SWP PHARMACEUTICALS, INC. - DATA MANAGEMENT PLAN
A Prospective, Multicenter, Randomized, Double-Blind, Phase 3 Clinical Study to Compare the Efficacy and Safety of XYZ Versus Corticosteroid for the Treatment of Lateral Epicondylitis (LE), Protocol Number ASUCNHI/XYZ-LE/16-17/001
Overview
21 CFR 312.50 spells out the responsibilities of the study sponsor in the management of clinical trial data and the verification of study data for completeness and accuracy. Thorough review of source data is important to ensure adequate protection of the rights, welfare, and safety of human subjects and the quality and integrity of the clinical investigation data. (FDA, 2013). Sponsor review of source data includes meeting the regulatory requirements for recordkeeping and data verification by use of the ALCOA principle. ALCOA is the acronym for the required components of data. These include:
A = Attributable: originator of the data; who entered the data; audit trail
L = Legible: human readable form, modifications should not obscure original data; audit trail
C = Contemporaneous: time of data entry should be close to when procedure performed; audit trail
O = Original: earliest record, modifications should not obscure original data; audit trail
A = Accurate: correct and complete; valid representation of source data, corrections documented, quality processes/measures used; audit trail.
SWP builds it data management plans around the ALCOA principles with the expectation that chosen study sites comply with ALCOA and the SWP Data Management Plan.
Definitions:
· Data Element - smallest unit of information collected on a clinical trial subject
· Data Originator – original source of the data; may be electronic or human; tied to the data element
· eCRF – electronic Case Report Form
· Source Data - original data (electronic or written)
· EDC - Electronic Data Capture System is provided by the sponsor, data base is created to collected subject data and follows the eCRF format. Data will be either manually entered into the EDC or transferred from a paper form and entered by an individual or automatic transmission from the device into the eCRF.
· Paper - paper forms used to collect subject data
· Electronic - data electronically transferred to the EDC such as EKG results, blood pressure monitors
· Data Element Identifiers – data that identifies the originator including log-in credentials, password, date, time, and subject tied to data.
· Access - Access to study data is limited to study staff who record the data, review the data, and enter the data. For the sponsor, the site monitor generally referred to as a Clinical Research Associate (CRA), statisticians, data entry and data management staff.
· Data Review -
· Data must be reviewed by the study site monitor to verify accuracy and completeness.
· Data reviewed by study coordinator
· Data reviewed by Data entry and data management staff
· Data entered into the EDC must be reviewed and electronically signed off by si.
Nursing Process (ADPIE) recopied from the original author of this ppt jeena.aejyJack Frost
The nursing process is a systematic problem-solving approach used by nurses to plan and provide care. It involves five steps: assessment, diagnosis, planning, implementation, and evaluation. Assessment involves continuously collecting subjective and objective data about a patient's health status through various methods like observation, interviews, and physical exams. This data is then organized, validated, and documented before moving to the diagnosis step. The nursing process ensures continuity of care and allows for individualized, collaborative, and outcome-focused care for patients.
The nursing process is a systematic problem-solving approach used by nurses to provide care. It involves five steps: assessment, diagnosis, planning, implementation, and evaluation. Assessment involves continuously collecting and organizing data through various methods like observation, interviews, and physical exams. This data is then validated and documented before moving to the diagnosis step to identify any health problems or needs.
Common abilities and fundamental potential checking out Environments history and comparison compensation for Diagnostic offerings Chart 1.3 checks blanketed by using Most insurance Carriers Methodology of checking out Interfering explanations ,keeping off mistakes proper preparation patient schooling , checking out Protocols sufferer Independence test, results Laboratory stories Margins of Error Ethics and the regulation patient's bill of Rights and sufferer obligations
The course deals with concepts, principles and techniques of health assessment, including history taking, physical examination, psychosocial assessment and interpreting laboratory findings to determine nursing diagnoses across the lifespan. The course outline covers the nursing process, data collection, documentation, assessment techniques, vital signs, physical exams and diagnostic procedures. Students will learn to analyze health assessments, utilize the nursing process, demonstrate critical thinking and accurately collect, classify and document subjective and objective data.
Overview of Patient Reported Outcomes in SAFTINet Marion Sills
This document discusses patient-reported outcomes (PROs) in the SAFTINet and PEC studies. It defines a PRO as a questionnaire collected directly from patients in clinical trials or settings. PROs can measure disease control and be used for screening, monitoring, feedback, decision-making, communication, and evaluating quality. The document outlines upcoming agenda items for meetings discussing how partners currently collect and use PROs, barriers to implementation, and potential use cases for an asthma PRO measure.
Jason LaRose has over 19 years of experience in emergency medical services as an EMT, paramedic student, and medical assistant. He has extensive skills in phlebotomy, EKG, intubation, and other medical procedures. Currently he works at ExamOne performing physical exams, vital signs, drug screens, and blood draws. He also has experience working for ambulance services and in clinical management roles at urgent care centers. LaRose is pursuing his paramedic certification and aims to expand his skills in pre-hospital emergency care.
Data Integrity in Decentralized Clinical Trials (DCTs)InsideScientific
Experts expand on the need for a comprehensive understanding of all sources of data in DCTs, and the need to evaluate those data centrally in real time to mitigate the risks associated with their capture (including data capture at the edge of the network (wearables)).
Every disruptive innovation must be complemented by adapted procedures, and this also applies to decentralized clinical trials (DCTs). Traditionally, sites entered clinical trial data in an Electronic Data Capture (EDC) system and these source data were verified at the site to confirm accuracy. Risk based monitoring focused on site level metrics such as screen failure rates, query rates, Serious Adverse Events (SAEs) reported, missed/late visits, etc. With DCTs, as source data are collected directly from participants this is no longer an option and a different approach is required to ensure the quality and integrity of the data. As a rule, a comprehensive understanding of all sources for data capture in a clinical trial and the process for centralization is essential. Also, it is important to evaluate the data collected in real time to allow early interventions that will ensure data integrity for regulatory submission.
In this webinar, Chitra Lele describes how centralized monitoring strategies can help aggregate and analyze data in real time and provide insights to a variety of functional teams across the trial continuum. Daniel Gutierrez describes how the Clinerion platform can boost data integrity in DCTs. The technology transforms global data sources to one query-able data model for structured medical data, while ensuring that the data keep its full resolution and integrity during aggregated queries.
Pierre Etienne talks about the expanding role of mobile Health Care Professionals (HCPs) and their crucial role in protecting data integrity. Clifton Chow finishes with a comparison of several artificial intelligence (AI) based binary classifiers for detecting the integrity of data obtained from Internet of Things (IoT) enabled wearable sensors.
Nursing Process (ADPIE) recopied from the original author of this ppt jeena.aejyJack Frost
The nursing process is a systematic problem-solving approach used by nurses to plan and provide care. It involves five steps: assessment, diagnosis, planning, implementation, and evaluation. Assessment involves continuously collecting subjective and objective data about a patient's health status through various methods like observation, interviews, and physical exams. This data is then organized, validated, and documented before moving to the diagnosis step. The nursing process ensures continuity of care and allows for individualized, collaborative, and outcome-focused care for patients.
The nursing process is a systematic problem-solving approach used by nurses to provide care. It involves five steps: assessment, diagnosis, planning, implementation, and evaluation. Assessment involves continuously collecting and organizing data through various methods like observation, interviews, and physical exams. This data is then validated and documented before moving to the diagnosis step to identify any health problems or needs.
Common abilities and fundamental potential checking out Environments history and comparison compensation for Diagnostic offerings Chart 1.3 checks blanketed by using Most insurance Carriers Methodology of checking out Interfering explanations ,keeping off mistakes proper preparation patient schooling , checking out Protocols sufferer Independence test, results Laboratory stories Margins of Error Ethics and the regulation patient's bill of Rights and sufferer obligations
The course deals with concepts, principles and techniques of health assessment, including history taking, physical examination, psychosocial assessment and interpreting laboratory findings to determine nursing diagnoses across the lifespan. The course outline covers the nursing process, data collection, documentation, assessment techniques, vital signs, physical exams and diagnostic procedures. Students will learn to analyze health assessments, utilize the nursing process, demonstrate critical thinking and accurately collect, classify and document subjective and objective data.
Overview of Patient Reported Outcomes in SAFTINet Marion Sills
This document discusses patient-reported outcomes (PROs) in the SAFTINet and PEC studies. It defines a PRO as a questionnaire collected directly from patients in clinical trials or settings. PROs can measure disease control and be used for screening, monitoring, feedback, decision-making, communication, and evaluating quality. The document outlines upcoming agenda items for meetings discussing how partners currently collect and use PROs, barriers to implementation, and potential use cases for an asthma PRO measure.
Jason LaRose has over 19 years of experience in emergency medical services as an EMT, paramedic student, and medical assistant. He has extensive skills in phlebotomy, EKG, intubation, and other medical procedures. Currently he works at ExamOne performing physical exams, vital signs, drug screens, and blood draws. He also has experience working for ambulance services and in clinical management roles at urgent care centers. LaRose is pursuing his paramedic certification and aims to expand his skills in pre-hospital emergency care.
Data Integrity in Decentralized Clinical Trials (DCTs)InsideScientific
Experts expand on the need for a comprehensive understanding of all sources of data in DCTs, and the need to evaluate those data centrally in real time to mitigate the risks associated with their capture (including data capture at the edge of the network (wearables)).
