Regulatory Knowledge and Support Sample Clauses

Regulatory Knowledge and Support. The Regulatory Knowledge and Support Component provides consultation, guidance, and investigator-focused regulatory tools, consultation, and training activities. It offers expertise and support in clinical research quality improvement activities. The team helps investigators learn how to prepare and maintain regulatory documents and interact with regulatory agencies. To advance study participant safety, research participant advocacy services and a data & safety monitoring resource are being developed. To date, we successfully established our consult service and developed the DSMP and research participant advocacy frameworks. We authored a CITI-based training module in cultural diversity and are in the process of developing additional training modules for clinical research coordinators and compliance topics. The Office of Regulatory Support and Quality Assurance provided seminars on regulatory issues. IRB Share is up and running at the University. Last, in collaboration with the Office of Regulatory Support and Quality Assurance, ¡Alianza!, and the Research Ethics and Research Training Components, we initiated a multi-CTSA effort to build a research coordinator career ladder, standardize job descriptions, and offer a concomitant training curriculum. This is a very high priority at our University voiced both by our Vice Xxxxxxx for Research and School of Medicine Executive Xxxx for Research and has been very well received by members in the CTSA Consortium. Metrics include:  # and profile of users of and satisfaction with consult and study participant advocacy services (process)  # and profile of training attendees (process)  # of training courses/seminars offered and user satisfaction with them (process)  Successful operationalization of study participant advocacy services (outcome)  Successfully implemented services and training related to regulatory activities (outcome)  Successful educational programs to improve knowledge of regulatory requirements (outcome)  Implementation of a Universal Consent form for participation in C/T research 8. ¡Alianza!, Miami Center for Research Participation and Partnership (MCRP2) In ¡Alianza! we are working to establish a network of centralized, affiliated locations for patient-oriented research. We are enhancing infrastructure to ensure highest ethical and regulatory standards and promote scholarly activity while accelerating the pace of research translation. We are also building a centralized core that will offer a...
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Related to Regulatory Knowledge and Support

  • TECHNOLOGY/KNOWLEDGE TRANSFER ACTIVITIES The goal of this task is to develop a plan to make the knowledge gained, experimental results, and lessons learned available to the public and key decision makers. The Recipient shall: • Prepare an Initial Fact Sheet at start of the project that describes the project. Use the format provided by the CAM. • Prepare a Final Project Fact Sheet at the project’s conclusion that discusses results. Use the format provided by the CAM. • Prepare a Technology/Knowledge Transfer Plan that includes: o An explanation of how the knowledge gained from the project will be made available to the public, including the targeted market sector and potential outreach to end users, utilities, regulatory agencies, and others.

  • REGULATORY FILINGS AND CAISO TARIFF COMPLIANCE 3.1 Filing

  • Background Investigations OSC policy requires that background investigations be conducted on Contractor Staff who will have access to OSC’s IT systems, access to OSC confidential information/data, or routine access to any OSC facility. For purposes of this policy, “routine access” is defined as access to an OSC facility for five consecutive business days or 10 business days over the annual term of the engagement. Accordingly, with the signing of this Agreement, the Contractor certifies that it has or will conduct a background investigation on Staff to whom the policy applies within the 12 months prior to the Staff commencing Services under this Agreement. The Contractor agrees to undertake a background investigation of any new/replacement Staff during the term of the Agreement. At a minimum, background investigations shall include a review/evaluation of the following: • identity verification, including Social Security Number search; • employment eligibility, including verification of U.S. citizenship or legal immigration status where appropriate; • criminal history/court records (Federal, State and local for the past five years); • work experience/history for the past five years; • pertinent skills, qualifications, and education/professional credentials; and • references. The Contractor must obtain the consent of its Staff to allow OSC, upon request: (i) to review the background investigation records, including all supporting documentation, and (ii) to conduct its own background investigation. Only Staff who have passed the background investigation, and provided such consent shall be assigned to provide Services to OSC under this Agreement. During the term of the Agreement, and in accordance with Appendix A (Section 10, Records), the Contractor must maintain records related to the background investigations performed.

  • Knowledge Management Collecting and processing data from multiple sources and generating information to support business requirements (e.g., information retrieval, information mapping/taxonomy, information sharing, categorization, knowledge engineering, knowledge capture/distribution/delivery, smart documents).

  • Documents & Data; Licensing of Intellectual Property This Agreement creates a non-exclusive and perpetual license for City to copy, use, modify, reuse, or sublicense any and all copyrights, designs, and other intellectual property embodied in plans, specifications, studies, drawings, estimates, and other documents or works of authorship fixed in any tangible medium of expression, including but not limited to, physical drawings or data magnetically, electronically or otherwise recorded or stored, which are prepared or caused to be prepared by Consultant under this Agreement (“Documents & Data”). All Documents & Data shall be and remain the property of City, and shall not be used in whole or in substantial part by Consultant on other projects without the City's express written permission. Within thirty (30) days following the completion, suspension, abandonment or termination of this Agreement, Consultant shall provide to City reproducible copies of all Documents & Data, in a form and amount required by City. City reserves the right to select the method of document reproduction and to establish where the reproduction will be accomplished. The reproduction expense shall be borne by City at the actual cost of duplication. In the event of a dispute regarding the amount of compensation to which the Consultant is entitled under the termination provisions of this Agreement, Consultant shall provide all Documents & Data to City upon payment of the undisputed amount. Consultant shall have no right to retain or fail to provide to City any such documents pending resolution of the dispute. In addition, Consultant shall retain copies of all Documents & Data on file for a minimum of five (5) years following completion of the Project, and shall make copies available to City upon the payment of actual reasonable duplication costs. In addition, before destroying the Documents & Data following this retention period, Consultant shall make a reasonable effort to notify City and provide City with the opportunity to obtain the documents.

  • Knowledge and Experience Buyer has such knowledge and experience in financial and business matters that it is capable of evaluating the merits and risks of the investment in the Securities.

  • Regulatory Matters The parties will negotiate in good faith to resolve regulatory criticisms or concerns expressed by the Office of the Comptroller of the Currency or other U.S. federal or state banking Regulators that can reasonably be addressed through a modification of the Agreement or adoption of mutually agreeable policies or procedures to prevent or resolve a Material Default described by clause (iii) of such definition, subject to applicable legal requirements including restrictions on disclosing confidential supervisory information.

  • BACKGROUND INVESTIGATION The BOARD is prohibited from knowingly employing a person who has been convicted of committing or attempting to commit certain criminal offenses. If the required criminal background investigation is not completed at the time this Contract is signed, and the subsequent investigation report reveals that there has been a prohibited conviction, this Contract shall immediately become null and void.

  • Education and Specialized Knowledge Preferably secondary school graduation; a good working knowledge of the Motor Vehicle Act and Regulations; a good knowledge of safety rules and regulations as they pertain to the driving and/or operation of the vehicles, equipment and machinery involved; preferably graduation from a defensive driving course and/or a recognized training program in the driving and operation of commercial type vehicle or heavy equipment.

  • Knowledge and Scholarship in Special Field Each certificated support person demonstrates a depth and breadth of knowledge of theory and content in the special field. He demonstrates an understanding of a knowledge about common school education and the educational milieu grades K12, and demonstrates the ability to integrate the area of specialty into the total school milieu, to wit:

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