Clinically significant lab values
[DOC File]DSMB Report Template
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All clinically significant lab values documented after the baseline assessment must be reported as an adverse event. Question Instruction At end of study only: check this box if participant experienced no adverse events At the end of the study, if the participant did not experience any adverse events throughout the study mark the ‘None’ box.
[DOC File]Template that can be copied and pasted to develop your own ...
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Any out of range lab values should have a notation of NCS or CS written next to them on the lab report itself. See the Source Documents section of these guidelines to ensure the lab report is accurately documented for this subject. ... All clinically significant abnormal test results will be repeated at appropriate intervals, as specified by ...
[DOC File]DSMB Report Template
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Listing 4: Clinically Significant Abnormal Lab Values by Site 28 * The final format of the reports, tables, and listings are to be determined by the Data and Safety Monitoring Board. Report Summary Protocol Synopsis. Project Organizational Chart, Personnel . Brief Statement of Purpose of Trial . Projected Timetable and Schedule
[DOC File]There has been confusion regarding grading of lab values ...
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Lab Results (remove lab boxes or rows that you do not choose to use for this case study) (NCLEX Client Need Category:Reduction of Risk Potential) CBC Current Most Recent WBC (4.5-11.0) HGB (12-16) PLTS (140-440) Neuts. % (42-72) Lymphs % (20-44) Identify the relevant lab results to this patient and their clinical significance:
[DOC File]eCRF Completion Guidelines - CyberChrome
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The clinically acceptable amount is ±5%. To bring the equipment-based inaccuracy to a clinically accepted level, the angle must be reduced to less than 10o, which yields ±5% deviation. As stated above, if the airflow transducer is within 5o of vertical, measured values are highly accurate – 0.60 ± …
[DOCX File]Laboratory Technical Manual, v 5.2
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Clinically significant GI, hepatic or renal disease. Psychosis failing to improve after exposure to 2 or more antipsychotic treatment s within the past 2 years. Imminent harm to self or others. Hospitalized for 14 or more days immediately before screening. Significant medical illness within 4 weeks of screening or persistently abnormal lab finding.
[DOC File]National PBM Monograph Template Rev20091005
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When should lab specimens that are collected by the nurse be labeled? (2012 National Patient Safety Goals—Identify patients correctly) Improve Staff Communication: If any of my patient’s lab results were “critical” or “panic values” what is the policy at my clinical site that guides me as to how quickly the physician must be notified?
[DOC File]DCP, Standard Operating Procedure, Reviewing and …
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May 17, 2010 · CTEP has become aware of uncertainty regarding the grading of lab values using CTCAE v4.0. Some of the confusion arises from the use of computer systems to grade numeric lab values. The rationale within CTCAE v4.0 was to apply more clinical significance to the descriptions of grade because of clinical management decisions that are made based on ...
Vol. 5, No. 1, January 2009 “Can You Handle the Truth?”
Listing 4: Clinically Significant Abnormal Lab Values 14 * Please note that the tables are numbered based on the corresponding Open session tables for consistency. Only tables that are applicable to Closed session need to be included here. The final format of the reports, tables, and listings are to be determined by the Data and Safety ...
[DOC File]LABORATORY REPORT COVER PAGE
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This patch enables multidivisional facilities to customize the number of labels required for each site in LABORATORY TEST File (#60) by adding two new fields that can be configured for a specific lab test at a specific facility: The INSTITUTION EXTRA LABELS field (#60.15,.01) and the NUMBER OF LABELS subfield (#60.15,1).
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