Services”), which will be accessed by the Fund’s shareholders via a link on the Fund’s web site. The Shareholder Internet Services will be provided pursuant to established procedures and will allow shareholders to view their account information and perform certain on-line transaction request capabilities. The Shareholder Internet Services shall be provided at no additional charge, other than the transaction fees currently being charged for the different transactions as described on the Fee Schedule. The Transfer Agent reserves the right to charge a fee for this service in the future.

  • Financial Management System Subrecipient shall establish and maintain a sound financial management system, based upon generally accepted accounting principles. Contractor’s system shall provide fiscal control and accounting procedures that will include the following: i. Information pertaining to tuition rates, payments, and educational assistance payments; and

  • PERFORMANCE MONITORING AND REPORTING Performance indicators

  • Compliance Support Services Provide compliance policies and procedures related to services provided by BNY Mellon and, if mutually agreed, certain of the BNY Mellon Affiliates; summary procedures thereof; and periodic certification letters. · Such Compliance Support Services are administrative in nature and do not constitute, nor shall they be construed as constituting, legal advice or the provision of legal services for or on behalf of a Fund or any other person, and such services are subject to review and approval by the applicable Fund and by the Fund’s legal counsel. · Provide access to Fund records so as to permit the Fund or TRP to test the performance of BNY Mellon in providing the services under this Agreement. · Such Compliance Support Services performed by BNY Mellon under this Agreement shall be at the request and direction of the Fund and/or its chief compliance officer (the “Fund’s CCO”), as applicable. BNY Mellon disclaims liability to the Fund, and the Fund is solely responsible, for the selection, qualifications and performance of the Fund’s CCO and the adequacy and effectiveness of the Fund’s compliance program.

  • Enterprise Information Management Standards Performing Agency shall conform to HHS standards for data management as described by the policies of the HHS Chief Data and Analytics Officer. These include, but are not limited to, standards for documentation and communication of data models, metadata, and other data definition methods that are required by HHS for ongoing data governance, strategic portfolio analysis, interoperability planning, and valuation of HHS System data assets.

  • Cloud Computing State Risk and Authorization Management Program In accordance with Senate Bill 475, Acts 2021, 87th Leg., R.S., pursuant to Texas Government Code, Section 2054.0593, Contractor acknowledges and agrees that, if providing cloud computing services for System Agency, Contractor must comply with the requirements of the state risk and authorization management program and that System Agency may not enter or renew a contract with Contractor to purchase cloud computing services for the agency that are subject to the state risk and authorization management program unless Contractor demonstrates compliance with program requirements. If providing cloud computing services for System Agency that are subject to the state risk and authorization management program, Contractor certifies it will maintain program compliance and certification throughout the term of the Contract.

  • Quality Assurance Program An employee shall be entitled to leave of absence without loss of earnings from her or his regularly scheduled working hours for the purpose of writing examinations required by the College of Nurses of Ontario arising out of the Quality Assurance Program.

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