Laboratory Data. Clinical laboratory values will be expressed using SI units. For each arm, the actual value and change from baseline (Day 1, prior to the first administration of study drug) to each on study evaluation will be summarized for each clinical laboratory parameter, including hematology, and clinical chemistry. In the event of repeat values, the last non-missing value per study day/time will be used. In the event that Day 1 data are unavailable for a given patient/parameter, the screening value will substitute as the baseline value. Severity of select clinical lab measures will be determined using CTCAE criteria (e.g., those measures that have a corresponding CTCAE grade classification). Labs with CTCAE Grades ≥3 will be presented in a data listing. Shift tables that present changes from baseline to worst on- study and baseline to last on-study values relative to CTCAE classification ranges will be produced.
Laboratory Data. Laboratory data will be transferred electronically as described in Section 2.9.4. Once received, the data will be uploaded into the Consultant’s database, which uses Microsoft SQL 2000 software or equivalent. The data are tracked in the database using both laboratories identifiers and the sampling point labels.
Laboratory Data. Blood and urine samples for determination of clinical chemistry, haematology, and urinalysis will be taken at the times indicated in the Study Plan at the time points described in section 6.4.5 of the Clinical Study Protocol. The baseline value of each laboratory variable will be derived, as described in the Clinical Study Protocol, values captured 3 days before baseline visit will be considered as baseline value. If multiple records are present between -3 days and baseline visit then last value obtained prior to the first dose of medication will be considered as baseline. Alternatively, if two visits are equally eligible to assess patient status at baseline (e.g., two assessment at screening or baseline both prior to first dose with no w ashout or other intervention in the screening period), the average can be taken as a baseline value. The other post-baseline assessment non missing value lab parameter closest to the scheduled visit date, will be considered as visit value. The visit will be missing if no assessment was reported within the specified visit window around the scheduled date. If two assessments are equidistant from a scheduled visit, then the earlier of the two will be used. Designation of visits for Lab data assessment are given in table below intermittent dosing schedule (2/5) (Table 3a) Table 3a Day Ranges for LAB assessments Cycle No. Visit day Target day Day Range Screening -1 -28 – -1 1 Day 1 (Baseline) 1 1 1 Day 2 2 2 1 Day 3 3 3 - 6 1 Day 9 9 7 – 12 1 Day 16 16 13 – 19 1 Day 23 23 20 – 26 2 Day 2 30 27 – 33 2 Day 8 36 34 – 39 2 Day 15 43 40 – 46 2 Day 22 50 47 – 54 3 Day 2 58 55 – 72 4 Day 2 86 73 – 100 Y Day 2 X X-13 – X+14 Where Y = 5,6, …. And X=(Y-1)*28+2 Designation of visits for Lab data assessment are given in table below for intermittent dosing schedule (4/3) (Table 3b) Table 3b Day Ranges for LAB assessments Cycle No. Visit day Target day Day Range Screening -1 -28 – -1 1 Day 1 (Baseline) 1 -3 – 1 1 Day 2 2 2 – 3 1 Day 5 5 4 – 7 1 Day 9 9 8 – 12 1 Day 16 16 13 – 19 1 Day 23 23 20 – 26 2 Day 2 30 27 – 33 2 Day 8 36 34 – 39 Table 3b Day Ranges for LAB assessments Cycle No. Visit day Target day Day Range 2 Day 15 43 40 – 46 2 Day 22 50 47 – 54 3 Day 2 58 55 – 72 4 Day 2 86 73 – 100 Y Day 2 X X-13 – X+14 Where y = 5,6, …. And X=(Y-1)*28+2 For Serum/Plasma Glucose, Insulin and Insulin c-peptide measurement a visit window rules are defined in table 3c and 3d for respective dosing cohorts. Table 3c Day Ranges for Serum/Plasma Glucose...
Laboratory Data. The Laboratory QA Reviewers will be responsible for validation of laboratory project implementation measures of success. The QA Reviewer will be responsible for the submittal of data packages to the Project Manager to support the quality management plans in Appendix B and Appendix C.
Laboratory Data. Tabulate laboratory test results for inclusion in the geotechnical report, the report of tests sheet (Roadway Soil Survey Sheet), and for any necessary calculations and analyses.
Laboratory Data