Every disruptive innovation must be complemented by adapted procedures, and this also applies to decentralized clinical trials (DCTs). Traditionally, sites entered clinical trial data in an Electronic Data Capture (EDC) system and these source data were verified at the site to confirm accuracy. Risk based monitoring focused on site level metrics such as screen failure rates, query rates, Serious Adverse Events (SAEs) reported, missed/late visits, etc. With DCTs, as source data are collected directly from participants this is no longer an option and a different approach is required to ensure the quality and integrity of the data. As a rule, a comprehensive understanding of all sources for data capture in a clinical trial and the process for centralization is essential. Also, it is important to evaluate the data collected in real time to allow early interventions that will ensure data integrity for regulatory submission.
In this webinar, Chitra Lele describes how centralized monitoring strategies can help aggregate and analyze data in real time and provide insights to a variety of functional teams across the trial continuum. Daniel Gutierrez describes how the Clinerion platform can boost data integrity in DCTs. The technology transforms global data sources to one query-able data model for structured medical data, while ensuring that the data keep its full resolution and integrity during aggregated queries.
Pierre Etienne talks about the expanding role of mobile Health Care Professionals (HCPs) and their crucial role in protecting data integrity. Clifton Chow finishes with a comparison of several artificial intelligence (AI) based binary classifiers for detecting the integrity of data obtained from Internet of Things (IoT) enabled wearable sensors.
These slides are from the Dartmouth Jones Lecture of May 2008 by Benjamin Littenberg. They describe the development and evaluation of the Vermedx Diabetes Information System
- The document describes a study that aims to analyze risk factors associated with postoperative pancreatic fistula following distal pancreatectomy.
- A sample size of at least 82 patients is needed based on previous studies. Data will be collected retrospectively over 8 years and prospectively over 3 years from patients undergoing distal pancreatectomy.
- Potential preoperative, intraoperative, and postoperative risk factors will be analyzed for their association with pancreatic fistula using statistical tests. A risk prediction model may be developed based on significant associated factors.
How Testing Standardization Reduced Charges for Solid Organ Transplant Patien...Kim Mahoney Hofmann
Improvement work isn’t easy, especially when it attempts to address rising health care costs. Solid organ transplant coordinator Sharon Ugolini and her team led award-winning work implementing new protocols for common tests. That led to more than just reduced patient charges, though — ordering appropriate tests increases value and quality, as well.
Infection and bone marrow suppression are common complications our solid organ transplant patients experience. Even though we routinely monitor those complications, we’ve found a lot of system-wide inconsistencies related to the lab work involved. These inconsistencies can lead to repetitive blood draws, delayed results and care, increased patient charges due to multiple lab visits to collect missed or incorrect tests, and patient dissatisfaction. Our objective was to investigate whether the implementation of protocols standardizing lab order sets could result in reduced charges for solid organ transplant recipients.
Nursing assessment is the systematic collection of data to identify a patient's health status and needs. It involves gathering both subjective and objective information from various sources including patient interviews, medical records, and examination. This data is organized using frameworks like Gordon's Functional Health Patterns and analyzed to understand the patient's condition, identify problems, and form the basis for an effective nursing care plan. The overall goal of assessment is to obtain a holistic view of the patient.
Tynesha Matthews is seeking a career in healthcare and has over 4 years of experience providing patient care. She has a background in medical research, customer service, and clinical work. Her experience includes assisting adults with developmental disabilities, working as an EMT and medical assistant, and conducting research on the effects of chemicals and the environment on DNA and the human thyroid.
This document discusses quality improvement in healthcare. It begins by posing questions about defining quality, what quality improvement is, and how quality can be improved. It then discusses the safety paradox in healthcare - that despite highly trained staff and technology, errors are common and patients are frequently harmed. Several studies on adverse event rates in hospitals are summarized. The document discusses concepts for safety and quality improvement like reliability, variation, measurement, and change management. It provides examples of quality improvement tools and approaches like process mapping, care bundles, measurement, and the PDSA (Plan-Do-Study-Act) cycle. Overall, the document provides an overview of key issues and approaches related to quality and safety in healthcare.
MeHI Regional Health IT Meetings - Worcester, MA - Nov, 2013MassEHealth
Presentation from the Massachusetts eHealth Institute Regional Health IT meeting in Worcester, MA in November, 2013. Featuring Larry Garber from Reliant Medical Group.
Brandon Brown is seeking employment as a Clinical Laboratory Scientist. He has over 5 years of experience working in hospital laboratories, including his current role as a Medical Technologist at Houston Methodist Hospital where he performs urinalysis, chemistry, coagulation, blood gas, and platelet testing. Brown has a Bachelor's degree in Medical Technology from the University of Arkansas and a Master's degree in progress from the University of Southern Mississippi. He has ASCP certification and references available.
This document describes a 5-year observational study to assess the long-term safety and effectiveness of etanercept (Enbrel) for the treatment of plaque psoriasis. The study will involve 2500 patients across 375 sites in the US and Canada. Patients will receive etanercept treatment determined by their physician and be evaluated every 6 months for 5 years. The primary objectives are to determine incidence rates of serious adverse events, serious infections, and malignancies. Secondary objectives include evaluating effectiveness outcomes using measures like Psoriasis Area and Severity Index. Data will be analyzed using descriptive statistics and Kaplan-Meier methodology.
This document contains the resume of Vanassa Kay Fultz. She has over 30 years of customer service experience and 7 years of experience in allied health fields. She is seeking a career in a healthcare facility where she can utilize her customer service and healthcare training. Her qualifications include strong communication, computer, and medical skills. Her education includes degrees in medical billing/coding and medical assisting. She has over 10 years of experience in roles such as medical records technician, health services coordinator, certified nurse assistant, and medical assistant.
Larry Garber, Medical Director for Informatics at Reliant Medical Group, presented on how the organization has used health information technology to improve quality, efficiency, and safety. Key points include:
- Reliant implemented an electronic health record system in 2007 that is now used by all physicians and staff.
- The EHR integrates with other technologies like patient portals, health information exchange, clinical decision support, and analytics tools.
- These technologies help improve care processes like diabetes and hypertension management, follow-up of abnormal test results, and medication management.
- The investments have helped lower Reliant's average annual costs per patient compared to other organizations in Massachusetts.
Actigraphy as a Metric in PAH Research and Clinical CareDuke Heart
Actigraphy devices can provide objective measures of physical activity and are being used more in PAH research and clinical care. Limitations of the 6-minute walk test include only providing a snapshot of function and not capturing daily fluctuations. Activity monitors continuously measure real-world activity levels and have been used in clinical trials to assess changes from baseline as primary or secondary endpoints. Emerging data suggest PAH patients have significantly reduced activity levels compared to controls and activity levels correlate with functional class and quality of life. Activity monitors may help evaluate therapeutic responses more sensitively than the 6-minute walk test alone.
Nursing Documentation (Sports Medicine Hospital) by: Nestor Salazar JrNestor Salazar
I would use Focus Charting to document the patient's nurses notes. There are several reasons why:
- Focus charting centers on the nursing process of assessment, planning, implementation and evaluation. This aligns well with how nurses approach patient care.
- It is flexible and can be adapted to any clinical setting. This allows it to work for different patient populations and care environments.
- Organizing notes by a focus, such as a symptom or behavior, makes the documentation easy to follow and the relevant information easy to find.
- Noting the patient's response to interventions helps evaluate the effectiveness of the care provided. This supports continuous improvement in nursing practice.
- The focus-data-action-response structure
11 Steps of the Nursing Process new 26 11 2018 (2).pptxMosaHasen
Here are some potential clusters from the data:
- Respiratory: difficulty breathing, increased respiratory rate
- Cardiovascular: increased pulse, elevated blood pressure
- Skin/tissue perfusion: lower extremity swelling
- Mobility: difficulty voiding
- Psychosocial: estranged from daughter, dislikes hospitals due to past experience
Some potential nursing diagnoses based on the clusters:
- Impaired gas exchange
- Acute pain
- Risk for deficient fluid volume
- Anxiety
- Readiness for enhanced coping
This document discusses the increasing pressure on healthcare providers to adhere to clinical guidelines and quality metrics. It outlines challenges in implementing clinical decision support systems and electronic medical records to help providers meet these demands. Key points include the need for provider buy-in, reliable guideline-based decision support, and creating a culture where metrics are accepted and do not cause anger or fear.
The nursing process is a systematic, cyclical approach to planning and providing patient care. It consists of five core phases - assessment, diagnosis, planning, implementation, and evaluation. Assessment involves collecting patient data through various methods like interviews, examinations, and record reviews. Diagnosis identifies the patient's actual or potential health problems. Planning develops goals and interventions. Implementation puts the care plan into action. Evaluation assesses the patient's response to interventions and progress toward goals. The nursing process provides structure and organization to nursing care and aims to promote optimal patient outcomes.
The document provides information and guidelines around evaluation and management documentation, including documentation of the chief complaint, history of present illness, review of systems, past medical history, physical exam, and medical decision making. It discusses the components needed for different levels of evaluation and management services and how to tally the level of service based on the history, exam, and medical decision making complexity.
