Data Review by CRO Sample Clauses

Data Review by CRO. CRO and/or Pfizer will review the Study Data it receives on an ongoing basis. CRO and/or Pfizer will comply with applicable regulations requiring notification of participating investigators of new safety information about the Pfizer Drug (“Pfizer Drug” is the Pfizer product that is being studied) . CRO and/or Pfizer
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Data Review by CRO. CRO and/or Pfizer will review the Study Data it receives on an ongoing basis. CRO and/or Pfizer will comply with applicable regulations requiring notification of participating investigators of new safety information about the Pfizer Drug (“Pfizer Drug” is the Pfizer product that is being studied) . CRO and/or Pfizer further commits to notify Principal Investigator of any other new information of which CRO and/or Pfizer becomes aware that could affect the safety of the Study Subjects or influence the conduct of the Study. c. Kontrola údajů prováděná CRO. CRO nebo společnost Pfizer bude obdržené Studijní údaje průběžně kontrolovat. CRO nebo společnost Pfizer bude dodržovat platné předpisy stanovující povinnost informovat zúčastněné zkoušející o nových údajích o bezpečnosti Léčiva společnosti Pfizer („Léčivo společnosti Pfizer“ je přípravek společnosti Pfizer, který je předmětem hodnocení). . CRO nebo společnost Pfizer se dále zavazuje sdělit Hlavnímu zkoušejícímu veškeré další nové informace, které CRO nebo společnost Pfizer získá a které by mohly ovlivnit bezpečnost Subjektů studie nebo provádění Studie.

Related to Data Review by CRO

  • DATA REQUESTS Upon the written request of the District, the State Auditor’s Office, the Appraisal District, or the Comptroller during the term of this Agreement, the Applicant, the District or any other entity on behalf of the District shall provide the requesting party with all information reasonably necessary for the requesting party to determine whether the Applicant is in compliance with its rights, obligations or responsibilities, including, but not limited to, any employment obligations which may arise under this Agreement.

  • Data Retention The Company will hold and use the Data only as long as is necessary to implement, administer and manage the Grantee’s participation in the Plan, or as required to comply with legal or regulatory obligations, including under tax and security laws.

  • Log Reviews All systems processing and/or storing PHI COUNTY discloses to 11 CONTRACTOR or CONTRACTOR creates, receives, maintains, or transmits on behalf of COUNTY 12 must have a routine procedure in place to review system logs for unauthorized access.

  • Program Review The Contracting Officer or other authorized government representative may hold semi- annual program review meetings. Such meetings will be held via telecom or video teleconferencing. However, the Government reserves the right to request a meeting in person. The meetings will include all BPA holders, representatives from prospective customer agencies, a combination of current and prospective customer agencies, or individual BPA holders. Some Federal Government Agencies and any approved State, Local and Tribal agencies may establish a central program management function. Such users may require their primary suppliers to participate in agency program review meetings on a periodic basis, at no additional cost to the Government.

  • Inspection and Final Acceptance District may, at its discretion, inspect and accept or reject any of Consultant’s work under this Agreement, either during performance or when within sixty (60) days after submitted to District. If District does not reject work by a timely written explanation, Consultant’s work shall be deemed to have been accepted. District’s acceptance shall be conclusive as to such work except with respect to latent defects, fraud and such gross mistakes as amount to fraud. Acceptance of any of Consultant’s work by District shall not constitute a waiver of any of the provisions of this Agreement including, but not limited to indemnification and insurance provisions.

  • Validation Review In the event OIG has reason to believe that: (a) Good Shepherd’s Claims Review fails to conform to the requirements of this CIA; or (b) the IRO’s findings or Claims Review results are inaccurate, OIG may, at its sole discretion, conduct its own review to determine whether the Claims Review complied with the requirements of the CIA and/or the findings or Claims Review results are inaccurate (Validation Review). Good Shepherd shall pay for the reasonable cost of any such review performed by OIG or any of its designated agents. Any Validation Review of Reports submitted as part of Good Shepherd’s final Annual Report shall be initiated no later than one year after Good Shepherd’s final submission (as described in Section II) is received by OIG. Prior to initiating a Validation Review, OIG shall notify Good Shepherd of its intent to do so and provide a written explanation of why OIG believes such a review is necessary. To resolve any concerns raised by OIG, Good Shepherd may request a meeting with OIG to: (a) discuss the results of any Claims Review submissions or findings; (b) present any additional information to clarify the results of the Claims Review or to correct the inaccuracy of the Claims Review; and/or (c) propose alternatives to the proposed Validation Review. Good Shepherd agrees to provide any additional information as may be requested by OIG under this Section III.D.3 in an expedited manner. OIG will attempt in good faith to resolve any Claims Review issues with Good Shepherd prior to conducting a Validation Review. However, the final determination as to whether or not to proceed with a Validation Review shall be made at the sole discretion of OIG.

  • TIMELINESS OF BILLING SUBMISSION The parties agree that timeliness of billing is of the essence to this Contract and recognize that the City is on a fiscal year. All xxxxxxxx for dates of service prior to July 1 must be submitted to the City no later that the first Friday in August of the same year.

  • Data Analysis In the meeting, the analysis that has led the College President to conclude that a reduction- in-force in the FSA at that College may be necessary will be shared. The analysis will include but is not limited to the following: ● Relationship of the FSA to the mission, vision, values, and strategic plan of the College and district ● External requirement for the services provided by the FSA such as accreditation or intergovernmental agreements ● Annual instructional load (as applicable) ● Percentage of annual instructional load taught by Residential Faculty (as applicable) ● Fall Full-Time Student Equivalent (FFTE) inclusive of dual enrollment ● Number of Residential Faculty teaching/working in the FSA ● Number of Residential Faculty whose primary FSA is the FSA being analyzed ● Revenue trends over five years for the FSA including but not limited to tuition and fees ● Expenditure trends over five years for the FSA including but not limited to personnel and capital ● Account balances for any fees accounts within the FSA ● Cost/benefit analysis of reducing all non-Residential Faculty plus one Residential Faculty within the FSA ● An explanation of the problem that reducing the number of faculty in the FSA would solve ● The list of potential Residential Faculty that are at risk of layoff as determined by the Vice Chancellor of Human Resources ● Other relevant information, as requested

  • Project Review A. Programmatic Allowances

  • Design Review At appropriate stages of design, documented reviews of the design results shall be planned and conducted. Participants at each Design Review shall include representatives of all functions concerned with the design stage being reviewed, as well as other specialist personnel, as required. Records of such reviews shall be maintained. Any computer software used to perform alternative calculations or verify clearances through the use of scale models or computer-aided design and drafting (CADD) techniques shall be validated before the use of the application, with validation documented in accordance with Section 2.2.15. In addition, at each submittal to IFA for review, Developer shall provide hand calculations that validate any calculations performed by computer software.

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