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
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Related to Procedures for Screening and Enrollment

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  • 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.

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