The document discusses analyzing and improving the inpatient discharge process at a hospital. It outlines the current discharge process flow, collects data on discharge times, and identifies inefficiencies and their causes. Suggestions are made to standardize the process, improve communication and reduce non-value adding steps to decrease discharge times. A proposed discharge checklist model is presented to help streamline the process.
Pediatric Adverse Drug Events PresentationJordan Gamart
This document summarizes a webinar on pediatric adverse drug events hosted by the Patient Safety Movement Foundation. The webinar featured presentations from Dr. Anne Lyren on Children's Hospitals' Solutions for Patient Safety and Dr. James Broselow on eBroselow. Dr. Lyren discussed strategies to reduce pediatric adverse drug events through programs, checklists, and technology. Dr. Broselow discussed how assistive technologies can help standardize and simplify drug administration in pediatrics to reduce errors through features like dose verification and guidelines. The webinar provided an overview of initiatives and tools to help hospitals improve pediatric safety.
Assignment 1 Dealing with Diversity in America from Reconstructi.docxdeanmtaylor1545
Assignment 1: Dealing with Diversity in America from Reconstruction through the 1920s
For History 105: Dr. Stansbury’s classes (6 pages here)
Due Week 3 and worth 120 points. The formal deadline is Monday at 9am Eastern time, Jan. 21. But, due to the King holiday, no late penalty will be imposed if submitted by the end of Jan. 22.
[NOTE ON ECREE: The university is adopting a tool, called ecree for doing writing assignments in many classes. We will be using the ecree program for doing our papers in this class. More instructions on this tool will be posted. You are welcome to type your paper in MS-Word as traditionally done—and then to upload that file to ecree to revise and finish it up. Or, as we suggest, you may type your paper directly into ecree. When using ecree, you should use CHROME as your browser. As posted: “Please note that ecree works best in Firefox and Chrome. Please do not use Internet Explorer or mobile devices when using ecree.”]
BACKGROUND FOR THE PAPER: After the Civil War, the United States had to recover from war, handle western expansion, and grapple with very new economic forms. However, its greatest issues would revolve around the legacies of slavery and increasing diversity in the decades after the Civil War. In the South, former slaves now had freedom and new opportunities but, despite the Reconstruction period, faced old prejudices and rapidly forming new barriers. Immigrants from Europe and Asia came in large numbers but then faced political and social restrictions. Women continued to seek rights. Yet, on the whole, America became increasingly diverse by the 1920s. Consider developments, policies, and laws in that period from 1865 to the 1920s. Examine the statement below and drawing from provided sources, present a paper with specific examples and arguments to demonstrate the validity of your position.
Topic and Thesis Statement—in which you can take a pro or con position:
· Political policies and movements in the period from 1865 to the 1920s generally promoted diversity and “the melting pot” despite the strong prejudices of a few. (or you can take the position that they did not). Use specific examples of policies or movements from different decades to support your position.
After giving general consideration to your readings so far and any general research, select one of the positions above as your position—your thesis. (Sometimes after doing more thorough research, you might choose the reverse position. This happens with critical thinking and inquiry. Your final paper might end up taking a different position than you originally envisioned.) Organize your paper as follows with the four parts below (see TIPS sheet and TEMPLATE also), handling these issues:
1. The position you choose —or something close to it—will be the thesis statement in your opening paragraph. [usually this is one paragraph with thesis statement being the last sentence of the paragraph.]
2. To support your position, use thre.
Assignment 1 Why are the originalraw data not readily us.docxdeanmtaylor1545
Assignment 1
:
Why are the original/raw data not readily usable by analytics tasks? What are the main data preprocessing steps? List and explain their importance in analytics.
Refer to Chapter 3 in the attached textbook:
Sharda, R., Delen, D., Turban, E. (2020). Analytics, Data Science, & Artificial Intelligence: Systems for Decision Support 11E.
ISBN: 978-0-13-519201-6.
Discuss the process that generates the power of AI and discuss the differences between machine learning and deep learning.
Requirement:
****Separate document for each assignment.****
Minimum 300-350 words. Cover sheet, abstract, graphs, and references does not count.
Add references separately for each assignment question.
Double Spaced and APA 7th Edition Format
No plagiarized content please! Attach a plagiarized report.
Check for spelling and grammar mistakes!
$5 max. Please bid if you agree.
Assignment 2
:
What are the privacy issues with data mining? Do you think they are substantiated?
Refer to Chapter 4
in the attached textbook:
Sharda, R., Delen, D., Turban, E. (2020). Analytics, Data Science, & Artificial Intelligence: Systems for Decision Support 11E.
ISBN: 978-0-13-519201-6.
Requirement:
****Separate document for each assignment.****
Minimum 300-350 words. Cover sheet, abstract, graphs, and references does not count.
Add references separately for each assignment question.
Double Spaced and APA 7th Edition Format
No plagiarized content please! Attach a plagiarized report.
Check for spelling and grammar mistakes!
$5 max. Please bid if you agree.
.
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- A sample size of at least 82 patients is needed based on previous studies. Data will be collected retrospectively over 8 years and prospectively over 3 years from patients undergoing distal pancreatectomy.
- Potential preoperative, intraoperative, and postoperative risk factors will be analyzed for their association with pancreatic fistula using statistical tests. A risk prediction model may be developed based on significant associated factors.
How Testing Standardization Reduced Charges for Solid Organ Transplant Patien...Kim Mahoney Hofmann
Improvement work isn’t easy, especially when it attempts to address rising health care costs. Solid organ transplant coordinator Sharon Ugolini and her team led award-winning work implementing new protocols for common tests. That led to more than just reduced patient charges, though — ordering appropriate tests increases value and quality, as well.
Infection and bone marrow suppression are common complications our solid organ transplant patients experience. Even though we routinely monitor those complications, we’ve found a lot of system-wide inconsistencies related to the lab work involved. These inconsistencies can lead to repetitive blood draws, delayed results and care, increased patient charges due to multiple lab visits to collect missed or incorrect tests, and patient dissatisfaction. Our objective was to investigate whether the implementation of protocols standardizing lab order sets could result in reduced charges for solid organ transplant recipients.
Nursing assessment is the systematic collection of data to identify a patient's health status and needs. It involves gathering both subjective and objective information from various sources including patient interviews, medical records, and examination. This data is organized using frameworks like Gordon's Functional Health Patterns and analyzed to understand the patient's condition, identify problems, and form the basis for an effective nursing care plan. The overall goal of assessment is to obtain a holistic view of the patient.
Tynesha Matthews is seeking a career in healthcare and has over 4 years of experience providing patient care. She has a background in medical research, customer service, and clinical work. Her experience includes assisting adults with developmental disabilities, working as an EMT and medical assistant, and conducting research on the effects of chemicals and the environment on DNA and the human thyroid.
This document discusses quality improvement in healthcare. It begins by posing questions about defining quality, what quality improvement is, and how quality can be improved. It then discusses the safety paradox in healthcare - that despite highly trained staff and technology, errors are common and patients are frequently harmed. Several studies on adverse event rates in hospitals are summarized. The document discusses concepts for safety and quality improvement like reliability, variation, measurement, and change management. It provides examples of quality improvement tools and approaches like process mapping, care bundles, measurement, and the PDSA (Plan-Do-Study-Act) cycle. Overall, the document provides an overview of key issues and approaches related to quality and safety in healthcare.
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Brandon Brown is seeking employment as a Clinical Laboratory Scientist. He has over 5 years of experience working in hospital laboratories, including his current role as a Medical Technologist at Houston Methodist Hospital where he performs urinalysis, chemistry, coagulation, blood gas, and platelet testing. Brown has a Bachelor's degree in Medical Technology from the University of Arkansas and a Master's degree in progress from the University of Southern Mississippi. He has ASCP certification and references available.
This document describes a 5-year observational study to assess the long-term safety and effectiveness of etanercept (Enbrel) for the treatment of plaque psoriasis. The study will involve 2500 patients across 375 sites in the US and Canada. Patients will receive etanercept treatment determined by their physician and be evaluated every 6 months for 5 years. The primary objectives are to determine incidence rates of serious adverse events, serious infections, and malignancies. Secondary objectives include evaluating effectiveness outcomes using measures like Psoriasis Area and Severity Index. Data will be analyzed using descriptive statistics and Kaplan-Meier methodology.
This document contains the resume of Vanassa Kay Fultz. She has over 30 years of customer service experience and 7 years of experience in allied health fields. She is seeking a career in a healthcare facility where she can utilize her customer service and healthcare training. Her qualifications include strong communication, computer, and medical skills. Her education includes degrees in medical billing/coding and medical assisting. She has over 10 years of experience in roles such as medical records technician, health services coordinator, certified nurse assistant, and medical assistant.
Larry Garber, Medical Director for Informatics at Reliant Medical Group, presented on how the organization has used health information technology to improve quality, efficiency, and safety. Key points include:
- Reliant implemented an electronic health record system in 2007 that is now used by all physicians and staff.
- The EHR integrates with other technologies like patient portals, health information exchange, clinical decision support, and analytics tools.
- These technologies help improve care processes like diabetes and hypertension management, follow-up of abnormal test results, and medication management.
- The investments have helped lower Reliant's average annual costs per patient compared to other organizations in Massachusetts.
