Data Review and Clarifications Sample Clauses

Data Review and Clarifications. A review of CRF data to the subject’s source data will be completed by the site monitor to ensure completeness and accuracy. After the CRFs have been completed, additional data clarifications and/or additions may be needed as a result of the data cleaning process. Data clarifications are documented and are part of each subject’s CRF.
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Data Review and Clarifications. Upon completion of the eCRFs, a targeted review of the eCRF data to the subject’s source data will be completed by the site monitor to ensure completeness and accuracy. Additional data clarifications and/or additions may be needed as a result of the data cleaning process. Data clarifications are documented and are part of each subject’s eCRFs.
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Data Review and Clarifications. Upon completion of the eCRFs, targeted data will be reviewed by the assigned Sponsor global clinical site management (CSM) team for accuracy and completeness. The planned source document verification and overall monitoring activities for this study are outlined in a separate document, the Protocol Monitoring Plan. Corrections and/or any necessary additions to the data will be applied and if required, queries will be generated. Designated investigative staff are expected to respond to data queries in a timely manner and ensure that the corrections and changes made to the data are reflected in the subjects’ source documentation. Deviations from this protocol, regulatory requirements and GCP must be recorded. An explanation of the deviation should be included, as applicable. In addition, corrective and preventive action should be identified, implemented and documented within the study records. Prior to study start, a plan for data validation will be completed by Alcon clinical data management, and agreed upon by the study clinical manager (CM) and other team members. Concomitant medications entered into the database will be coded using the WHO Drug Reference List. Medical history and adverse events will be coded using the medical dictionary for regulatory activities (MedDRA) terminology. Upon completion of the study and once the database is declared completed and accurate, the database will be locked and data will be available for data analysis. Any changes to the database after lock will be implemented upon agreement between the Sponsor’s clinical trial management, medical safety clinical data management and biostatistics departments, and will be completed following the Sponsor’s procedures for changes to a database after database lock.
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Data Review and Clarifications. Targeted eCRF data will be reviewed against the subject’s source data by the study monitors according to the SDV plan to ensure completeness and accuracy. After monitoring has occurred at the clinical sites and the eCRFs have been submitted, additional data clarifications and/or additions may be needed. Data clarifications and/or additions are documented and are part of each subject’s eCRFs.
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Related to Data Review and Clarifications

  • Ongoing Review and Revisions As set forth in Section 35.7, the Parties have agreed to the coordination and exchange of data and information under this Agreement to enhance system reliability and efficient market operations as systems exist and are contemplated as of the Effective Date. The Parties expect that these systems and the technology applicable to these systems and to the collection and exchange of data will change from time to time throughout the term of this Agreement. The Parties agree that the objectives of this Agreement can be fulfilled efficiently and economically only if the Parties, from time to time, review and, as appropriate, revise the requirements stated herein in response to such changes, including deleting, adding, or revising requirements and protocols. Each Party will negotiate in good faith in response to such revisions the other Party may propose from time to time. Nothing in this Agreement, however, shall require any Party to reach agreement with respect to any such changes, or to purchase, install, or otherwise implement new equipment, software, or devices, or functions, except as required to perform this Agreement.

  • 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.

  • Review Protocol A narrative description of how the Claims Review was conducted and what was evaluated.

  • Review of Submittals A/E and ODR review is only for conformance with the design concept and the information provided in the Contract Documents. Responses to submittals will be in writing. The approval of a separate item does not indicate approval of an assembly in which the item functions. The approval of a submittal does not relieve the Contractor of responsibility for any deviation from the requirements of the Contract unless the Contractor informs the A/E and ODR of such deviation in a clear, conspicuous, and written manner on the submittal transmittal and at the time of submission, and obtains the A/E’s and Owner’s written specific approval of the particular deviation.

