Clinical laboratory reference ranges
Haematology Reference Ranges
Reference ranges have been verified based on the local population. A sample of over 500 normal results was gathered and a mean and standard deviation for each parameter was obtained. Any outliers (>3.0 SD) were removed, and an upper and lower limit were obtained by …
[DOCX File]Office of Human Research - NYU Langone Health
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Laboratory reference ranges may vary from laboratory to laboratory; therefore, it is necessary to include documentation of the laboratory's normal range values. All updates to the laboratory ranges must also be maintained.
[DOCX File]ECOHSR | University of Pittsburgh
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For studies that use clinical laboratories for specimen testing, this section should include current a) laboratory reference ranges if the reference range is not on the laboratory report and b) laboratory certifications or accreditations, e.g., CAP, CLIA and PA DOH. Expired certifications and outdated reference ranges must be retained.
[DOC File]LABORATORY MANUAL - INTRODUCTION
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Reference Ranges. Coagulation. Prothrombin Time (PT) 9.0 ... Because of the wide variety of culture techniques now being used in the laboratory, clinical information must be adequate and the organ/site from which a specimen has been taken must be indicated on the request form. ... The Toxoplasma Reference Laboratory is based in the NPHS ...
[DOC File]The Directorate of Laboratory Medicine’s (DLM) pathology ...
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The Directorate of Laboratory Medicine (DLM) laboratories offer a comprehensive pathology service for research and clinical trials, and use only standardised validated testing platforms, methods and reference ranges for the duration of each study.
[DOCX File]Tool Summary Sheet: Clinical Monitoring Plan Template
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Clinical Monitoring Plan for protocol: ... phone screening area, subject visits, laboratory specimen collection, processing, and storage, investigational product (IP) storage, subject records and Regulatory Binder location, and monitoring workspace. ... Laboratory Reference Ranges. Trial Master File (TMF)
[DOCX File]Essential Regulatory Document Review Worksheet
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Reference ranges (as applicable) are present for each clinical laboratory in Section 4 of the Form FDA 1572 or S ection 5 of the Io R. Yes No The name of the laboratory is indicated on the laboratory referenc e ranges.
[DOC File]Pro7.1-02 SOP Checklist - Quality Management
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Comments: 6.3 Method Validation/Verification, Reportable Ranges, and Reference Intervals Additional information is also contained in the Validation SOP Checklist. Refer to the laboratory’s equipment-specific or validation SOP’s as needed to prevent duplication.
[DOCX File]Tool Summary Sheet: Clinical Monitoring Plan Template
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Laboratory Reference Ranges {if applicable; if not, remove} ... Review protocol required clinical and laboratory assessments. Review responsibility to review, sign, and follow-up on laboratory reports. Review guidelines for premature discontinuation of study participants.
THE OHIO STATE UNIVERSITY MEDICAL CENTER
Use either your laboratory’s specific form or instrument printouts. Either form must have the appropriate patient and required regulatory information. Ensure reference ranges are current if they are provided on the patient result report. Original copies of results will be kept in the laboratory.
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