Data Quality Pyramid

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Explanation of why high quality data (such as Good Laboratory Practice GLP) data is critical to regulation of pesticides. Shows the differences between GLP data and less robust linkage.

GLP Research and Data Quality Under several statutes, government requires Good Laboratory Practice (GLP) studies. Research must follow specified protocols with each step documented. Only GLP qualified facilities and personnel can be used. GLP research is demonstratively valid. In other words, if anyone wishes to conduct the research – then the results should be reproducible. An unintentional GLP violation can invalidate the study. An intentional GLP violation can be a criminal offense. If studies that make the headlines in the news media today were of GLP quality, quite likely the debate we are witnessing would not be occurring.

Data Quality Pyramid Utility Objectivity Transparency Integrity Quantity Consistency Objectivity Quantity Consistency Reliability Unknown Context Unknown Hypothetical Association Single Peer Reviewed Publication Repeated Peer Review Publications FIFRA Guideline Data Do not use Apply assessment factors to Evaluate Quality before using Increasing Uncertainty Scientific data has its transparency, objectivity, utility, consistency and integrity assured by GLP standards

Data Quality Pyramid for Risk Assessment Processes and Decisions FIFRA Guideline Data: Has its utility defined by FIFRA testing guidelines; has its consistency defined by EPA review; has its quantity defined by FIFRA data requirements; has its objectivity, transparency and integrity assured by GLP requirements. Repeated peer-reviewed publications: Has consistency defined by replication, demonstrates quantity based on the statistical design of the studies; has its objectivity from peer review; has utility to the extent it supports risk assessment; but loses its integrity and transparency because methods are not documented to the degree GLP requires. Single peer-reviewed publications: Has limited objectivity depending on the level of peer review but has its utility defined by one circumstance and may not have been designed for purposes of risk assessment; loses its transparency because methods are not documented to the degree GLP requires; loses its quantity by its isolation and is of unknown consistency . Hypothetical association: Has virtually no utility ; loses its objectivity to subjective speculation; has no transparency in methodological scientific application; is not supported by any quantity of data; and has no measure for consistency .

This document discusses developing an instrument to measure the quality of reporting for Lean Six Sigma projects in healthcare. It suggests that the quality of Lean Six Sigma project reporting is often poor, making it difficult to understand the methods and outcomes. It proposes using the AGREE II tool, which was designed to evaluate clinical practice guidelines, as a way to systematically evaluate the quality of reporting for Lean Six Sigma projects. Specifically, it would involve applying the AGREE II domains of scope, stakeholder involvement, rigor of development, clarity of presentation, applicability, and editorial independence to assess the quality of Lean Six Sigma project articles.

Fidelity DefinedUniversity of New Mexico

This document discusses ensuring fidelity when implementing programs. It defines fidelity as the degree to which programs are implemented as intended. It identifies several key aspects of fidelity including adherence (using appropriate materials and delivering to the right population), exposure (frequency and duration), quality of delivery, participation and responsiveness, and program differentiation. The document also provides resources for measuring fidelity such as observation tools and program-specific fidelity instruments.

Real-Life Compliance Solutions: Part IProlifiq Software

This document summarizes a webinar on real-life compliance solutions for disseminating promotional, scientific and educational content. The webinar agenda includes introductions, a presentation on the PACE process for material review, a discussion of preparing for regulatory inquiries and investigations, and a presentation on a digital communications history record system for compliance. The PACE process involves preparing materials for review, analyzing claims, categorizing materials, and executing the approval process. Having an electronic communications history record system allows companies to efficiently respond to regulatory inquiries, lower costs during litigation and investigations, and demonstrate a meaningful compliance program.

PipelineMark Fortner

2016 LabHIT VisionMegan Sawchuk

The document discusses the CDC's LabHIT program which aims to facilitate laboratory test ordering and reporting in electronic health records. The program develops and disseminates standardized terminology and code sets to support clinical data capture and interoperability. It also works with various stakeholders to engage in terminology development, promote semantic interoperability, and ensure usability and patient safety. The long-term goal is a single national reference database for recommended vocabulary sets to achieve full-scale interoperability for laboratory data.

M&E Systems for Evaluation: Where M meets Eremoved_62798267384a091db5c693ad7f1cc5ac

This document discusses how monitoring and evaluation (M&E) systems can support program evaluation through three case studies. It finds that while M&E systems may not replace randomized controlled trials, they can provide adequate evidence when integrated data from routine collection and surveys are analyzed together. Specifically, the document examines how M&E data has been used to evaluate the impact of a community health insurance scheme in Burkina Faso, a malaria partnership in Tanzania, and an HIV prevention program in India. In each case, the M&E system data provided plausible evidence of impact when analyzed longitudinally and through dose-response relationships, though the studies fell short of experimental evidence.

