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
Sample 1

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 Investigator should forward all completed forms to the Study Monitor for review.

  • If any signs of drug toxicity are detected, they should also be documented and immediately reported to the Study Monitor, who will in turn notify the Study Director.

  • Note: If the Study Monitor does not think all required information has been provided, or forms have not been satisfactorily completed, he/she should contact the Investigator and rectify the situation before forwarding the package to the Study Director.

  • The Study Director will then review the worksheet, assign the approved treatment a Study Number, and then the online INAD database will notify both the Investigator and the Study Monitor of the assigned number and approval to proceed.

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

  • The Study Monitor will review the planned treatment (worksheet) and forward it to the Study Director at the AADAP Office.

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

  • It is essential that the Study Monitor has access to all documents, related to the study and the individual participants, at any time these are requested.

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.

  • Study Site means the location(s) under the control of the Institution where the Study is actually conducted as set out in Schedule 1.

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

  • Quality Surveillance Engineer / Inspector means any person appointed by or on behalf of the Purchaser to inspect or carry out quality surveillance on supplies, stores or work under the Contract or any person deputed by the Quality Surveillance Engineer for the said purpose.

  • Program Manager refers to the professional management firm selected by the Owner as the Owner’s representative for the Project, and its employees and consultants.

  • 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 has the meaning set forth in Section 3.1.

  • 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 person at Developer responsible for the project management of Product and identified in Schedule 2;

  • 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;