Actigraphy as a Metric in PAH Research and Clinical CareDuke Heart
Actigraphy devices can provide objective measures of physical activity and are being used more in PAH research and clinical care. Limitations of the 6-minute walk test include only providing a snapshot of function and not capturing daily fluctuations. Activity monitors continuously measure real-world activity levels and have been used in clinical trials to assess changes from baseline as primary or secondary endpoints. Emerging data suggest PAH patients have significantly reduced activity levels compared to controls and activity levels correlate with functional class and quality of life. Activity monitors may help evaluate therapeutic responses more sensitively than the 6-minute walk test alone.
Nursing Documentation (Sports Medicine Hospital) by: Nestor Salazar JrNestor Salazar
I would use Focus Charting to document the patient's nurses notes. There are several reasons why:
- Focus charting centers on the nursing process of assessment, planning, implementation and evaluation. This aligns well with how nurses approach patient care.
- It is flexible and can be adapted to any clinical setting. This allows it to work for different patient populations and care environments.
- Organizing notes by a focus, such as a symptom or behavior, makes the documentation easy to follow and the relevant information easy to find.
- Noting the patient's response to interventions helps evaluate the effectiveness of the care provided. This supports continuous improvement in nursing practice.
- The focus-data-action-response structure
11 Steps of the Nursing Process new 26 11 2018 (2).pptxMosaHasen
Here are some potential clusters from the data:
- Respiratory: difficulty breathing, increased respiratory rate
- Cardiovascular: increased pulse, elevated blood pressure
- Skin/tissue perfusion: lower extremity swelling
- Mobility: difficulty voiding
- Psychosocial: estranged from daughter, dislikes hospitals due to past experience
Some potential nursing diagnoses based on the clusters:
- Impaired gas exchange
- Acute pain
- Risk for deficient fluid volume
- Anxiety
- Readiness for enhanced coping
This document discusses the increasing pressure on healthcare providers to adhere to clinical guidelines and quality metrics. It outlines challenges in implementing clinical decision support systems and electronic medical records to help providers meet these demands. Key points include the need for provider buy-in, reliable guideline-based decision support, and creating a culture where metrics are accepted and do not cause anger or fear.
The nursing process is a systematic, cyclical approach to planning and providing patient care. It consists of five core phases - assessment, diagnosis, planning, implementation, and evaluation. Assessment involves collecting patient data through various methods like interviews, examinations, and record reviews. Diagnosis identifies the patient's actual or potential health problems. Planning develops goals and interventions. Implementation puts the care plan into action. Evaluation assesses the patient's response to interventions and progress toward goals. The nursing process provides structure and organization to nursing care and aims to promote optimal patient outcomes.
The document provides information and guidelines around evaluation and management documentation, including documentation of the chief complaint, history of present illness, review of systems, past medical history, physical exam, and medical decision making. It discusses the components needed for different levels of evaluation and management services and how to tally the level of service based on the history, exam, and medical decision making complexity.
The document discusses analyzing and improving the inpatient discharge process at a hospital. It outlines the current discharge process flow, collects data on discharge times, and identifies inefficiencies and their causes. Suggestions are made to standardize the process, improve communication and reduce non-value adding steps to decrease discharge times. A proposed discharge checklist model is presented to help streamline the process.
Pediatric Adverse Drug Events PresentationJordan Gamart
This document summarizes a webinar on pediatric adverse drug events hosted by the Patient Safety Movement Foundation. The webinar featured presentations from Dr. Anne Lyren on Children's Hospitals' Solutions for Patient Safety and Dr. James Broselow on eBroselow. Dr. Lyren discussed strategies to reduce pediatric adverse drug events through programs, checklists, and technology. Dr. Broselow discussed how assistive technologies can help standardize and simplify drug administration in pediatrics to reduce errors through features like dose verification and guidelines. The webinar provided an overview of initiatives and tools to help hospitals improve pediatric safety.
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Assignment 1 Dealing with Diversity in America from Reconstructi.docxdeanmtaylor1545
Assignment 1: Dealing with Diversity in America from Reconstruction through the 1920s
For History 105: Dr. Stansbury’s classes (6 pages here)
Due Week 3 and worth 120 points. The formal deadline is Monday at 9am Eastern time, Jan. 21. But, due to the King holiday, no late penalty will be imposed if submitted by the end of Jan. 22.
[NOTE ON ECREE: The university is adopting a tool, called ecree for doing writing assignments in many classes. We will be using the ecree program for doing our papers in this class. More instructions on this tool will be posted. You are welcome to type your paper in MS-Word as traditionally done—and then to upload that file to ecree to revise and finish it up. Or, as we suggest, you may type your paper directly into ecree. When using ecree, you should use CHROME as your browser. As posted: “Please note that ecree works best in Firefox and Chrome. Please do not use Internet Explorer or mobile devices when using ecree.”]
BACKGROUND FOR THE PAPER: After the Civil War, the United States had to recover from war, handle western expansion, and grapple with very new economic forms. However, its greatest issues would revolve around the legacies of slavery and increasing diversity in the decades after the Civil War. In the South, former slaves now had freedom and new opportunities but, despite the Reconstruction period, faced old prejudices and rapidly forming new barriers. Immigrants from Europe and Asia came in large numbers but then faced political and social restrictions. Women continued to seek rights. Yet, on the whole, America became increasingly diverse by the 1920s. Consider developments, policies, and laws in that period from 1865 to the 1920s. Examine the statement below and drawing from provided sources, present a paper with specific examples and arguments to demonstrate the validity of your position.
Topic and Thesis Statement—in which you can take a pro or con position:
· Political policies and movements in the period from 1865 to the 1920s generally promoted diversity and “the melting pot” despite the strong prejudices of a few. (or you can take the position that they did not). Use specific examples of policies or movements from different decades to support your position.
After giving general consideration to your readings so far and any general research, select one of the positions above as your position—your thesis. (Sometimes after doing more thorough research, you might choose the reverse position. This happens with critical thinking and inquiry. Your final paper might end up taking a different position than you originally envisioned.) Organize your paper as follows with the four parts below (see TIPS sheet and TEMPLATE also), handling these issues:
1. The position you choose —or something close to it—will be the thesis statement in your opening paragraph. [usually this is one paragraph with thesis statement being the last sentence of the paragraph.]
2. To support your position, use thre.
Assignment 1 Why are the originalraw data not readily us.docxdeanmtaylor1545
Assignment 1
:
Why are the original/raw data not readily usable by analytics tasks? What are the main data preprocessing steps? List and explain their importance in analytics.
Refer to Chapter 3 in the attached textbook:
Sharda, R., Delen, D., Turban, E. (2020). Analytics, Data Science, & Artificial Intelligence: Systems for Decision Support 11E.
ISBN: 978-0-13-519201-6.
Discuss the process that generates the power of AI and discuss the differences between machine learning and deep learning.
Requirement:
****Separate document for each assignment.****
Minimum 300-350 words. Cover sheet, abstract, graphs, and references does not count.
Add references separately for each assignment question.
Double Spaced and APA 7th Edition Format
No plagiarized content please! Attach a plagiarized report.
Check for spelling and grammar mistakes!
$5 max. Please bid if you agree.
Assignment 2
:
What are the privacy issues with data mining? Do you think they are substantiated?
Refer to Chapter 4
in the attached textbook:
Sharda, R., Delen, D., Turban, E. (2020). Analytics, Data Science, & Artificial Intelligence: Systems for Decision Support 11E.
ISBN: 978-0-13-519201-6.
Requirement:
****Separate document for each assignment.****
Minimum 300-350 words. Cover sheet, abstract, graphs, and references does not count.
Add references separately for each assignment question.
Double Spaced and APA 7th Edition Format
No plagiarized content please! Attach a plagiarized report.
Check for spelling and grammar mistakes!
$5 max. Please bid if you agree.
.
Assignment 1 Refer to the attached document and complete the .docxdeanmtaylor1545
Assignment 1
:
Refer to the attached document and complete the following sections from the document (highlighted in yellow):
Policy 1.1
Policy Statement Section Overview
Policy 1.2
Policy Statements Contents
Requirement:
·
****Separate word document for each assignment****
· Minimum 300-350 words. Cover sheets, abstracts, graphs, and references do not count.
·
Add references separately for each assignment question.
·
Strictly follow APA style. Length – 2 to 3 paragraphs.
·
Sources: 2 References to Support your answer
· No plagiarized content please! Attach a plagiarized report.
· Check for spelling and grammar mistakes!
· $5 max. Please bid if you agree.
.
Assignment 1
:
Remote Access Method Evaluation
Learning Objectives and Outcomes
Ø
Explore and assess different remote access solutions.
Assignment Requirements
Discuss which of the two remote access solutions
, virtual private networks (VPNs) or hypertext transport protocol secure (HTTPS),
you will rate as the best.
You need to make a choice between the two remote access solutions based on the following features:
Ø Identification, authentication, and authorization
Ø Cost, scalability, reliability, and interoperability
Requirement:
·
****Separate word document for each assignment****
· Minimum 300-350 words. Cover sheet, abstract, graphs, and references do not count.
·
Add reference separately for each assignment question.
·
Strictly follow APA style. Length – 2 to 3 paragraphs.
·
Sources: 2 References to Support your answer
· No plagiarized content please! Attach a plagiarized report.
· Check for spelling and grammar mistakes!
