STUDY MONITORING AND DATA COLLECTION Sample Clauses

STUDY MONITORING AND DATA COLLECTION. A representative from the Sponsor will visit the study center periodically to monitor adherence to the protocol and applicable FDA regulations, and the maintenance of adequate and accurate clinical records. CRFs are reviewed to ensure that key safety and efficacy data are collected and recorded as specified by the protocol. The Sponsor's representative (or designate) is permitted to access patient medical records, laboratory data and other source documentation as needed to appropriately monitor the trial.
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STUDY MONITORING AND DATA COLLECTION. A representative from the Sponsor will visit the study center periodically to monitor adherence to the protocol and applicable FDA regulations, and the maintenance of adequate and accurate clinical records. CRFs are reviewed to ensure that key safety and 103 November 16, 1999 Page 26 efficacy data are collected and recorded as specified by the protocol. The Sponsor's representative (or designate) is permitted to access patient medical records, laboratory data and other source documentation as needed to appropriately monitor the trial. 13.6 Disclosure of Data/Publication Individual patient medical information obtained as a result of this study is considered confidential and disclosure to third parties other than those noted below is prohibited. Such medical information may be given to the patient's personal physician or to other appropriate medical personnel responsible for the patient's welfare. Data generated as a result of this study are to be available for inspection on request by the FDA, the Sponsor or Sponsor's representative and by the Institutional Review Board. Presentation or publication of the study results is not permitted without prior submission to the Sponsor. It is anticipated that the final results of this study will be submitted to a peer-reviewed scientific journal. Authorship on such a paper will be acknowledged with customary scientific practice. 104 November 16, 1999 Page 27 14. REFERENCES 1. Lanxxx XX, Xurxxx X, Bolxxx X, et al: Cancer Statistics, 1999. CA Cancer J Clin 1999; 49: 8-31. 2. Metxxxx XX, Xurxxx XX, Xunxxxxxx XX, xt al: The national cancer data base report on race, age, and region variations in prostate cancer treatment. Cancer 1997; 80: 1261-1266. 3. Ragde H, Elgamal AA, Snow P, et al: ten-year disease free survival after transperineal sonography-guided Iodine-125 brachytherapy with or without 45-grax xxternal beam Irradiation in the treatment of patients with clinically localized, low to high Glexxxx xxade prostate carcinoma. Cancer 1998; 83: 989-1001. 4. Schxxxxxxxxx X, Shaxxxx X, Block N, et al: A controlled trial of bicalutamide versus flutamide, each in combination with leutinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate cancer. Urology 1995; 45: 745-752. 5. Vogelzang NJ: One hundred thirteen men with hormone-refractory prostate cancer died today. J Clin Oncol 1996; 14: 1753-1755. 6. Morxxx XX, Xosxxx X, Hoon DSB: Prolongation of survival in metastatic melanoma after active spe...
Sample 1
STUDY MONITORING AND DATA COLLECTION. The key sponsor contact, monitors, auditors, or regulatory inspectors are responsible for contacting and visiting the investigator for the purpose of inspecting the facilities and verifying source documents and records assuring that subject confidentially is respected. The monitor is responsible for source document verification of CRF data at regular intervals during the study. Protocol adherence, accuracy, and consistency of study conduct and data collection with respect to local regulations will be confirmed. Monitors will have access to subject records as identified in Section 13. By signing the Investigator’s Agreement, the investigator agrees to cooperate with the monitor to address and resolve issues identified during monitoring visits. In accordance with ICH/GCP and the audit plan, a site may be chosen for a site audit. A site audit would include, but is not limited to, an inspection of the facility(ies), review of subject and study-related records, and compliance with protocol requirements as well as ICH/GCP and applicable regulatory policies. All data will be collected in an electronic CRF system. All entries must be completed in English, and concomitant medications should be identified by tradenames. For further details surrounding the completion of CRFs, refer to the CRF completion guidelines.
Sample 1

Related to STUDY MONITORING AND DATA COLLECTION

  • Program Monitoring and Evaluation The Recipient shall prepare, or cause to be prepared, and furnish to the Association not later than six months after the Closing Date, a report of such scope and in such detail as the Association shall reasonably request, on the execution of the Program, the performance by the Recipient and the Association of their respective obligations under the Legal Agreements and the accomplishment of the purposes of the Financing.”

  • Monitoring and Review The Provider agrees to allow access to the Department for purposes of monitoring and review. This access includes but is not limited to client records, fiscal records, staffing records, policy and procedural manuals, facilities, staff, and children in care of the Department. The Department will conduct quality reviews, which may include site-based quality review visits.

  • Project Monitoring Reporting and Evaluation The Recipient shall furnish to the Association each Project Report not later than forty-five (45) days after the end of each calendar semester, covering the calendar semester.

  • 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.

  • 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.

  • 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.

  • 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.

  • Search, Enquiry, Investigation, Examination And Verification a. The Property is sold on an “as is where is basis” subject to all the necessary inspection, search (including but not limited to the status of title), enquiry (including but not limited to the terms of consent to transfer and/or assignment and outstanding charges), investigation, examination and verification of which the Purchaser is already advised to conduct prior to the auction and which the Purchaser warrants to the Assignee has been conducted by the Purchaser’s independent legal advisors at the time of execution of the Memorandum. b. The intending bidder or the Purchaser is responsible at own costs and expenses to make and shall be deemed to have carried out own search, enquiry, investigation, examination and verification on all liabilities and encumbrances affecting the Property, the title particulars as well as the accuracy and correctness of the particulars and information provided. c. The Purchaser shall be deemed to purchase the Property in all respects subject thereto and shall also be deemed to have full knowledge of the state and condition of the Property regardless of whether or not the said search, enquiry, investigation, examination and verification have been conducted. d. The Purchaser shall be deemed to have read, understood and accepted these Conditions of Sale prior to the auction and to have knowledge of all matters which would have been disclosed thereby and the Purchaser expressly warrants to the Assignee that the Purchaser has sought independent legal advice on all matters pertaining to this sale and has been advised by his/her/its independent legal advisor of the effect of all the Conditions of Sale. e. Neither the Assignee nor the Auctioneer shall be required or bound to inform the Purchaser of any such matters whether known to them or not and the Purchaser shall raise no enquiry, requisition or objection thereon or thereto.

  • Reporting and Monitoring Please provide a brief description of the mechanisms proposed for this project for reporting to the UNDP and partners, including a reporting schedule.

  • STATEWIDE CONTRACT MANAGEMENT SYSTEM If the maximum amount payable to Contractor under this Contract is $100,000 or greater, either on the Effective Date or at any time thereafter, this section shall apply. Contractor agrees to be governed by and comply with the provisions of §§00-000-000, 00-000-000, 00-000-000, and 00- 000-000, C.R.S. regarding the monitoring of vendor performance and the reporting of contract information in the State’s contract management system (“Contract Management System” or “CMS”). Contractor’s performance shall be subject to evaluation and review in accordance with the terms and conditions of this Contract, Colorado statutes governing CMS, and State Fiscal Rules and State Controller policies.

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