Interventions to Improve RHIS PerformanceRoutine Health Information NetwOrk (RHINO)

The document summarizes findings from a workshop on improving routine health information systems in Guanajuato, Mexico. It found that data accuracy was high at facility and district levels, but data completeness was low at facilities and high at districts. Timeliness was also low at facilities and moderate at districts. Many facilities lacked data collection procedures manuals and data quality checking mechanisms. While most facilities performed data analysis, comparisons between service types were lacking. Technical staff found existing systems user-friendly and comprehensive, but integration between vertical programs was limited. Confidence in data tasks was above average but interpretation and use of information was lower. Facilities met about half of governance criteria and one third of supervision standards. The document calls for small groups to propose interventions

Good Laboratory Practices and Safety AssessmentsPostgradoMLCC

This document discusses good laboratory practices (GLP) and their importance for evaluating chemical safety. It makes three key points: 1) GLP are based on fundamental scientific principles like using standardized methods, calibrated instruments, and making all data available for review. This provides scientific confidence in safety studies. 2) Non-GLP studies published in journals may be useful but also have limitations like less available data. GLP studies should be given more weight in regulatory decision making. 3) Factors like validation, replication, and independent evaluation of GLP studies increases regulators' confidence in results compared to non-GLP studies from journals alone.

Tonya 4.11 postsReModule 4 DQ 1What are the most effective .docxturveycharlyn

Tonya 4.1 1 posts Re:Module 4 DQ 1 What are the most effective strategies for managing quality control on qualitative methods in program evaluation? Why are they the most effective? Program evaluation can be difficult when there are various stakeholders involved with varying opinions as to what they what to gain from the evaluation process. Qualitative research allows us to look at the information on a deeper level. However, this type of evaluation needs to be mindful that it does not include researcher bias. As reported by Royse, Thyer, and Padgett (2016), during data collection and analysis, the researcher must resist the inevitable temptation to let personal bias or outside pressure influence. With any evaluation reliability, validity, and credibility are extremely important. In order to maintain ethical results one of the most effective ways to manage quality control on qualitative methods would be the use of triangulation. Triangulation uses multiple methods to ensure credibility and validity of the data being collected. As reported by Crump and Logan (2016), triangulation is achieved by intentionally using more than one method of gathering and analyzing data about the same phenomenon in order to seek convergence and corroboration and to eliminate the inherent biases from using only one method. By using triangulation the evaluator can assure that their data includes what the key stakeholders were seeking to find without any bias. Crump, B., & Logan, K. (2008). A Framework for Mixed Stakeholders and Mixed Methods. Electronic Journal Of Business Research Methods, 6(1), 21-28. Royse, D., Thyer, B. A., & Padgett, D. K. (2016). Program evaluation: An Introduction (6th ed.). Boston, MA: Cengage Learning. ISBN-13: 9781305101968 Reply | Quote & Reply ...

Developing a Systematic Review Eligibility Criteria - Leonard UzairueSystematic Reviews Network (SRN)

This document discusses study eligibility criteria for systematic reviews. It explains that eligibility criteria define the studies included in a review to ensure relevance, reliability, and validity while minimizing bias. Examples of criteria include population, intervention, country, study design, and population size. Criteria can be broad or narrow depending on the research question. The goals are to obtain adequate information while avoiding irrelevant literature. Bias can result from inappropriate criteria. Eligibility criteria should be tied to key elements like PICOTS and set before reviewing studies. Observational studies and non-English reports may provide additional relevant information.

O1natasharoyy

Blueprints to blue sky – analyzing the challenges and solutions for IHC compa...Candy Smellie

Manual assessment of biomarker expression is associated with significant inter- and intra reader variability. In some cases there are also limitations when it comes to sensitivity and specificity of manual biomarker assessment. In one example to the left, the “pure” contribution of inter-reader variability associated with Ki67 assessment was quantified across 20 tumors and 126 participating labs. In that study, it was demonstrated how image analysis can be used to significantly reduce inter-reader variability. In a another study, the National Danish Validation study of Her2, it was demonstrated how improved sensitivity/specificity of quantitative HER2 protein expression wrt gene amplification lead to significant cost savings in reflex testing. By automating aspects of stain quality control, it will become scalable to he point where EQA organizations may be able and willing to offer more frequent – perhaps even on-demand – proficiency testing and calibration services. It is possible that objective and quantitative standards will contribute to improve compliance with protocol recommendations. In clinical multi-center trials it will be easier to standardize and monitor data from each center. And it is our hope tha larger diagnostic pathology labs will be able to benefit from such a method by closely monitoring drift in staining quality for biomarkers.

