Procedures for Screening and Enrollment Sample Clauses

Procedures for Screening and Enrollment. (Visit 1) A signed and dated informed consent form will be obtained before screening procedures. Evaluations obtained as part of routine medical care and performed during the screening period may be used in place of the study-specific evaluations. Patients will acknowledge and agree to the possible use of this information for the study by giving informed consent. After informed consent is obtained, patients who are screened will be assigned a 6-digit patient identification number via IRT such that all patients from each center are given consecutive identification numbers in successive order of inclusion. The two first digits of the screening number will be the designated investigator country, the two following digits will be designated the center number, and the last 2 digits will be assigned at the investigator center (eg, the 3rd patient screened at center 5 in USA would be given the number of 010503). The screening visit (visit 1) will take place not more than 2 weeks before the baseline visit. An additional 14 days will be allowed for the receipt of data needed to confirm eligibility (eg, BILAG-2004, SLEDAI-2K, and PhGA central system assessment, laboratory results ….). The following procedures will be performed at visit 1: • obtain written informed consent • inclusion/exclusion criteria review; confirm that clinical SLEDAI-2K score is at least 6 • medical and psychiatric history review • physical examination (including measurement of height at screening only) • clinical laboratory tests • hepatitis B surface antigen [HBsAg], hepatitis C virus antibody [HCV Ab], XXX • anti-dsDNA Ab, C3, and C4 • hemolysis testing (Xxxxxx’ test only) • xxxxx xxxxx measurements (includes systolic and diastolic blood pressures, pulse, and temperature) • urine pregnancy test on all women regardless of childbearing potential • 12-lead ECG • concomitant medication review (at the start of screening) • adverse event inquiry • SLEDAI-2K • BILAG-2004 • SFI • SDI
Sample 1
AutoNDA by SimpleDocs

Related to Procedures for Screening and Enrollment

  • Mechanisms for Cooperation 1. Pursuant to Article 149 (Objectives), the Parties hereby establish a Committee on Cooperation comprising representatives of each Party. 2. The Parties will designate nationals contact points to facilitate communication on possible cooperation activities. The contact points will work with government agencies, business sector representatives and educational and research institutions for the operation of this Chapter. 3. The Parties shall use diplomatic channels to promote dialogue and cooperation consistent with this Agreement. 4. The Committee shall have the following functions: (a) to monitor and assess the progress in implementing of the cooperation projects agreed by the Parties; (b) to establish rules and procedures for the conduct of its work; (c) to make recommendations of the cooperation activities under this Chapter, in accordance with the strategic priorities of the Parties; and (d) to review through regular reporting from the Parties, the operation of this Chapter and the application and fulfillment of its objectives between the relevant institutions of the Parties.

  • Procedures for Surrender As promptly as practicable after the Effective Time, Parent shall cause the Paying Agent to mail to each holder of record of a certificate or certificates that represented Shares (the “Certificates”) or non-certificated Shares represented by book-entry (“Book-Entry Shares”), in each case, which Shares were converted into the right to receive the Merger Consideration at the Effective Time pursuant to this Agreement: (i) a letter of transmittal, which shall specify that delivery shall be effected, and risk of loss and title to the Certificates shall pass, only upon delivery of the Certificates to the Paying Agent, and shall otherwise be in such form and have such other provisions as Parent or the Paying Agent may reasonably specify, and (ii) instructions for effecting the surrender of the Certificates or Book-Entry Shares in exchange for payment of the Merger Consideration. Upon surrender of Certificates and Book-Entry Shares for cancellation to the Paying Agent or to such other agent or agents as may be appointed by Parent, and upon delivery of a letter of transmittal, duly executed and in proper form, with respect to such Certificates or Book-Entry Shares, the holder of such Certificates or Book-Entry Shares shall be entitled to receive the Merger Consideration for each Share formerly represented by such Certificates and for each Book-Entry Share. Any Certificates and Book-Entry Shares so surrendered shall forthwith be cancelled. If payment of the Merger Consideration is to be made to a Person other than the Person in whose name any surrendered Certificate is registered, it shall be a condition precedent of payment that the Certificate so surrendered shall be properly endorsed or shall be otherwise in proper form for transfer, and the Person requesting such payment shall have paid any transfer and other similar Taxes required by reason of the payment of the Merger Consideration to a Person other than the registered holder of the Certificate so surrendered and shall have established to the satisfaction of the Surviving Corporation that such Taxes either have been paid or are not required to be paid. Payment of the Merger Consideration with respect to Book-Entry Shares shall only be made to the Person in whose name such Book-Entry Shares are registered. Until surrendered as contemplated hereby, each Certificate or Book-Entry Share shall be deemed at any time after the Effective Time to represent only the right to receive the Merger Consideration in cash as contemplated by this Agreement, without interest thereon.

  • Procedures for Providing NP Through Full NXX Code Migration Where a Party has activated an entire NXX for a single Customer, or activated at least eighty percent (80%) of an NXX for a single Customer, with the remaining numbers in that NXX either reserved for future use by that Customer or otherwise unused, if such Customer chooses to receive Telephone Exchange Service from the other Party, the first Party shall cooperate with the second Party to have the entire NXX reassigned in the LERG (and associated industry databases, routing tables, etc.) to an End Office operated by the second Party. Such transfer will be accomplished with appropriate coordination between the Parties and subject to appropriate industry lead times for movements of NXXs from one switch to another. Neither Party shall charge the other in connection with this coordinated transfer.

  • Procedures for LNP Request The Parties shall provide for the requesting of End Office LNP capability on a reciprocal basis through a written request. The Parties acknowledge that Verizon has deployed LNP throughout its network in compliance with FCC 96-286 and other applicable FCC Regulations.

  • Program Monitoring and Evaluation (c) 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.”

  • Important Information About Procedures for Opening a New Account To help the government fight the funding of terrorism and money laundering activities, Federal law requires all financial organizations to obtain, verify, and record information that identifies each person who opens an account. What this means for you: When you open an account, you are required to provide your name, residential address, date of birth, and identification number. We may require other information that will allow us to identify you.

  • Procedures for Exercise The manner of exercising the Stock Option herein granted shall be by written notice to the Secretary of the Company at the time the Stock Option, or part thereof, is to be exercised, and in any event prior to the expiration of the Stock Option. Such notice shall state the election to exercise the Stock Option, the number of shares of Stock to be purchased upon exercise, the form of payment to be used, and shall be signed by the person so exercising the Stock Option.

  • Monitoring and Evaluation a. The AGENCY shall expeditiously provide to the COUNTY upon request, all data needed for the purpose of monitoring, evaluating and/or auditing the program(s). This data shall include, but not be limited to, clients served, services provided, outcomes achieved, information on materials and services delivered, and any other data required, in the sole discretion of the COUNTY, that may be required to adequately monitor and evaluate the services provided under this Contract. Monitoring shall be performed in accordance with COUNTY’S established Noncompliance Standards, a copy of which is attached hereto and incorporated by reference as Attachment “C”.

  • Procurement procedures 11.1 The Recipient must secure the best value for money and shall act in a fair, open and non-discriminatory manner in all purchases of goods and services.

  • Processing of Grievances (a) Shop stewards shall suffer no loss in pay for the time spent processing grievances or attending meetings with the Employer's representative.

Time is Money Join Law Insider Premium to draft better contracts faster.