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 6.1 The Performance Plan (Annexure A) to this Agreement sets out – 6.1.1 The standards and procedures for evaluating the Employee’s performance; and 6.1.2 The intervals for the evaluation of the Employee’s performance. 6.2 Despite the establishment of agreed intervals for evaluation, the Employer may in addition review the Employee’s performance at any stage while the contract of employment remains in force; 6.3 Personal growth and development needs identified during any performance review discussion must be documented in a Personal Development Plan as well as the actions agreed to and implementation must take place within set time frames; 6.4 The Employee’s performance will be measured in terms of contributions to the goals and strategies set out in the Employer’s Integrated Development Plan (IDP) as described in 6.6 – 6.12 below; 6.5 The Employee will submit quarterly performance reports (SDBIP) and a comprehensive annual performance report at least one week prior to the performance assessment meetings to the Evaluation Panel Chairperson for distribution to the panel members for preparation purposes; 6.6 Assessment of the achievement of results as outlined in the performance plan: 6.6.1 Each KPI or group of KPIs shall be assessed according to the extent to which the specified standards or performance targets have been met and with due regard to ad-hoc tasks that had to be performed under the KPI, and the score of the employer will be given to and explained to the Employee during the assessment interview. 6.6.2 A rating on the five-point scale shall be provided for each KPI or group of KPIs which will then be multiplied by the weighting to calculate the final score; 6.6.3 The Employee will submit his self-evaluation to the Employer prior to the formal assessment; 6.6.4 In the instance where the employee could not perform due to reasons outside the control of the employer and employee, the KPI will not be considered during the evaluation. The employee should provide sufficient evidence in such instances; and 6.6.5 An overall score will be calculated based on the total of the individual scores calculated above.

  • 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.

  • Monitoring Services IDT staff shall, using methods that include face-to-face and other contacts with the member, monitor the services a member receives. This monitoring shall ensure that: a. The member receives the services and supports authorized, arranged for and coordinated by the IDT staff; b. The services and supports identified in the MCP as being provided by natural and community supports are being provided; and c. The quality of the services and supports received is adequate and still necessary to continue to meet the needs and preferences of the member and support the member’s outcomes identified in the MCP.

  • 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

  • Enterprise Information Management Standards Grantee shall conform to HHS standards for data management as described by the policies of the HHS Office of Data, Analytics, and Performance. 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.

  • Program Services a) Personalized Care Practice agrees to provide to Program Member certain enhancements and amenities to professional medical services to be rendered by Personalized Care Practice to Program Member, as further described in Schedule 1 to these Terms. Upon prior written notice to Program Member, Personalized Care Practice may add or modify the Program Services set forth in Schedule 1, as reasonably necessary, and subject to such additional fees and/or terms and conditions as may be reasonably necessary. b) Program Member acknowledges that the Program Services are services that are not covered services under any insurance contract to which Program Member may be a party, including, without limitation, Medicare, and are not reimbursable by Program Member’s insurer, health plan or any governmental entity, including Medicare. Program Member agrees to bear sole financial responsibility for the Member Amenities Fee and agrees not to submit to Program Member’s insurer, health plan or governmental entity any xxxx, invoice or claim for payment or reimbursement of such Member Amenities Fee. c) Personalized Care Practice or its designated affiliate will separately charge Program Member or Program Member’s insurer, health plan or governmental entity for medical, clinical, diagnostic or therapeutic services rendered by Personalized Care Practice or its designated affiliate to Program Member, and Program Member may seek payment or reimbursement from Program Member’s insurer or health plan for any such service to the extent covered by Program Member’s insurer, health plan or governmental entity. d) Program Member understands, agrees and covenants that this Agreement is a service contract, and not a contract for insurance.

  • 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.

  • Customer Services Customer Relationship Management (CRM): All aspects of the CRM process, including planning, scheduling, and control activities involved with service delivery. The service components facilitate agencies’ requirements for managing and coordinating customer interactions across multiple communication channels and business lines. Customer Preferences: Customizing customer preferences relative to interface requirements and information delivery mechanisms (e.g., personalization, subscriptions, alerts and notifications).

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