360-Degree Feedback Reliability | Research Paper ReviewCRSystems

CJ 550 Module ThreVinaOconner450

CJ 550 Module Three Activity Guidelines and Rubric Overview: Understanding how data is collected is an important aspect of ensuring a research project’s or experiment’s overall validity. Research ethics is an integral part of any valid research finding. This research will potentially have a major impact on your decision as a leader within the criminal justice organization where you are employed. Therefore, it is vital to ensure proper findings by ethical data collection to minimize liability in your decisions. Prompt: Read the following real-world case study: The Kansas City Preventive Patrol Experiment. Then, read the following information on predictive policing: Evaluation of the Shreveport Predictive Policing Experiment. Think about the research and data collection methods used in both studies. Compare and contrast both methods. Identify ways in which the findings of the research experiments could be vulnerable to liability. Suggest alternative methods to minimize liability in the research findings. If no vulnerabilities can be identified, explain how the methods used in the research experiment preserved ethical and accurate findings. Specifically, the following critical elements must be addressed:  Compares and contrasts the data collection methods of two case studies  Identifies the vulnerabilities of the research findings and/or explains if methods used preserved ethical and accurate findings  Suggests alternative methods to limit liabilities Guidelines for Submission: Your paper must be submitted as a 2- to 3-page Microsoft Word document with double spacing, 12-point Times New Roman font, one-inch margins, and at least three sources cited in APA format. Critical Elements Exemplary (100%) Proficient (90%) Needs Improvement (70%) Not Evident (0%) Value Data Meets “Proficient” criteria and provides an exceptionally detailed comparison and contrast for the data collection of the two case studies Compares and contrasts the data collection methods of two case studies Compares and contrasts the data collection methods of two case studies but comparison lacks details Does not compare or contrast the data collection methods of two case studies 30 Vulnerabilities Meets “Proficient” criteria and provides exceptional detail in identifying the vulnerabilities of the research findings and/or explaining if methods used preserved ethical and accurate findings Identifies the vulnerabilities of the research findings and/or explains if methods used preserved ethical and accurate findings Identifies the vulnerabilities of the research findings and/or explains if methods used preserved ethical and accurate findings but explanation lacks details Does not identify the vulnerabilities nor explain if methods used preserved ethical and accurate findings of the research findings 30 Methods Meets “Proficient” criteria and provides exceptional details for suggesting alte ...

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NAAF Patient-Reported Outcomes ConsortiumNational Alopecia Areata Foundation

· Reflect on the four peer-reviewed articles you critically apprai.docxVannaJoy20

· Reflect on the four peer-reviewed articles you critically appraised in Module 4, related to your clinical topic of interest and PICOT. · Reflect on your current healthcare organization and think about potential opportunities for evidence-based change, using your topic of interest and PICOT as the basis for your reflection. · Consider the best method of disseminating the results of your presentation to an audience. The Assignment: (Evidence-Based Project) Part 4: Recommending an Evidence-Based Practice Change Create an 8- to 9-slide narrated PowerPoint presentation in which you do the following: · Briefly describe your healthcare organization, including its culture and readiness for change. (You may opt to keep various elements of this anonymous, such as your company name.) · Describe the current problem or opportunity for change. Include in this description the circumstances surrounding the need for change, the scope of the issue, the stakeholders involved, and the risks associated with change implementation in general. · Propose an evidence-based idea for a change in practice using an EBP approach to decision making. Note that you may find further research needs to be conducted if sufficient evidence is not discovered. · Describe your plan for knowledge transfer of this change, including knowledge creation, dissemination, and organizational adoption and implementation. · Explain how you would disseminate the results of your project to an audience. Provide a rationale for why you selected this dissemination strategy. · Describe the measurable outcomes you hope to achieve with the implementation of this evidence-based change. · Be sure to provide APA citations of the supporting evidence-based peer reviewed articles you selected to support your thinking. · Add a lessons learned section that includes the following: · A summary of the critical appraisal of the peer-reviewed articles you previously submitted · An explanation about what you learned from completing the Evaluation Table within the Critical Appraisal Tool Worksheet Template (1-3 slides) Zeinab Hazime Nurs 6052 10/16/2022 Evaluation Table Use this document to complete the evaluation table requirement of the Module 4 Assessment, Evidence-Based Project, Part 3A: Critical Appraisal of Research Full APA formatted citation of selected article. Article #1 Article #2 Article #3 Article #4 Abraham, J., Kitsiou, S., Meng, A., Burton, S., Vatani, H., & Kannampallil, T. (2020). Effects of CPOE-based medication ordering on outcomes: an overview of systematic reviews. BMJ Quality & Safety, 29(10), 1-2. Alanazi, A. (2020). The effect of computerized physician order entry on mortality rates in pediatric and neonatal care setting: Meta-analysis. Informatics in Medicine Unlocked, 19, 100308. https.