· $5 max. Please bid if you agree.
Assignment 2
:
Discuss techniques for combining multiple anomaly detection techniques to improve the identification of anomalous objects. Consider both supervised and unsupervised cases.
Requirement:
·
****Separate word document for each assignment****
· Minimum 300-350 words. Cover sheet, abstract, graphs, and references do not count.
·
Add reference separately for each assignment question.
·
Strictly follow APA style. Length – 2 to 3 paragraphs.
·
Sources: 2 References to Support your answer
· No plagiarized content please! Attach a plagiarized report.
· Check for spelling and grammar mistakes!
· $5 max. Please bid if you agree.
Assignment 3
:
Refer to the attached “Term Paper for ITS632(1)” for assignment.
Requirements
:
·
****Separate word document for each assignment****
· Minimum 6 pages. Cover sheet, abstract, graphs, and references do not count.
·
Add reference separately for each assignment question.
·
Strictly follow APA style.
·
Sources: 3-5 References
· No plagiarized content please! Attach a plagiarized report.
· Check for spelling and grammar mistakes!
· $30 max. Please bid if you agree.
.
Assignment 1 Inmates Rights and Special CircumstancesCriteria.docxdeanmtaylor1545
Assignment 1: Inmates Rights and Special Circumstances
Criteria
Unacceptable
Below 60% F
Meets Minimum Expectations
60-69% D
Fair
70-79% C
Proficient
80-89% B
Exemplary
90-100% A
1. Analyze the legal mechanisms in which an inmate can challenge his or her confinement. Support or refute the cost of such challenges to the state and / or federal government. Provide a rationale for your response.
Weight: 30%
Did not submit or incompletely analyzed the legal mechanisms in which an inmate can challenge his or her confinement. Did not submit or incompletely supported or refuted the cost of such challenges to the state and / or federal government. Did not submit or incompletely provided a rationale for your response.
Insufficiently analyzed the legal mechanisms in which an inmate can challenge his or her confinement. Insufficiently supported or refuted the cost of such challenges to the state and / or federal government. Insufficiently provided a rationale for your response.
Partially analyzed the legal mechanisms in which an inmate can challenge his or her confinement. Partially supported or refuted the cost of such challenges to the state and / or federal government. Partially provided a rationale for your response.
Satisfactorily analyzed the legal mechanisms in which an inmate can challenge his or her confinement. Satisfactorily supported or refuted the cost of such challenges to the state and / or federal government. Satisfactorily provided a rationale for your response.
Thoroughly analyzed the legal mechanisms in which an inmate can challenge his or her confinement. Thoroughly supported or refuted the cost of such challenges to the state and / or federal government. Thoroughly provided a rationale for your response.
2. Examine the four (4) management issues that arise as a result of inmates with special needs. Prepare one (1) recommendation for each management issue that effectively neutralizes each concern. Provide a rationale for your response.
Weight: 30%
Did not submit or incompletely examined the four (4) management issues that arise as a result of inmates with special needs. Did not submit or incompletely prepared one (1) recommendation for each management issue that effectively neutralizes each concern. Did not submit or incompletely provided a rationale for your response.
Insufficiently examined the four (4) management issues that arise as a result of inmates with special needs. Insufficiently prepared one (1) recommendation for each management issue that effectively neutralizes each concern. Â Insufficiently provided a rationale for your response.
Partially examined the four (4) management issues that arise as a result of inmates with special needs. Partially prepared one (1) recommendation for each management issue that effectively neutralizes each concern. Partially provided a rationale for your response.
Satisfactorily examined the four (4) management issues that arise as a result of inmates with special needs. Satisfactorily prepare.
Assignment 1 Go back through the business press (Fortune, The Ec.docxdeanmtaylor1545
Assignment 1
Go back through the business press (Fortune, The Economist, BusinessWeek, and so forth and any other LIRN- based articles) and find at least three articles related to either downsizing, implementation of a new technology, or a merger or acquisition. In a minimum of four (4) pages in 7th edition APA formatted paper:
What were the key frontline experiences listed in relation to your chosen change?
How do they relate to those listed in Chapter 4?
Did you identify new ones confronting change managers?
How would you prioritize these experiences?
Do any stand out as “deal breakers”? Why?
What new insights into implementing this type of change emerge from this?
Assignment 2
PA2 requires you to identify a current change in an organization with which you are familiar and evaluate a current public issue about which “something must be done.” In relation to the change issue, think about what sense-making changes might need to be enacted and how you would go about doing this. Assess this in terms of the eight (8) elements of the sense-making framework suggested by Helms Mills and as set out in Table 9.7:
Identity construction
Social sense-making
Extracted cues
Ongoing sense-making
Retrospection
Plausibility
Enactment
Projection
Which ones did you believe you might have the most/least control over and why?
What implications does this have for adopting a sense-making approach to organizational change?
minimum of
four (4) pages document for each assignment
.
Assignment 1 Discussion—Environmental FactorsIn this assignment, .docxdeanmtaylor1545
Assignment 1: Discussion—Environmental Factors
In this assignment, you will have a chance to discuss a topic that brings personality theory together with social psychology. Dealing with unhealthy groups like gangs or cults is an important issue in social psychology. However, you cannot fully address this issue if you do not first understand personality development and how one’s personality affects the choices that are made. Specifically, you will look at Skinner’s behavioral perspective on personality development and discuss how that theory can play a role in this issue of unhealthy groups.
Bob is an adolescent who grew up in a gang-infested part of a large city. His parents provided little supervision while he was growing up and left Bob mostly on his own. He developed friendships with several kids in his neighborhood who were involved in gangs, and eventually joined a gang himself. Now crime and gang activities are a way of life for Bob. These have become his way to identify with his peer group and to support himself.
It is relatively easy to see that Bob’s environment has played a large role in his current lifestyle. This coincides with Skinner’s concept of environment being the sole determinant of how personality develops. Skinner believed that if you change someone’s environment and the reinforcements in that environment, you can change their behavior.
Use the Internet, Argosy University library resources, and your textbook to research Skinner’s concept of the environment and answer the following questions:
If you were to create an environment for Bob to change his behavior from that of a gang member to a respectable and law-abiding citizen, what types of environmental changes and positive reinforcements would you suggest and why?
What are some interventions that are used in the field currently? Are there any evidence-based programs that use these environmental and reinforcement interventions?
Write your initial response in 2–3 paragraphs. Apply APA standards to citation of sources.
By
Saturday, March 1, 2014
, post your response to the appropriate
Discussion Area
. Through
Wednesday, March 5, 2014
, review and comment on at least two peers’ responses.
.
Assignment 1 1. Using a Microsoft Word document, please post one.docxdeanmtaylor1545
Assignment 1
1. Using a Microsoft Word document, please post one federal and one state statute utilizing standard legal notation and a hyperlink to each statute.
2. In the same document, please post one federal and one state case using standard legal notation and a hyperlink to each case.
Assignment 2
A. Social media platforms such as Facebook, Twitter, and even Tiktok have become very powerful and influential. Please give your thoughts on whether governments should regulate the content of content on these media. Minimum 250 words.
B. Respond to two classmates' postings. Minimum 100 words per posting.
.
Assignment 1 Dealing with Diversity in America from Reconstructi.docxdeanmtaylor1545
Assignment 1:
Dealing with Diversity in America from Reconstruction through the 1920s
Due Week 3 and worth 120 points
After the Civil War, the United States had to recover from war, handle western expansion, and grapple with very new economic forms. However, its greatest issues would revolve around the legacies of slavery and increasing diversity in the decades after the Civil War. In the South, former slaves now had freedom and new opportunities but, despite the Reconstruction period, faced old prejudices and rapidly forming new barriers. Immigrants from Europe and Asia came in large numbers but then faced political and social restrictions. Women continued to seek rights. Yet, on the whole, America became increasingly diverse by the 1920s. Consider developments, policies, and laws in that period from 1865 to the 1920s. Examine the statement below and drawing from provided sources, present a paper with specific examples and arguments to demonstrate the validity of your position.
Statement—in which you can take a pro or con position:
Political policies and movements in the period from 1865 to the 1920s generally promoted diversity and “the melting pot” despite the strong prejudices of a few. (or you can take the position that they did not). Use specific examples of policies or movements from different decades to support your position.
After giving general consideration to your readings so far and any general research, select one of the positions above as your position—your thesis. (Sometimes after doing more thorough research, you might choose the reverse position. This happens with critical thinking and inquiry. Your final paper might end up taking a different position than you originally envisioned.) Organize your paper as follows, handling these issues:
The position you choose —or something close to it—will be the thesis statement in your opening paragraph.
To support your position, use three (3) specific examples from different decades between 1865 and 1930. You may narrowly focus on race or gender or immigrant status, or you may use examples relevant to all categories.
Explain why the opposing view is weak in comparison to yours.
Consider your life today: In what way does the history you have shown shape or impact issues in your workplace or desired profession?
Length: The paper should be 500-to-750 words in length.
Research and References: You must use a
MINIMUM of three sources
; the Schultz textbook must be one of them. Your other two sources should be drawn from the list provided below. This is guided research, not open-ended Googling.
Source list for Assignment 1:
Some sources are “primary” sources from the time period being studied. Some sources below can be accessed via direct link or through the primary sources links on Blackboard. Each week has a different list of primary sources. For others, they are accessible through the permalink to the source in our online library: Sources below having
libdatab.
