Clinical Monitoring Sample Clauses

Clinical Monitoring. The CTSN DCC will be responsible for Clinical Research Site monitoring and quality assurance of all data in accordance with the clinical monitoring plan. Monitoring will be done in compliance with current Good Clinical Practice Guidelines The CTSN DCC will communicate any clinically significant findings from clinical monitors to the NHLBI and Company in a timely manner.
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Clinical Monitoring. As this study is not a clinical trial, no clinical regulatory organisation will be involved in monitoring. We will comply to any monitoring requirements from the EDCTP.
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Clinical Monitoring. Oramed Medpace N/A Item Description
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Clinical Monitoring. Monitoring will be conducted by the Institution, NIH or their designee in compliance with applicable provisions of the FDA Good Clinical Practices. The Institution will communicate any clinically significant findings from clinical monitors to the Company in a timely manner.
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Clinical Monitoring. The NIAID will be responsible for Clinical Research Site monitoring and quality assurance of data in accordance with the clinical monitoring plan. Monitoring will be done in compliance with applicable provisions of the current ICH E6. The NIAID will communicate any clinically significant protocol violation findings from clinical monitors to the Company in a timely manner.” [COMMENT: If the Company will be performing quality audit visits add the following to 3.2: “The Company may perform quality audit visits and will coordinate those visits with [Insert appropriate Division, Office, NIAID] only if such audits are allowed and feasible under Sections 8 and 11.”]
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Clinical Monitoring. 3.2.1 The Company will be responsible for Clinical Research Site monitoring and quality assurance of all data in accordance with the clinical monitoring plan. Monitoring will be done in compliance with the current ICH E6. A clinical monitoring plan and site visit plan must be developed by the Company and submitted for review and comment to NIAID prior to initiation of the Clinical Trial. The Company must coordinate its clinical monitoring with NIAID. The Company will communicate significant Protocol violations or reports of insufficiencies from clinical monitors to NIAID in a timely manner. 3.2.2 NIAID may, during the term of this Agreement, conduct quality assurance audits of the clinical monitoring performed by the Company for this Clinical Trial and will coordinate those visits with the Company.”]
Sample 1
Clinical Monitoring. The Company will be responsible for Clinical Research Site monitoring and quality assurance of all data in accordance with the clinical monitoring plan. Monitoring will be done in compliance with the current ICH E6. A clinical monitoring plan and site visit plan must be developed by the Company and submitted for review and comment to NIAID prior to initiation of the Clinical Trial. The Company must coordinate its clinical monitoring with NIAID. The Company will communicate significant Protocol violations or reports of insufficiencies from clinical monitors to NIAID in a timely manner. NIAID may, during the term of this Agreement, conduct quality assurance audits of the clinical monitoring performed by the Company for this Clinical Trial. XXXXX must give the Company ten (10) calendar days’ notice in writing of any audit to be conducted under this Agreement. The NIAID audit will be at the cost of NIAID.
Sample 1
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Clinical Monitoring. Medpace operates in North America with a primarily centralized monitoring team of over 140 CRAs to promote greater standardization, cohesiveness, support, and stability. Each of the Medpace CRAs assigned to this project have monitoring experience and strong clinical backgrounds. The Clinical Safety will be managed by VIVUS or its designee. VIVUS Clinical Leader to be involved with casualty assignment for all Serious Adverse Events (SAEs).
Sample 1
Clinical Monitoring. (a) MIMC will assign a qualified Monitor to each Investigator Site. At the initiation visit, the Monitor will determine whether such site is fully equipped with the correct supply of investigational drugs, CRFs and other medical supplies and all forms necessary for proper implementation of the Protocol. At such time, the Monitor will discuss the Protocol with the Investigator, any on-site coordinator, and other members of Investigator's staff; will collect all necessary documentation for implementation of the study; and will provide such persons with a detailed outline of the procedures to be followed in executing the Protocol and conducting the Study. The Sponsor may choose to attend any such initiation visit as long as notice of such intent is provided to MIMC within one (1) week prior to the scheduled visit. (b) During the Study, all case report forms will be faxed to the offices of MIMC. In addition, the Monitor will visit the Investigator Site approximately [**] times per the requirements of the Protocol. The first of these site visits will occur after one to two (1 -2 ) patients have been enrolled in the Study and subsequently at study closeout. The final close-out visit will occur no later than [**] after the last patient has completed all Study requirements. During such visits, the Monitor will be responsible for reviewing each patient's CRF and other source documentation in order to determine: (i) continued acceptability of the Investigator Site as Study center; (ii) adherence to the Protocol; (iii) adherence to the current laws, rules and regulations regarding obligations to each patient and conduct of investigational studies; (iv) maintenance of adequate records with respect to patient identification, signed informed consents, clinical observations, drug receipt and disposition and any other records required to be maintained by the Protocol or laws, rules or regulations; and (v) reports submitted by each Investigator relating to the Study are timely, adequate and accurate. (c) The Sponsor, having given reasonable notice, may join with MIMC on its monitoring visit as deemed necessary. At any time during the conduct of the Study, however, the Sponsor, its agents and consultants, and representatives of applicable country regulatory agencies shall be permitted to inspect the Investigator Site, all pertinent patient records, and all other pertinent information pertaining to the Study. (d) After consultation with the Sponsor, MIMC shall withdraw the S...
Sample 1

Related to Clinical Monitoring

  • Program Monitoring The Contractor will make all records and documents required under this Agreement as outlined here, in OEC Policies and NHECC Policies available to the SRO or its designee, the SR Fiscal Officer or their designee and the OEC. Scheduled monitoring visits will take place twice a year. The SRO and OEC reserve the right to make unannounced visits.

