Clinical Laboratory Assessments Sample Clauses

Clinical Laboratory Assessments. Hematology, Coagulation, Blood Chemistry and Urinalysis data will be summarized by treatment group and visit. All clinical laboratory data will be converted to International System of Units (SI). Both raw and change from baseline values will be summarized by presenting the descriptive statistics by treatment group and visit. Central and local drug and alcohol test results and pregnancy tests results will be listed.
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Clinical Laboratory Assessments. The study physician will examine laboratory assessments gathered in screening for assessing participant eligibility. The study physician will use a list of normal ranges to conclude whether participants are eligible for the protocol, and will indicate justification for admitting participants with abnormal values, after consultation with the medical monitor. The following laboratory assessments will be performed as a part of screening Serum electrolytes and the metabolic profile, which includes: ALT/SGPT; albumin:globulin (A:G) ratio; albumin, serum; alkaline phosphatase, serum; AST/SGOT; bilirubin, total; BUN:creatinine ratio; calcium, serum; carbon dioxide; chloride, serum; creatinine, serum; globulin, total; glucose, serum; potassium, serum; protein, total, serum; sodium, serum; CBC, which includes: Hematocrit; hemoglobin;
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Clinical Laboratory Assessments. ‌‌‌ All continuous safety laboratory parameters will be summarized descriptively by absolute value at each visit by treatment group, together with the corresponding changes from baseline. Central laboratory reference ranges will be used to identify abnormalities with low, normal or high.
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Clinical Laboratory Assessments. All laboratory samples are to be obtained by venipuncture before study drug(s) administration. All analyses will be performed by the study central laboratory unless otherwise indicated Required clinical safety laboratory tests are as follows:
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Clinical Laboratory Assessments. Samples for hematology and clinical chemistry will be collected at Screening and at Hour 24. Screening assessments contributing to PELOD/PRISM/PIM2 scores must be collected within 6 hours prior to LJPC-501 administration (Section 10.4). All clinical laboratory assessments will be performed by the site’s local laboratory. Specific parameters to be measured are shown in Table 7. Refer to Table 4 for an outline of activities. Table 7: Clinical Laboratory and Biomarker Parameters Hematology Hemoglobin, hematocrit, platelets, and WBC Clinical Chemistry ALT, AST, ALP, total bilirubin, direct bilirubin, creatinine, BUN, phosphorus, glucose, albumin, calcium, bicarbonate, chloride, sodium, potassium, magnesium, PT, PTT, and INR Biomarkers Blood sample for angiotensin I and angiotensin II Pregnancy Serum pregnancy Abbreviations: ALP=alkaline phosphatase; ALT=alanine transaminase; ANC=absolute neutrophil count; AST=aspartate transaminase; BUN=blood urea nitrogen; INR=international normalized ratio; PT=prothrombin time; PTT=partial thromboplastin time; WBC=white blood cell.
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Clinical Laboratory Assessments. The PI will examine laboratory assessments gathered in screening for assessing subject eligibility. The PI will use a list of normal ranges to conclude whether subjects are eligible for the protocol, and will indicate justification for admitting subjects with abnormal values, after consultation with the medical monitor. The following laboratory assessments will be performed as a part of screening: • Serum electrolytes and metabolic profile o ALT/SGPT o Albumin:globulin (A:G) ratio o Albumin, serum o Alkaline phosphatase, serum o AST/SGOT o Bilirubin, total o BUN:creatinine ratio o Calcium, serum o Carbon dioxide o Chloride, serum o Creatinine, serum o Glucose, serum o Potassium, serum o Protein, total, serum o Sodium, serum • CBC o Hematocrit o Hemoglobin o MCV o MCH o MCHC o RDW o Percentage and absolute differential counts o RBC o Red blood cell count o White blood cell count • Urinalysis o Color o Appearance o Specific gravity o pH o Protein o Glucose o Ketones o Blood in urine o Leukocyte esterase o Nitrite • Thyroid function. o TSH high sensitivity o Free T4 o Free T3 • HIV serology. • Urine-dip pregnancy test for females of childbearing potential. • Urinary drug test will be performed. The clinical lab assessments and ECG will be performed by: LifeLabs Medical Laboratory Services 0000 Xxxxxxx Xxx Burnaby, BC, V5G 4V8
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Related to Clinical Laboratory Assessments

  • Diagnostic Assessment 6.3.1 Boards shall provide a list of pre-approved assessment tools consistent with their Board improvement plan for student achievement and which is compliant with Ministry of Education PPM (PPM 155: Diagnostic Assessment in Support of Student Learning, date of issue January 7, 2013).

  • Clinical 2.1 Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Laboratory Testing All laboratories selected by UPS Freight for analyzing Controlled Substances Testing will be HHS certified.

  • Conformity Assessment 1. The Parties recognize that a broad range of mechanisms exists to facilitate the acceptance of conformity assessment procedures and results thereby, including:

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

  • Trials The Ship shall run the following test and trials:

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • Drug Testing (A) The state and the PBA agree to drug testing of employees in accordance with section 112.0455, F.S., the Drug-Free Workplace Act.

  • Treatment Program Testing The Employer may request or require an employee to undergo drug and alcohol testing if the employee has been referred by the employer for chemical dependency treatment or evaluation or is participating in a chemical dependency treatment program under an employee benefit plan, in which case the employee may be requested or required to undergo drug or alcohol testing without prior notice during the evaluation or treatment period and for a period of up to two years following completion of any prescribed chemical dependency treatment program.

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