  • Authorized User Overview and Mini-Bid Process Project Based IT Consulting Services Contracts enable Authorized Users to use a competitive Mini-bid Process to acquire Services on an as-needed basis, for qualified IT Projects. Project Based IT Consulting Services may include, but will not be limited to projects requiring: analysis, data classification, design, development, testing, quality assurance, security and associated training for Information Technology based applications. See section 1.3 Out of Scope Work for a listing of projects expressly excluded from the scope of this Contract. An Authorized User Agreement for Project Based IT Consulting Services will be governed first by the terms and conditions specified in the OGS Centralized Contract and second by terms and conditions added to the Authorized User Statement of Work. Additional terms and conditions shall not conflict with or modify the terms and conditions of the OGS Centralized Contract. NYS Executive Agencies must adhere to all internal processes and approvals including, as required, approval from NYS Office of Information Technology Services. Other Authorized Users must adhere to their own internal processes and approvals. In accordance with Appendix B, section 28, Modification of Contract Terms, an Authorized User may add additional required terms and conditions to this Mini-Bid and resultant Authorized User Agreement only if such terms and conditions (1) are more favorable to the Authorized User and (2) do not conflict with or supersede the OGS Centralized Contract terms and conditions. Examples of additional terms and conditions include: • Expedited delivery timeframe; • Additional incentives, such as discount for expedited payment/Procurement Card use; and • Any additional requirements imposed by the funding source or Federal law.

  • ADB’s Review of Procurement Decisions 9. All contracts procured under international competitive bidding procedures and contracts for consulting services shall be subject to prior review by ADB, unless otherwise agreed between the Borrower and ADB and set forth in the Procurement Plan. SCHEDULE 5

  • Review of Personnel Files Every member shall be allowed to review any of his/her personnel files except "confidential law enforcement records" and "trial preparation records" as defined in Ohio Revised Code Section 149.43 at any time, upon request and reasonable notice. Such request shall be made to the supervisor directly responsible for maintenance of such files. Review of the files shall be made in the presence of such supervisor or the supervisor's designated representative. For the Division master personnel file, the request shall be made to the member's Subdivision Deputy Chief or his/her designated representative. Any member, or the member's Lodge representative, may copy documents in the member's file. The City may levy a charge for such copying, which charge shall bear a reasonable relationship to actual costs. A member will be notified in writing any time records within his/her personnel, background, IAB, and/or payroll file(s) are requested, as a public records request pursuant to Ohio Revised Code Section 149.43, provided the City determines that the request is proper under applicable law. A member may request copies of any records provided under this paragraph, and these copies shall be provided at no cost to the member.

  • 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.

  • Review and Selection Process The Project Narratives of SAMHSA applications are peer-reviewed according to the evaluation criteria listed above. Decisions to fund a grant are based on the strengths and weaknesses of the application as identified by peer reviewers. The results of the peer review are advisory in nature. The program office and approving official make the final determination for funding based on the following: • Individual awards over $250,000 are approved by the Center for Mental Health Services National Advisory Council; • Availability of funds; • Equitable distribution of awards in terms of geography (including urban, rural, and remote settings) and balance among populations of focus and program size; • Submission of any required documentation that must be submitted prior to making an award; and • SAMHSA is required to review and consider any information about your organization that is in the Federal Award Performance and Integrity Information System (FAPIIS). In accordance with 45 CFR 75.212, SAMHSA reserves the right not to make an award to an entity if that entity does not meet the minimum qualification standards as described in section 75.205(a)(2). If SAMHSA chooses not to award a fundable application in accordance with 45 CFR 75.205(a)(2), SAMHSA must report that determination to the designated integrity and performance system accessible through the System for Award Management (XXX) [currently, FAPIIS]. You may review and comment on any information about your organization that a federal awarding agency previously entered. XXXXXX will consider your comments, in addition to other information in FAPIIS in making a judgment about your organization’s integrity, business ethics, and record of performance under federal awards when completing the review of risk posed as described in 45 CFR 75.205 HHS Awarding Agency Review of Risk by Applicants.

  • Review of Personnel File Upon written authority from an employee, OC shall permit the President of the Union or their designate to review that employee's personnel file in the office in which the file is normally kept in order to facilitate the proper investigation of a grievance.

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