  • Project Monitoring The Developer shall provide regular status reports to the NYISO in accordance with the monitoring requirements set forth in the Development Schedule, the Public Policy Transmission Planning Process Manual and Attachment Y of the OATT.

  • Contract Monitoring The criminal background checks required by this rule shall be national in scope, and must be conducted at least once every three (3) years. Contractor shall make the criminal background checks required by Paragraph IV.G.1 available for inspection and copying by DRS personnel upon request of DRS.

  • Evaluation, Testing, and Monitoring 1. The System Agency may review, test, evaluate and monitor Grantee’s Products and services, as well as associated documentation and technical support for compliance with the Accessibility Standards. Review, testing, evaluation and monitoring may be conducted before and after the award of a contract. Testing and monitoring may include user acceptance testing. Neither the review, testing (including acceptance testing), evaluation or monitoring of any Product or service, nor the absence of review, testing, evaluation or monitoring, will result in a waiver of the State’s right to contest the Grantee’s assertion of compliance with the Accessibility Standards. 2. Grantee agrees to cooperate fully and provide the System Agency and its representatives timely access to Products, records, and other items and information needed to conduct such review, evaluation, testing, and monitoring.

  • Compliance Monitoring Grantee must be subject to compliance monitoring during the period of performance in which funds are Expended and up to three years following the closeout of all funds. In order to assure that the program can be adequately monitored, the following is required of Grantee: a. Grantee must maintain a financial tracking system provided by Florida Housing that ensures that CRF funds are Expended in accordance with the requirements in this Agreement. b. Grantee must maintain records on all awards to Eligible Persons or Households. These records must include, but are not limited to: i. Proof of income compliance (documentation from submission month, including but not limited to paystub, Florida unemployment statement, social security and/or disability statement, etc.); ii. Lease; and iii. Documentation of rental assistance payments made.

  • EVALUATION AND MONITORING The ORGANIZATION agrees to maintain books, records and other documents and evidence, and to use accounting procedures and practices that sufficiently and properly support the complete performance of and the full compliance with this Agreement. The ORGANIZATION will retain these supporting books, records, documents and other materials for at least three (3) calendar years following the year in which the Agreement expires. The COUNTY and/or the State Auditor and any of their representatives shall have full and complete access to these books, records and other documents and evidence retained by the ORGANIZATION respecting all matters covered in and under this Agreement, and shall have the right to examine such during normal business hours as often as the COUNTY and/or the State Auditor may deem necessary. Such representatives shall be permitted to audit, examine and make excerpts or transcripts from such records, and to make audits of all contracts, invoices, materials, and records of matters covered by this Agreement. These access and examination rights shall last for three calendar years following the year in which the Agreement expires. The COUNTY intends without guarantee for its agents to use reasonable security procedures and protections to assure that related records and documents provided by the ORGANIZATION are not erroneously disclosed to third parties. The COUNTY will, however, disclose or make this material available to those authorized by/in the above paragraph or permitted under the provisions of Chapter 42.56 RCW without notice to the ORGANIZATION. The ORGANIZATION shall cooperate with and freely participate in any other monitoring or evaluation activities pertinent to this Agreement that the COUNTY finds needing to be conducted.

  • ANALYSIS AND MONITORING The Custodian shall (a) provide the Fund (or its duly-authorized investment manager or investment adviser) with an analysis of the custody risks associated with maintaining assets with the Eligible Securities Depositories set forth on Schedule B hereto in accordance with section (a)(1)(i)(A) of Rule 17f-7, and (b) monitor such risks on a continuing basis, and promptly notify the Fund (or its duly-authorized investment manager or investment adviser) of any material change in such risks, in accordance with section (a)(1)(i)(B) of Rule 17f-7.

  • Technical Cooperation In order to facilitate the implementation of this Agreement, developed country Members shall provide, on request and on mutually agreed terms and conditions, technical and financial cooperation in favour of developing and least-developed country Members. Such cooperation shall include assistance in the preparation of laws and regulations on the protection and enforcement of intellectual property rights as well as on the prevention of their abuse, and shall include support regarding the establishment or reinforcement of domestic offices and agencies relevant to these matters, including the training of personnel.

  • Monitoring Services IDT staff shall, using methods that include face-to-face and other contacts with the member, monitor the services a member receives. This monitoring shall ensure that: a. The member receives the services and supports authorized, arranged for and coordinated by the IDT staff; b. The services and supports identified in the MCP as being provided by natural and community supports are being provided; and c. The quality of the services and supports received is adequate and still necessary to continue to meet the needs and preferences of the member and support the member’s outcomes identified in the MCP.

  • Investigational Services This plan covers certain experimental or investigational services as described in this section. This plan covers clinical trials as required under R.I. General Law § 27-20-60. An approved clinical trial is a phase I, phase II, phase III, or phase IV clinical trial that is being performed to prevent, detect or treat cancer or a life-threatening disease or condition. In order to qualify, the clinical trial must be: • federally funded; • conducted under an investigational new drug application reviewed by the Food and Drug Administration (FDA); or • a drug trial that is exempt from having such an investigational new drug application. To qualify to participate in a clinical trial: • you must be determined to be eligible, according to the trial protocol; • a network provider must have concluded that your participation would be appropriate; and • medical and scientific information must have been provided establishing that your participation in the clinical trial would be appropriate. If a network provider is participating in a clinical trial, and the trial is being conducted in the state in which you reside, you may be required to participate in the trial through the network provider. Coverage under this plan includes routine patient costs for covered healthcare services furnished in connection with participation in a clinical trial. The amount you pay is based on the type of service you receive. Coverage for clinical trials does not include: • the investigational item, device, or service itself; • items or services provided solely to satisfy data collection and that are not used in the direct clinical management; or • a service that is clearly inconsistent with widely accepted standards of care.

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