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<div style="float: left; margin: 0.5em 0.9em 0.4em 0em;">[[File:Fig1_Bellary_PerspectivesClinRes2014_5-4.jpg|220px]]</div>
<div style="float: left; margin: 0.5em 0.9em 0.4em 0em;">[[File:Fig1 Karaattuthazhathu NatJLabMed23 12-2.png|260px]]</div>
'''"[[Journal:Basics of case report form designing in clinical research|Basics of case report form designing in clinical research]]"'''
'''"[[Journal:Sigma metrics as a valuable tool for effective analytical performance and quality control planning in the clinical laboratory: A retrospective study|Sigma metrics as a valuable tool for effective analytical performance and quality control planning in the clinical laboratory: A retrospective study]]"'''


Case report form (CRF) is a specialized document in clinical research. It should be study protocol driven, robust in content and have material to collect the study specific data. Though paper CRFs are still used largely, use of electronic CRFs (eCRFs) are gaining popularity due to the advantages they offer such as improved data quality, online discrepancy management and faster database lock etc. Main objectives behind CRF development are preserving and maintaining quality and integrity of data. CRF design should be standardized to address the needs of all users such as investigator, site coordinator, study monitor, data entry personnel, medical coder and statistician. Data should be organized in a format that facilitates and simplifies data analysis. Collection of large amount of data will result in wasted resources in collecting and processing it and in many circumstances, will not be utilized for analysis. Apart from that, standard guidelines should be followed while designing the CRF. CRF completion manual should be provided to the site personnel to promote accurate data entry by them. ('''[[Journal:Basics of case report form designing in clinical research|Full article...]]''')<br />
For the release of precise and accurate reports of [[Medical test|routine tests]], its necessary to follow a proper [[quality management system]] (QMS) in the [[clinical laboratory]]. As one of the most popular QMS tools for process improvement, Six Sigma techniques and tools have been accepted widely in the [[laboratory]] testing process. Six Sigma gives an objective assessment of analytical methods and instrumentation, measuring the outcome of a process on a scale of 0 to 6. Poor outcomes are measured in terms of defects per million opportunities (DPMO). To do the performance assessment of each clinical laboratory [[analyte]] by Six Sigma analysis and to plan and chart out a better, customized [[quality control]] (QC) plan for each analyte, according to its own sigma value ... ('''[[Journal:Sigma metrics as a valuable tool for effective analytical performance and quality control planning in the clinical laboratory: A retrospective study|Full article...]]''')<br />
 
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Revision as of 16:52, 29 April 2024

Fig1 Karaattuthazhathu NatJLabMed23 12-2.png

"Sigma metrics as a valuable tool for effective analytical performance and quality control planning in the clinical laboratory: A retrospective study"

For the release of precise and accurate reports of routine tests, its necessary to follow a proper quality management system (QMS) in the clinical laboratory. As one of the most popular QMS tools for process improvement, Six Sigma techniques and tools have been accepted widely in the laboratory testing process. Six Sigma gives an objective assessment of analytical methods and instrumentation, measuring the outcome of a process on a scale of 0 to 6. Poor outcomes are measured in terms of defects per million opportunities (DPMO). To do the performance assessment of each clinical laboratory analyte by Six Sigma analysis and to plan and chart out a better, customized quality control (QC) plan for each analyte, according to its own sigma value ... (Full article...)
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