Schedule of Study Procedures Sample Clauses

Schedule of Study Procedures. The tabular schedule of assessments is provided in Table 1. The study is comprised of a Screening, Washout, Pain Observation, Treatment, Safety Extension, and Follow-up period as outlined in the sections below.
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Schedule of Study Procedures. 9.1.1. Screening • 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 ▇▇▇▇▇ ▇▇▇▇▇ • Dispense RP103 study medication. • Schedule return clinic visit for Monthly Visit 1. • 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 ▇▇▇▇▇ ▇▇▇▇▇ (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. • 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. Actual collection time will be recorded. • Obtain clinical laboratory tests (serum chemistry, hematology, and urina...
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Related to Schedule of Study Procedures

  • Filing Procedures The Company shall (A) permit counsel to the Investor an opportunity to review and comment upon (i) each Registration Statement at least three (3) Trading Days prior to its filing with the SEC and (ii) all amendments and supplements to each Registration Statement (including, without limitation, the Prospectus contained therein) (except for Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and any similar or successor reports or Prospectus Supplements the contents of which is limited to that set forth in such reports) within a reasonable number of days prior to their filing with the SEC, and (B) shall reasonably consider any comments of the Investor and its counsel on any such Registration Statement or amendment or supplement thereto or to any Prospectus contained therein. The Company shall promptly furnish to the Investor, without charge, (i) electronic copies of any correspondence from the SEC or the staff of the SEC to the Company or its representatives relating to each Registration Statement (which correspondence shall be redacted to exclude any material, non-public information regarding the Company or any of its Subsidiaries), (ii) after the same is prepared and filed with the SEC, one (1) electronic copy of each Registration Statement and any amendment(s) and supplement(s) thereto, including, without limitation, financial statements and schedules, all documents incorporated therein by reference, if requested by the Investor, and all exhibits and (iii) upon the effectiveness of each Registration Statement, one (1) electronic copy of the Prospectus included in such Registration Statement and all amendments and supplements thereto; provided, however, the Company shall not be required to furnish any document to the extent such document is available on ▇▇▇▇▇).