Assignment 1 Due Monday 92319 By using linear and nonlinear .docxdeanmtaylor1545
This document provides guidance for counselors on an upcoming assignment due September 23rd. It instructs counselors to listen both linearly and nonlinearly during client assessments to build a strong therapeutic alliance and identify client needs, resources, strengths and gaps in their stories. Counselors are advised to consider both the conscious and unconscious parts of client stories, including recognizing potential adverse childhood experiences and how that might inform the assessment, guide goal development, and affect client readiness to change.
Assignment 1This assignment is due in Module 8. There are many v.docxdeanmtaylor1545
Assignment 1
This assignment is due in Module 8. There are many variations on WebQuests. Please make sure you follow these instructions and not those listed in the textbook. Although, reading the texts and learning another variation will only benefit you in the future. This assignment is worth 100 points.
1. Find a good website in which you can use for the exercise. If you want your students to learn more about zoo animals, then maybe you should locate your local zoo website and use it as a source. Make sure you choose a site that is age appropriate for your students. And please identify which grade and subject level you have chosen in the title.
2. After deciding on a website, create the student instructions for this exercise. Make sure to incorporate aesthetic value (picture). The instructions are very important because you do want your students to be excited about the activity.
3. You will ask the students 10 questions about the site and its information. Be sure the website is clear in its direction and easily navigated so the students can find the information. Create the questions and type them into a Word document with lines for students to use to fill in their answers.
4. After you finish your WebQuest, make sure you include a sheet with the answers to the questions.
5. Save the document as a .doc, .docx, or pdf and submit it via the assignment drop box by clicking on the title of the assignment.
Submission: To submit, choose the Assignment 4: WebQuest link above and use the file attachment feature to browse for and upload your completed document. Remember to choose Submit to complete the submission.
Grading: This assignment is worth 100 points toward your final grade and will be graded using the Webquest Rubric. Please use it as a guide toward successful completion of this assignment.
Assignment 2
This assignment is due in Module 9. The objective of this lesson is to utilize the Internet to help clarify/expand upon your teaching, while creating a field trip environment for your students.
There are times when you will not have the funding to take your class on an actual field trip. With the help of technology, you can now visit various sites without leaving the room. For assignment 4, you are going to plan a virtual field trip for your classroom. Think about the grade level, subject area, possible topics for the curriculum that you teach, and appropriate online communication. You must create an original, virtual field trip. You cannot use someone else's field trip. Remember, you can utilize various software (PowerPoint, Prezi, etc.) to create this field trip, but be careful, it is not a lesson with technology assisted software. The students have to feel like they are truly at the location of the field trip looking at the exhibit, animal, statue, and so forth. There should be no words on the slides because it is not a classroom lesson, it is a field trip.
You will be the tour guide, and everything you plan to say as the guide shoul.
Assignment 1TextbookInformation Systems for Business and Beyond.docxdeanmtaylor1545
Assignment 1
Textbook:Information Systems for Business and Beyond
Please answer the following
From Chapter 1 – Answer Study questions 1-5 and Exercise 3
From Chapter 2 – Answer Study questions 1-10 and Exercise 2 (should be a Power point presentation)
All the above questions should be submitted in one Word document, except for the PowerPoint presentation (Chapter 2 - Exercise 2).
Please understand that Plagiarism will not be tolerated and will result in a zero grade.
Submission Requirements
Font: Times New Roman, size 12, double-space
Citation Style: APA
References: Please use citations and references where appropriate
No Plagiarism
Chapter 1: What Is an
Information System?
Learning Objectives
Upon successful completion of this chapter, you will be
able to:
• define what an information system is by identifying
its major components;
• describe the basic history of information systems;
and
• describe the basic argument behind the article
“Does IT Matter?” by Nicholas Carr.
Introduction
Welcome to the world of information systems, a world that seems to
change almost daily. Over the past few decades information systems
have progressed to being virtually everywhere, even to the point
where you may not realize its existence in many of your daily
activities. Stop and consider how you interface with various
components in information systems every day through different
Chapter 1: What Is an Information
System? | 9
electronic devices. Smartphones, laptop, and personal computers
connect us constantly to a variety of systems including messaging,
banking, online retailing, and academic resources, just to name a
few examples. Information systems are at the center of virtually
every organization, providing users with almost unlimited
resources.
Have you ever considered why businesses invest in technology?
Some purchase computer hardware and software because everyone
else has computers. Some even invest in the same hardware and
software as their business friends even though different technology
might be more appropriate for them. Finally, some businesses do
sufficient research before deciding what best fits their needs. As
you read through this book be sure to evaluate the contents of each
chapter based on how you might someday apply what you have
learned to strengthen the position of the business you work for, or
maybe even your own business. Wise decisions can result in stability
and growth for your future enterprise.
Information systems surround you almost every day. Wi-fi
networks on your university campus, database search services in
the learning resource center, and printers in computer labs are
good examples. Every time you go shopping you are interacting
with an information system that manages inventory and sales. Even
driving to school or work results in an interaction with the
transportation information system, impacting traffic lights,
cameras, etc. V.
ASSIGNMENT 1TASK FORCE COMMITTEE REPORTISSUE AND SOLUTI.docxdeanmtaylor1545
The document provides instructions for an assignment to analyze an organizational issue and propose solutions as the leader of a task force committee. Students are asked to: 1) Describe the selected organization and issue affecting productivity; 2) Analyze how the current corporate culture contributed to the issue; 3) Identify areas of weakness in the organization; 4) Propose modifications to practices and solutions to resolve the issue; and 5) Prepare a one-page executive summary of recommendations. The assignment aims to expose students to modern organizational challenges and develop solutions reflecting their learning.
Assignment 1Select one of these three philosophers (Rousseau, Lo.docxdeanmtaylor1545
This document contains instructions for 5 separate assignments related to ethics, diversity, and organizational culture. Assignment 1 asks students to analyze differences between ideas of philosophers like Rousseau, Locke and Hobbes and modern democracies. Assignment 2 involves responding to inappropriate workplace comments and discussing ethical and legal implications. Assignment 3 has students analyze alternatives and implications related to a case study on discrimination. Assignment 4 examines organizational culture and inclusion at Sherwood Manufacturing. Assignment 5 is researching diversity at different organizations and comparing their cultures.
Assignment 1Scenario 1You are developing a Windows auditing pl.docxdeanmtaylor1545
Assignment 1
Scenario 1
You are developing a Windows auditing plan and need to determine which log files to capture and review. You are considering log files that record access to sensitive resources. You know that auditing too many events for too many objects can cause computers to run more slowly and consume more disk space to store the audit log file entries.
Answer the following question(s): (2 References)
If computer performance and disk space were not a concern, what is another reason for not tracking audit information for all events?
Scenario 2
Assume you are a security professional. You are determining which of the following backup strategies will provide the best protection against data loss, whether from disk failure or natural disaster:
· Daily full server backups with hourly incremental backups
· Redundant array of independent disks (RAID) with periodic full backups
· Replicated databases and folders on high-availability alternate servers
Answer the following question(s): (2 References)
Which backup strategy would you adopt? Why?
Assignment 1 Submission Requirements
Format: Microsoft Word (or compatible)
Font: Arial, size 12, double-space
Citation Style: APA
Length: At least 350 words for each question
References: At least 2 credible scholarly references for each question
No plagiarism
Assignment 2: Security Audit Procedure Guide
Scenario
Always Fresh wants to ensure its computers comply with a standard security baseline and are regularly scanned for vulnerabilities. You choose to use the Microsoft Security Compliance Toolkit to assess the basic security for all of your Windows computers and use OpenVAS to perform vulnerability scans.
Tasks
Develop a procedure guide to ensure that a computer adheres to a standard security baseline and has no known vulnerabilities.
For each application, fill in details for the following general steps:
1. Acquire and install the application.
2. Scan computers.
3. Review scan results.
4. Identify issues you need to address.
5. Document the steps to address each issue.
Assignment 2 Submission Requirements
Format: Microsoft Word (or compatible)
Font: Arial, size 12, double-space
Citation Style: APA
Length: At least 3 pages
References: At least 4 credible scholarly references
No plagiarism
Assignment 3: System Restoration Procedure Guide
Scenario
One of the security improvements at Always Fresh is setting up a system recovery procedure for each type of computer. These procedures will guide administrators in recovering a failed computer to a condition as near to the point of failure as possible. The goal is to minimize both downtime and data loss.
You have already implemented the following backup strategies for workstation computers:
· All desktop workstations were originally installed from a single image for Always Fresh standard workstations. The base image is updated with all patches and new software installed on live workstations.
· Desktop workstation computers execute a cloud backup eve.
Assignment 1Research by finding an article or case study discus.docxdeanmtaylor1545
A
ssignment 1:
Research by finding an article or case study discussing ONE of the following laws or legal issues as it relates to computer forensics:
1) Electronic Communications Privacy Act (ECPA)
2) Cable Communications Privacy Act (CCOA)
3) Privacy Protection Act (PPA)
4) USA Patriot Act of 2001
5) Search and seizure requirements of the Fourth Amendment
6) Legal right to search the computer media
7) Legal right to remove the computer media from the scene
8) Availability of privileged material on the computer media for examination
Using at least 500 words - summarize the the article you have chosen. You will be graded on Content/Subject Knowledge, Critical Thinking Skills, Organization of Ideas, and Writing Conventions.
