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

  • If applicable, the Participating Organisation shall permit the Study Monitor and any Auditor or Inspector access to all relevant clinical data of the Non-Interventional Study Subjects for monitoring and source data verification, such access to be arranged at mutually convenient times and on reasonable notice.

  • 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.

  • 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.

  • 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.

  • Before the start of the monitoring or auditing visits, the Sponsor shall provide the Site Parties with the name of the appointed Study Monitor or auditor, and hereby warrants (in Dutch: “staat garant”) that such Study Monitor or Auditor shall timely sign a confidentiality statement regarding the above by means of a specific letter.

  • Immediately report all the adverse reactions, including the unexpected and serious adverse reactions, using the fastest means available, to the Study Monitor appointed by the Sponsor.

  • The study will be monitored by a Study Monitor approved by the Sponsor.

  • To the extent applicable, the Site Parties shall permit the Study Monitor, Auditor, IRB and any official with a legal right to inspect and access all relevant documentation and source data for monitoring of the progress of the Clinical Study, the proper collection and recording of Clinical Study data, and altogether the good quality of the Clinical Study and compliance with applicable Law.

  • PRA will make payments based on subject visits that have been source document verified by Study Monitor, in accordance with Exhibit B Budget.

  • If the temperature monitor has been out of range then the shipment should be placed into quarantine and the Sponsor and Study Monitor contacted immediately to determine whether the study vaccine may be used.

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;

  • 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;

  • Research record means any data, document, computer file, computer diskette, or any other written or non-written account or object that reasonably may be expected to provide evidence or information regarding the proposed, conducted, or reported research that constitutes the subject of an allegation of research misconduct. A research record includes, but is not limited to, grant or contract applications, whether funded or unfunded; grant or contract progress and other reports; laboratory notebooks; notes; correspondence; videos; photographs; X-ray film; slides; biological materials; computer files and printouts; manuscripts and publications; equipment use logs; laboratory procurement records; animal facility records; human and animal subject protocols; consent forms; medical charts; and patient research files.

  • 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;