Study Monitor definition

Study Monitor means one or more persons appointed by the Sponsor to monitor compliance of the Clinical Study with ICH-GCP and the Protocol and to conduct source data verification;
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Study Monitor means the individual appointed by the Sponsor/Grantor, as applicable, responsible for assuring the protection of Human Subjects, the accuracy and completeness of reported trial data, and the compliance of the trial with the protocol, good clinical practices and applicable regulations.75
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Examples of Study Monitor in a sentence

  • The Study Monitor is responsible for ensuring that all INAD procedures are being followed as defined by the Study Protocol.

  • If deviations occur, the Study Monitor should be notified immediately.

  • The Study Monitor must be notified as soon as possible if a participant does not begin protocol treatment as scheduled.

  • The FCCC Study Monitor will request case report forms to be completed within 2 weeks of the protocol visit.

  • Data review, coding and query processing will be done through interaction with the CTCC, site personnel and the Study Monitor.

  • The Study Monitor and Auditor’s access will be arranged at mutually convenient times and on reasonable notice with no additional costs for the Study Monitor, Auditor or Sponsor.

  • The Study Monitor and Auditor will comply with all internal policies and regulations of the Site Parties during such inspection, to the extent these are sufficiently communicated to the Study Monitor or Auditor.

  • In turn, the Study Monitor will adhere to all requirements for subject confidentiality as outlined in the ICF.

  • The Investigator and Investigator’s staff will be expected to cooperate with the Study Monitor, to be available during a portion of the monitoring visit to answer questions, and to provide any missing information.

  • For the avoidance of any doubt, the Sponsor shall be responsible for the confidential handling of all Personal Data of Clinical Study Subjects and other patients which the Study Monitor or Auditor comes across with during their monitoring or auditing activities.

Related to Study Monitor

  • Contract Monitor means the Department employee identified in Section 1.6 of the IFB as the Contract Monitor.

  • Interim Monitor means any monitor appointed pursuant to Paragraph III of this Order or Paragraph III of the related Order to Maintain Assets.

  • S&P CDO Monitor The dynamic, analytical computer model developed by S&P and used to calculate the default frequency in terms of the amount of debt assumed to default as a percentage of the original principal amount of the Collateral Obligations consistent with a specified benchmark rating level based upon certain assumptions (including the applicable S&P Minimum Weighted Average Recovery Rate) and S&P’s proprietary corporate default studies, as may be amended by S&P from time to time upon notice to the Issuer, the Trustee, the Collateral Manager and the Collateral Administrator. Each S&P CDO Monitor will be chosen by the Collateral Manager (with notice to the Collateral Administrator) and associated with either (x) an S&P Minimum Weighted Average Recovery Rate and an S&P Minimum Weighted Average Floating Spread from Section 2 of Schedule 4 or (y) an S&P Minimum Weighted Average Recovery Rate and an S&P Minimum Weighted Average Floating Spread confirmed by S&P, provided that as of any date of determination the Weighted Average S&P Recovery Rate for the Highest Ranking Class equals or exceeds the S&P Minimum Weighted Average Recovery Rate for such Class chosen by the Collateral Manager and the Weighted Average Floating Spread equals or exceeds the S&P Minimum Weighted Average Floating Spread chosen by the Collateral Manager. The model version of the S&P CDO Monitor is available at xxxxx://xxx.xx.xxxxxxxxxxxxxx.xxx.

  • Project Management Report means each report prepared in accordance with Section 4.02 of this Agreement;

  • Program Manager means the HCAI manager responsible for the grant program.

  • Project Manager means the principal employee or agent of the Recipient having administrative authority over the Project designated in Appendix B pursuant to Section VI hereof, or authorized designee as per written notification to the Director.

  • Evaluation Team means the team appointed by the City; “Information Meeting” has the meaning set out in section 2.2;

  • Project Leader shall have the meaning set forth in Section 2.1.

  • SRS means the scheme referred to by the Ministry of Finance as the Supplementary Retirement Scheme or such other scheme as shall replace or supersede the Supplementary Retirement Scheme from time to time.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Feedback means input regarding the SAP Products, services, business or technology plans, including, without limitation, comments or suggestions regarding the possible creation, modification, correction, improvement or enhancement of the SAP Products and/or services, or input as to whether Partner believes SAP’s development direction is consistent with their own business and IT needs.

  • Oversight means the term as it is defined in the Stewardship Agreement between CDOT and the FHWA.

  • Development Consent means the consent granted to the Development Application for the Development and includes all modifications made under section 4.55 of the Act.

  • The Works/Project means the works to be executed or done under this contract.

  • Project Managers means the individuals identified in Section 12 of this Agreement who are authorized by TriMet and Subrecipient respectively to send and receive communications regarding this Agreement.

  • CMC means Comprehensive maintenance Contract (labour, spare and preventive maintenance)

  • Monitor means the corporate body known as Monitor as provided by section 61 of the 2012 Act;

  • Study Completion means the database for the Study has been locked and all Essential Documents have been provided to the Sponsor, including a copy of the letter from the Reviewing HREC acknowledging receipt of the final report and/or closure letter from the Principal Investigator.

  • Clinical nurse specialist means a registered nurse with relevant post-basic qualifications and 12 months’ experience working in the clinical area of his/her specified post-basic qualification, or a minimum of four years’ post-basic registration experience, including three years’ experience in the relevant specialist field and who satisfies the local criteria.

  • Contractor Project Manager means the employee identified in a Statement of Work as the Contractor project manager.

  • Contract Manager means the DNR staff person who processes this contract, makes payments, provides and facilitates dispute resolution, provides technical advice to the Compliance Forester, and is the first point of contact for questions relating to this contract or interpretation of Work. The Contract Manager may perform the duties of the Compliance Forester.

  • Project Management Consultant means --------------Not Applicable --------------

  • Clean coal technology demonstration project means a project using funds appropriated under the heading “Department of Energy—Clean Coal Technology,” up to a total amount of $2,500,000,000 for commercial demonstration of clean coal technology, or similar projects funded through appropriations for the Environmental Protection Agency. The federal contribution for a qualifying project shall be at least 20 percent of the total cost of the demonstration project.

  • Project Management The individuals appointed by each Party cf. clause 4.1 in the Agreement.

  • Geotechnical engineer means a professional engineer registered with the Association of Professional Engineers, Geologists, and Geophysicists of the Northwest Territories and whose principal field of specialization is the design and construction of earthworks in a permafrost environment;

  • Project Engineer means the surveyor or engineer employed by or private