.
Assignment 1Positioning Statement and MottoUse the pro.docxdeanmtaylor1545
Assignment 1
Positioning Statement and Motto
Use the provided information, as well as your own research, to assess one (1) of the stated brands (Alfa Romeo Hewlett Packard, Subway, or Sony) by completing the questions below. At the end of the worksheet, be sure to develop a new positioning statement and motto for the brand you selected. Submit the completed template in the Week 4 assignment submission link.
Name:
Professor’s Name:
Course Title:
Date:
Company/Brand Selected (Alfa Romeo Hewlett Packard, Subway, or Sony):
1. Target Customers/Users
Who are the target customers for the company/brand? Make sure you tell why you selected each item that you did. (NOTE: DO NOT say “ANY, ALL, EVERYONE” you cannot target everyone, you must be specific)
Age Bracket: [Insert response]
Gender: [Insert response]
Income Bracket: [Insert response]
Education Level: [Insert response]
Lifestyle: [Insert response]
Psychographics (Interest, Hobbies, Past-times): [Insert response]
Values (What the customer values overall in life): [Insert response]
Other items you would segment up on: [Insert response]
How does the company currently reach its customers/users? What methods and media does the company use to currently reach the customers/users? What methods and media should the company use to currently reach the customers/users?
[Insert response]
What would grab the customers/users’ attention? Why do you think this will capture their attention?
[Insert response]
What do these target customers’ value from the business and its products? Why do you think they value these items?
[Insert response]
2. Competitors
Who are the brand’s competitors? Provide at least 3 competitors and tell why you selected each competitor.
Competitor 1: [Insert response]
Competitor 2: [Insert response]
Competitor 3: [Insert response]
What product category does the brand fit into? Why have you placed this brand into the product category that you did?
[Insert response]
What frame of reference (frame of mind) will customers use in making a choice to use/purchase this brand/service? What other brands/companies might customers compare this brand to (other than the top three identified above)?
[Insert response]
3. USP (Unique Selling Proposition) Creation
What is the brand’s uniqueness? Why do you think this is a key uniqueness for this business?
[Insert response]
What is the competitive advantage of the brand? How is it different from other competing brands? Why do you consider this a competitive advantage?
[Insert response]
What attributes or benefits does the brand have that dominate competitors? Why do you think they dominate?
[Insert response]
How is this brand/company better than its competitors? What is the brand’s USP (Unique Selling Proposition? Why have you decided upon this USP?
Unique Selling Proposition: [Insert response]
Defense of USP: [Insert response]
4. Positioning Statement & Motto
Develop a new positioning statement and motto for the brand you selected. Below is an.
ASSIGNMENT 1Hearing Versus ListeningDescribe how you le.docxdeanmtaylor1545
ASSIGNMENT 1:
Hearing Versus Listening
Describe how you learned how to listen! Please use between 300-500 words to make a complete description of this learned behavior. Did you learn to listen properly? Do you still listen the same way that you were taught as a child? Why or why not?
“Doctor Aunt”
by Eden, Janine and Jim.
CC-BY
.
A mother takes her four-year-old to the pediatrician reporting she’s worried about the girl’s hearing. The doctor runs through a battery of tests, checks in the girl’s ears to be sure everything looks good, and makes notes in the child’s folder. Then, she takes the mother by the arm. They move together to the far end of the room, behind the girl. The doctor whispers in a low voice to the concerned parent: “Everything looks fine. But, she’s been through a lot of tests today. You might want to take her for ice cream after this as a reward.” The daughter jerks her head around, a huge grin on her face, “Oh, please, Mommy! I love ice cream!” The doctor, speaking now at a regular volume, reports, “As I said, I don’t think there’s any problem with her hearing, but she may not always be choosing to listen.”
Hearing
is something most everyone does without even trying. It is a physiological response to sound waves moving through the air at up to 760 miles per hour. First, we receive the sound in our ears. The wave of sound causes our eardrums to vibrate, which engages our brain to begin processing. The sound is then transformed into nerve impulses so that we can perceive the sound in our brains. Our auditory cortex recognizes a sound has been heard and begins to process the sound by matching it to previously encountered sounds in a process known as
auditory association
.
[1]
Hearing has kept our species alive for centuries. When you are asleep but wake in a panic having heard a noise downstairs, an age-old self-preservation response is kicking in. You were asleep. You weren’t listening for the noise—unless perhaps you are a parent of a teenager out past curfew—but you hear it. Hearing is unintentional, whereas
listening
(by contrast) requires you to pay conscious attention. Our bodies hear, but we need to employ intentional effort to actually listen.
“Hearing Mechanics”
by Zina Deretsky. Public domain.
We regularly engage in several different types of listening. When we are tuning our attention to a song we like, or a poetry reading, or actors in a play, or sitcom antics on television, we are listening for pleasure, also known as
appreciative listening
. When we are listening to a friend or family member, building our relationship with another through offering support and showing empathy for her feelings in the situation she is discussing, we are engaged in
relational listening
. Therapists, counselors, and conflict mediators are trained in another level known as
empathetic or therapeutic listening
. When we are at a political event, attending a debate, or enduring a salesperson touting the benefits of vario.
assignment 1
Essay: Nuclear Proliferation
The proliferation of nuclear weapons is closely monitored by the international community. While the international community formally recognizes only five nuclear powers - the United States, Russia, China, France, and the United Kingdom - it is widely acknowledged that at least four others (India, Israel, North Korea, and Pakistan) currently possess nuclear weapons and one other (Iran) is attempting to develop nuclear weapons capabilities.
Describe the current international regime governing the development of nuclear weapons, including the major agreements and treaties controlling nuclear technology. Explain why the international community generally seeks to prevent the proliferation of nuclear weapons. (500-750 words)
assignment 2
World military spending is nearly $2 trillion every year. If you could redirect these funds, how would you use them? Would such uses be better or worse for the states involved? Do you think there is a realistic chance of redirecting military spending in the way you suggest? (150 words minimum)
assignment 3
Human Rights: A Hollow Promise to the World?
( one paragraph )
.
How to Manage Your Lost Opportunities in Odoo 17 CRMCeline George
Odoo 17 CRM allows us to track why we lose sales opportunities with "Lost Reasons." This helps analyze our sales process and identify areas for improvement. Here's how to configure lost reasons in Odoo 17 CRM
LAND USE LAND COVER AND NDVI OF MIRZAPUR DISTRICT, UPRAHUL
This Dissertation explores the particular circumstances of Mirzapur, a region located in the
core of India. Mirzapur, with its varied terrains and abundant biodiversity, offers an optimal
environment for investigating the changes in vegetation cover dynamics. Our study utilizes
advanced technologies such as GIS (Geographic Information Systems) and Remote sensing to
analyze the transformations that have taken place over the course of a decade.
The complex relationship between human activities and the environment has been the focus
of extensive research and worry. As the global community grapples with swift urbanization,
population expansion, and economic progress, the effects on natural ecosystems are becoming
more evident. A crucial element of this impact is the alteration of vegetation cover, which plays a
significant role in maintaining the ecological equilibrium of our planet.Land serves as the foundation for all human activities and provides the necessary materials for
these activities. As the most crucial natural resource, its utilization by humans results in different
'Land uses,' which are determined by both human activities and the physical characteristics of the
land.
The utilization of land is impacted by human needs and environmental factors. In countries
like India, rapid population growth and the emphasis on extensive resource exploitation can lead
to significant land degradation, adversely affecting the region's land cover.
Therefore, human intervention has significantly influenced land use patterns over many
centuries, evolving its structure over time and space. In the present era, these changes have
accelerated due to factors such as agriculture and urbanization. Information regarding land use and
cover is essential for various planning and management tasks related to the Earth's surface,
providing crucial environmental data for scientific, resource management, policy purposes, and
diverse human activities.
Accurate understanding of land use and cover is imperative for the development planning
of any area. Consequently, a wide range of professionals, including earth system scientists, land
and water managers, and urban planners, are interested in obtaining data on land use and cover
changes, conversion trends, and other related patterns. The spatial dimensions of land use and
cover support policymakers and scientists in making well-informed decisions, as alterations in
these patterns indicate shifts in economic and social conditions. Monitoring such changes with the
help of Advanced technologies like Remote Sensing and Geographic Information Systems is
crucial for coordinated efforts across different administrative levels. Advanced technologies like
Remote Sensing and Geographic Information Systems
9
Changes in vegetation cover refer to variations in the distribution, composition, and overall
structure of plant communities across different temporal and spatial scales. These changes can
occur natural.
This presentation was provided by Steph Pollock of The American Psychological Association’s Journals Program, and Damita Snow, of The American Society of Civil Engineers (ASCE), for the initial session of NISO's 2024 Training Series "DEIA in the Scholarly Landscape." Session One: 'Setting Expectations: a DEIA Primer,' was held June 6, 2024.
Leveraging Generative AI to Drive Nonprofit InnovationTechSoup
In this webinar, participants learned how to utilize Generative AI to streamline operations and elevate member engagement. Amazon Web Service experts provided a customer specific use cases and dived into low/no-code tools that are quick and easy to deploy through Amazon Web Service (AWS.)
it describes the bony anatomy including the femoral head , acetabulum, labrum . also discusses the capsule , ligaments . muscle that act on the hip joint and the range of motion are outlined. factors affecting hip joint stability and weight transmission through the joint are summarized.