Lessons learned in using process tracing for evaluationremoved_62798267384a091db5c693ad7f1cc5ac

Assessing quality and bias in studiesILRI

This document discusses assessing quality and bias in studies. It defines quality as having two aspects: methodological quality, which relates to the design and conduct of the research, and reporting quality, which is how well the study is written to allow replication. Assessing bias focuses on potential systematic errors that could overestimate or underestimate effects. Several tools are used to evaluate risk of bias, consistency, precision, and publication bias. Guidelines also exist for transparent reporting in different study designs to improve quality. While quality assessment tools are available, they are not universally accepted and may lack external validation. Bias is a systematic error that should be evaluated in each study through domains like selection bias, information bias, and confounding.

Pharmaceutical Scientific and Regulatory Practices (12 April 2017)Obaid Ali / Roohi B. Obaid

This document discusses Pakistan's pharmaceutical regulatory practices and scientific issues. It identifies several areas for improvement, including organizational competency and pre/post-market reviews. It recommends simplifying regulations, conducting third-party inspections, and adopting emerging regulatory sciences to strengthen the system and keep the "wheel of change moving". The overall goal is to develop a regulatory framework that is science-based, risk-focused, and aligned with global standards.

Assessing ApplicabilityEffective Health Care Program

Study Eligibility Criteria QuizEffective Health Care Program

This document discusses study eligibility criteria for systematic reviews. It defines PICOTS as the key components to consider for criteria: Population, Intervention, Comparator, Outcome, Timing, and Setting. Study eligibility criteria should be determined before reviewing literature and applied consistently to avoid bias and ensure the reviewed studies can be appropriately compared. Well-constructed eligibility criteria based on PICOTS can help reviewers focus on the most relevant literature and answer the intended question.

Family planning 170706kristofferryan

This document discusses monitoring and evaluation concepts for family planning programs. It begins by outlining session objectives related to applying M&E frameworks, indicators, and issues to family planning programs from a post-Cairo perspective. It then provides an overview of topics to be covered including family planning frameworks, implications of the Cairo agenda, indicators like contraceptive prevalence and unmet need, monitoring quality of care, and linkages between family planning and HIV. The document reviews conceptual frameworks for understanding factors influencing fertility and family planning supply. It discusses applying these frameworks for M&E by examining inputs, outputs, outcomes, and impacts. Specific indicators, data sources, and issues related to monitoring quality of care, contraceptive prevalence, unmet need,

Bioanalytical Method Validation Fda PerspectiveDebanjan (Deb) Das

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Data Quality Pyramid

1. GLP Research and Data Quality Under several statutes, government requires Good Laboratory Practice (GLP) studies. Research must follow specified protocols with each step documented. Only GLP qualified facilities and personnel can be used. GLP research is demonstratively valid. In other words, if anyone wishes to conduct the research – then the results should be reproducible. An unintentional GLP violation can invalidate the study. An intentional GLP violation can be a criminal offense. If studies that make the headlines in the news media today were of GLP quality, quite likely the debate we are witnessing would not be occurring.

2. Data Quality Pyramid Utility Objectivity Transparency Integrity Quantity Consistency Objectivity Quantity Consistency Reliability Unknown Context Unknown Hypothetical Association Single Peer Reviewed Publication Repeated Peer Review Publications FIFRA Guideline Data Do not use Apply assessment factors to Evaluate Quality before using Increasing Uncertainty Scientific data has its transparency, objectivity, utility, consistency and integrity assured by GLP standards

3. Data Quality Pyramid for Risk Assessment Processes and Decisions FIFRA Guideline Data: Has its utility defined by FIFRA testing guidelines; has its consistency defined by EPA review; has its quantity defined by FIFRA data requirements; has its objectivity, transparency and integrity assured by GLP requirements. Repeated peer-reviewed publications: Has consistency defined by replication, demonstrates quantity based on the statistical design of the studies; has its objectivity from peer review; has utility to the extent it supports risk assessment; but loses its integrity and transparency because methods are not documented to the degree GLP requires. Single peer-reviewed publications: Has limited objectivity depending on the level of peer review but has its utility defined by one circumstance and may not have been designed for purposes of risk assessment; loses its transparency because methods are not documented to the degree GLP requires; loses its quantity by its isolation and is of unknown consistency . Hypothetical association: Has virtually no utility ; loses its objectivity to subjective speculation; has no transparency in methodological scientific application; is not supported by any quantity of data; and has no measure for consistency .

Data Quality Pyramid

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