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

  • 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.

  • 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.

  • 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.

Related to Study Monitor

  • 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.

  • 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.

  • 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.

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

  • 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.

  • 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.