Managing Abnormal Laboratory Test Values Sample Clauses

Managing Abnormal Laboratory Test Values. All safety laboratory tests (haematology and blood biochemistry), for each visit time-point, should be captured in the database from the local laboratory and should not be reported as AEs unless specific treatment is given for the abnormality (e.g. a blood transfusion is given for a low haemoglobin) or a laboratory abnormality leads to further investigation and the diagnosis of a new clinical event (e.g. a high white cell count is found to be due to incidental leukaemia). In this event the clinical diagnosis should be reported on the AE form, not the laboratory abnormality leading to the diagnosis.
Sample 1
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Managing Abnormal Laboratory Test Values. All safety laboratory tests (hematology and blood biochemistry provided by the site for each visit time-point, should be captured in the database in the laboratory page and should not be reported as AEs even if qualified as `clinically significant` at site, unless specific treatment is given for the abnormality or if qualifying as grade 4 as per WHO recommendations. Treatment does not refer to platelets or RBC transfusions administered during conditioning and post HSCT or when patient has sign of HLH. If a laboratory abnormality leads to a new clinical diagnosis (e.g., high white cell count is found to be due to incidental leukemia), the new clinical diagnosis should be reported as an AE rather than the laboratory abnormality.
Sample 1

Related to Managing Abnormal Laboratory Test Values

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

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  • Substance Abuse Testing The Parties agree that it is in the best interest of all concerned to promote a safe working environment. The Union has no objection to pre-employment substance abuse testing when required by the Employer and further, the Union has no objection to voluntary substance abuse testing to qualify for employment on projects when required by a project owner. The cost and scheduling of such testing shall be paid for and arranged by the Employer. The Union agrees to reimburse the Employer for any failed pre-access Alcohol and Drug test costs.

  • 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.

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  • Product Quality 4.1 The following provisions shall apply to Product after Production:

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