Schedule of Study Procedures Sample Clauses

Schedule of Study Procedures. 9.1.1. Screening For patients who completed Study RP103-03: • The following data can be obtained from the RP103-03 Screening visit: o Demographics. o Medical history. o Medication history. o Menstrual history for females of childbearing potential. • The following data can be obtained from the RP103-03 Termination visit: o Clinical laboratory o Physical examination o 12-lead ECG o Xxxxx xxxxx • Dispense RP103 study medication. • Schedule return clinic visit for Monthly Visit 1. For patients who did not complete Study RP103-03: • Review inclusion/exclusion criteria. • Record demographics. • Record medical history. • Record medication history. • Record menstrual history for females of childbearing potential. • Perform a physical examination (see Section 9.10). • Obtain clinical laboratory samples (serum chemistry, hematology, and urinalysis, see Section 9.7). • Collect a cysteamine PK sample pre-dose RP103 administration. Actual collection time will be recorded. • Collect a WBC cystine PD sample pre-dose RP103 administration (which should be 5-6 hours post last Cystagon® administration). Actual collection time will be recorded. • Measure xxxxx xxxxx (blood pressure, heart rate, respiratory rate, and oral body temperature, see Section 9.11). • Obtain a 12-lead ECG (see Section 9.9). • Provide training for Daily Diary log of cysteamine and gastric acid reduction medications. Provide copy of daily medication diary. • Schedule return clinic visits for Days 1, 4 and 5. For all patients: • Obtain serum pregnancy test from females of childbearing potential. • Measure height and weight. • Calculate BMI and BSA (see Appendix 14.5). • • • Prepare subjects for study participation by informing them of study restrictions and procedures. • Provide copy of daily medications diary. • Record concomitant medications. • Monitor AEs. For patients whose Screening visit was > 7 days prior to Day 1, complete the following prior to RP103 dosing: • Re-assess inclusion/exclusion criteria. • Record any changes since Screening to medical history, medication history, menstrual history for females of childbearing potential. • Obtain serum pregnancy test from females of childbearing potential. • Measure height and weight. • Calculate BMI and BSA (see Appendix 14.5). • Perform a physical examination (see Section 9.10). • Collect a cysteamine PK sample pre-dose RP103 administration. Actual collection time will be recorded. • Collect a WBC cystine PD sample pre-dose RP103 administration. Actu...
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Related to Schedule of Study Procedures

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  • Billing Procedures (a) PROVIDER agrees all claims shall be submitted to OHCA in a format acceptable to OHCA and in accordance with the OHCA Provider Manual.

  • SAFETY PROCEDURES The Contractor shall:

  • 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.

  • RECOVERY PROCEDURES The nature and severity of any disaster will influence the recovery procedures. One crucial factor in determining how BellSouth will proceed with restoration is whether or not BellSouth's equipment is incapacitated. Regardless of who's equipment is out of service, BellSouth will move as quickly as possible to aid with service recovery; however, the approach that will be taken may differ depending upon the location of the problem.

  • ORDERING PROCEDURES 6.1 If the Authority or any Other Contracting Body decides to source the Services through this Services Framework then each Contracting Body shall be entitled at any time, during the Term to place an order for the Services from the Supplier by serving an Order in accordance with Framework Agreement Schedule 5 (Ordering Procedure).

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  • Testing Procedures Testing will be conducted by an outside certified Agency in such a way to ensure maximum accuracy and reliability by using the techniques, chain of custody procedures, equipment and laboratory facilities which have been approved by the U.S. Department of Health and Human Services. All employees notified of a positive controlled substance or alcohol test result may request an independent test of their split sample at the employee’s expense. If the test result is negative the Employer will reimburse the employee for the cost of the split sample test.

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