Clinical Laboratory Assessments Sample Clauses

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. 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. 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. 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. ‌‌‌ 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. 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;
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Clinical Laboratory Assessments. The clinical laboratory evaluations to be performed in this trial are listed in Table 2. Those marked as screening tests will be performed at screening only. All other tests will be performed at Screening (Visit 1) and after 12 weeks of treatment (Visit 6), or Early Termination. Clinical laboratory values may be repeated prior to randomization in order to confirm exclusionary levels for TSH, ALT and/or AST values. If these values remain persistently elevated upon repeat, the patient is not eligible for randomization. With the exception of the urine pregnancy tests or the ad hoc urine drug test required at baseline for patients washing off excluded medications (e.g., opioids, benzodiazepines, amphetamines), all clinical laboratory evaluations will be analyzed via a central clinical laboratory, and information regarding appropriate sample volume, collection tubes, sample labeling and handling, and shipment will be provided in a study manual. A urine drug screen for drugs of abuse (including marijuana) will be collected at Screening Visit 1 and sent to the central laboratory for analysis. If the patient has a positive drug screen at Visit 1 and/or Visit 2 for anything other than marijuana, and the results cannot be explained by use of current allowable prescription medications, the patient should be excluded from the study. If the urine drug screen is positive at Visit 1 and the results can be explained by the use of current prescription medications (e.g., opioids, benzodiazepines, amphetamines) that will be discontinued during screening, the investigator must repeat the drug screen and obtain a negative result using an in-clinic urine dipstick drug screen prior to randomization to confirm eligibility for the study. Each clinically significant abnormal laboratory value or other clinically meaningful abnormality should be followed until the abnormality resolves or until a decision is made that it is not likely to resolve. If such abnormalities do not return to normal within a reasonable period, their etiology should be identified and Tonix or designee should be notified. Treatment-emergent clinically significant abnormalities in laboratory values will be recorded as AEs. Alanine aminotransferase (ALT)a Hematocrit Alkaline phosphatase Hemoglobin Aspartate aminotransferase (AST)a MCH concentration (MCHC) Bilirubin (total) Mean corpuscular hemoglobin (MCH) Blood urea nitrogen (BUN) Mean corpuscular volume (MCV) Calcium Platelet count Chloride Red blood cell (RBC)...
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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). 6.3.2 Teachers shall use their professional judgment to determine which assessment and/or evaluation tool(s) from the Board list of preapproved assessment tools is applicable, for which student(s), as well as the frequency and timing of the tool. In order to inform their instruction, teachers must utilize diagnostic assessment during the school year.

  • Clinical 1.1 Provides comprehensive evidence based nursing care and individual case management to a specific group of patients/clients including assessment, intervention and evaluation. 1.2 Undertakes clinical shifts at the direction of senior staff and the Nursing Director including participation on the on-call/after-hours/weekend roster if required. 1.3 Responsible and accountable for patient safety and quality of care through planning, coordinating, performing, facilitating, and evaluating the delivery of patient care relating to a particular group of patients, clients or staff in the practice setting. 1.4 Monitors, reviews and reports upon the standard of nursing practice to ensure that colleagues are working within the scope of nursing practice, following appropriate clinical pathways, policies, procedures and adopting a risk management approach in patient care delivery. 1.5 Participates in xxxx rounds/case conferences as appropriate. 1.6 Educates patients/carers in post discharge management and organises discharge summaries/referrals to other services, as appropriate. 1.7 Supports and liaises with patients, carers, colleagues, medical, nursing, allied health, support staff, external agencies and the private sector to provide coordinated multidisciplinary care. 1.8 Completes clinical documentation and undertakes other administrative/management tasks as required. 1.9 Participates in departmental and other meetings as required to meet organisational and service objectives. 1.10 Develops and seeks to implement change utilising expert clinical knowledge through research and evidence based best practice. 1.11 Monitors and maintains availability of consumable stock. 1.12 Complies with and demonstrates a positive commitment to Regulations, Acts and Policies relevant to nursing including the Code of Ethics for Nurses in Australia, the Code of Conduct for Nurses in Australia, the National Competency Standards for the Registered Nurse and the Poisons Act 2014 and Medicines and Poisons Regulations 2016. 1.13 Promotes and participates in team building and decision making. 1.14 Responsible for the clinical supervision of nurses at Level 1 and/or Enrolled Nurses/ Assistants in Nursing under their supervision.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • 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.

  • Tests and Preclinical and Clinical Trials The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

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

  • 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: (1) Harbour Acceptance Tests, including setting to work of the various equipment;

  • 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. (B) All classes covered by this Agreement are designated special risk classes for drug testing purposes. Special risk means employees who are required as a condition of employment to be certified under Chapter 633 or Chapter 943, F.S. (C) An employee shall have the right to grieve any disciplinary action taken under section 112.0455, the Drug-Free Workplace Act, subject to the limitations on the grievability of disciplinary actions in Article 10. If an employee is not disciplined but is denied a demotion, reassignment, or promotion as a result of a positive confirmed drug test, the employee shall have the right to grieve such action in accordance with Article 6.

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