हिंदी वर्णमाला पीपीटी, hindi alphabet PPT presentation, hindi varnamala PPT, Hindi Varnamala pdf, हिंदी स्वर, हिंदी व्यंजन, sikhiye hindi varnmala, dr. mulla adam ali, hindi language and literature, hindi alphabet with drawing, hindi alphabet pdf, hindi varnamala for childrens, hindi language, hindi varnamala practice for kids, https://www.drmullaadamali.com
This presentation includes basic of PCOS their pathology and treatment and also Ayurveda correlation of PCOS and Ayurvedic line of treatment mentioned in classics.
Film vocab for eal 3 students: Australia the movie
SWP PHARMACEUTICALS, INC. - DATA MANAGEMENT PLANA Prospective,.docx
1. SWP PHARMACEUTICALS, INC. - DATA MANAGEMENT
PLAN
A Prospective, Multicenter, Randomized, Double-Blind, Phase 3
Clinical Study to Compare the Efficacy and Safety of XYZ
Versus Corticosteroid for the Treatment of Lateral Epicondylitis
(LE), Protocol Number ASUCNHI/XYZ-LE/16-17/001
Overview
21 CFR 312.50 spells out the responsibilities of the study
sponsor in the management of clinical trial data and the
verification of study data for completeness and accuracy.
Thorough review of source data is important to ensure adequate
protection of the rights, welfare, and safety of human subjects
and the quality and integrity of the clinical investigation data.
(FDA, 2013). Sponsor review of source data includes meeting
the regulatory requirements for recordkeeping and data
verification by use of the ALCOA principle. ALCOA is the
acronym for the required components of data. These include:
A = Attributable: originator of the data; who entered the data;
audit trail
L = Legible: human readable form, modifications should not
obscure original data; audit trail
C = Contemporaneous: time of data entry should be close to
when procedure performed; audit trail
O = Original: earliest record, modifications should not obscure
original data; audit trail
A = Accurate: correct and complete; valid representation of
source data, corrections documented, quality
processes/measures used; audit trail.
SWP builds it data management plans around the ALCOA
principles with the expectation that chosen study sites comply
2. with ALCOA and the SWP Data Management Plan.
Definitions:
· Data Element - smallest unit of information collected on a
clinical trial subject
· Data Originator – original source of the data; may be
electronic or human; tied to the data element
· eCRF – electronic Case Report Form
· Source Data - original data (electronic or written)
· EDC - Electronic Data Capture System is provided by the
sponsor, data base is created to collected subject data and
follows the eCRF format. Data will be either manually entered
into the EDC or transferred from a paper form and entered by an
individual or automatic transmission from the device into the
eCRF.
· Paper - paper forms used to collect subject data
· Electronic - data electronically transferred to the EDC such as
EKG results, blood pressure monitors
· Data Element Identifiers – data that identifies the originator
including log-in credentials, password, date, time, and subject
tied to data.
· Access - Access to study data is limited to study staff who
record the data, review the data, and enter the data. For the
sponsor, the site monitor generally referred to as a Clinical
Research Associate (CRA), statisticians, data entry and data
management staff.
· Data Review -
· Data must be reviewed by the study site monitor to verify
accuracy and completeness.
· Data reviewed by study coordinator
· Data reviewed by Data entry and data management staff
· Data entered into the EDC must be reviewed and electronically
signed off by site investigator
· Data Modifications & Corrections - to correct data on paper
forms, individual correcting data must use black ink and using
one-line cross through data, add the correct data in the comment
3. box or next to incorrect data, include reason for change, initial
and date the correction. Original data must not be obscured by
corrections on paper forms. EDC systems must include
functions maintain original data and corrected data, data and
time, user, reason for correction/change as required by 21 CFR
11.
· DSMB - Data Safety Monitoring Board. SWP has assigned a
DSMB for this study. All adverse events and serious adverse
events will be submitted to the DSMB for review. Events to be
submitted on a quarterly basis.
· Clinical Research Associate (CRA)/Monitor - Sponsor
representative responsible for monitoring the study site to
verify subject data and compliance with study protocol and
applicable regulations.
· Data Queries - When a monitor notes an inconsistency in data
or incorrect data, the monitor will create a query. The
individual responsible for the data must review the data query
and correct inaccuracies, etc. All queries will be reported and
resolved through the EDC system.
Data Points
The following data in Table 1 must be collected on each study
subject at the following visits:
Table 1: Schedule of events:
No
Evaluations
Screening
Day 0
Visit 1
Day 1
Visit 2 Week 2
Visit 3 Week 4
Visit 4 Week 12
Visit 5 Week 24
1
Informed Consent
5. X
X
6
Urinary Pregnancy Test
For Female Subjects
X
X
X
X
X
7
Ultrasonography
X
8
Randomization
X
9
Study Drug/Control Drug
(Administered under USG guidance)
X
7. X
X
X
X
15
Concomitant Medication
X
X
X
X
X
Table 2 lists the individual data points that need to be collected
for each of the study events. Refer to Table 1 to identify, which
events occur at each visit.
Table 2: Individual Data Points Per Event
Event
Data
Data Point
Informed Consent
Subject ID
Subject Study ID
Date
mm/dd/yyyy
Subject signed & dated
Yes or No
Subject allowed time to review and ask questions
Yes or No
Subject signed prior to initiating study procedures
8. Yes or No
Subject signed & dated HIPAA
Yes or No
Site designee signed & dated
Yes or No / initials / date / time
Demographic Data
Age
Years
Gender
Male or Female
Race
Hispanic or Latino
Not Hispanic or Latino
Ethnic Group
American Indian or Alaska Native
Asian
Black or African American
Native Hawaiian or Other Pacific Islander
White
Dominant Arm
Right or Left
Height
Feet & Inches
Weight
Pounds
Medical History
Diagnosis of LE
9. Yes or No
Date of diagnosis
mm/dd/yyyy
Prior treatments for LE
list
Physical Exam
Exam completed by
MD, NP, RN or PA
Name of examiner
First & Last Name
RS
Notes / Abnormality Yes or No; If Yes explain abnormality and
any follow-up required; date of follow-up; results
CVS
Notes / Abnormality Yes or No; If Yes explain abnormality and
any follow-up required; date of follow-up; results
PA
Notes / Abnormality Yes or No; If Yes explain abnormality and
any follow-up required; date of follow-up; results
CNS
Notes / Abnormality Yes or No; If Yes explain abnormality and
any follow-up required; date of follow-up; results
Ultrasound
Completed
Yes or No
Results
List
Eligible
10. Yes or No / Physician Name
Concomitant Medications
Reviewed with subject
Yes or No
Medication
Generic name
Route
Oral, IM, IV, Other (specify)
Dose
Dose amount
Frequency
OD, BD, TID, QID, Other (specify)
Indication
Disease or condition
Start Date
mm/dd/yyyy
End Date
mm/dd/yy or ongoing
Related to AE
Yes or No, AE# if yes
Adverse Events
Reviewed with subject
Yes or No
Event
Name & describe
11. Start date
mm/dd/yyyy
End Date
mm/dd/yyyy, or ongoing
Severity (determined by PI)
Mild, moderate, severe
Frequency
Single, Intermittent, Continuous
Infusion Related Toxicity
Yes or No
Relationship to IP
Unclassifiable, Unrelated, Unlikely, Possibly, Probably,
Definitely
Action
None,
Medication - started, discontinued,modified,
Hospitalization
Others (specify)
Outcome
Complete Recovery, Recovered w/ sequelae, Ongoing,
Died,
Unknown
Others (specify)
Serious
Yes or No
Reported to the IRB
Yes or No and mm/dd/yyyy
12. Reported to Sponsor
Yes or No and mm/dd/yyyy
Reported to DSMB
Yes or No and mm/dd/yyyy
Serious Adverse Event
Event
Name & describe
Start date
mm/dd/yyyy
End Date
mm/dd/yyyy, or ongoing
Treatment
Describe
Required ER visit
Yes or No; Name of ER, Name of Health Care Provider(s), Date
mm/dd/yyyy
Required hospitalization
Yes or No; Name of Hospital, Name of Health Care Provider(s),
Date mm/dd/yyyy
Related to product
Unclassifiable, Unrelated, Unlikely, Possibly, Probably,
Definitely
Reported to the IRB
Yes or No; date-mm/dd/yyyy
Reported to Sponsor
Yes or No; date-mm/dd/yyyy
13. Reported to DSMB
Yes or No; date-mm/dd/yyyy
Drug Administration
Administered by
Name
Date
mm/dd/yyyy
Drug ID #; Lot #
ID Number; Lot #
Dose
Amount
Anesthesia Used
Yes or No; if yes name of anesthesia and dose
Pregnancy Test
Gender
Male or Female
Performed
Yes or No
If Female & not preformed, reason
Menopause, hysterectomy,
Results
Positive or Negative
Physiotherapy
Conducted
Yes or No
Therapist
Name
14. Exercises
List exercises
Frequency per week/exercise
1x/2x/3x/4x/5x
Duration
# weeks
VAS
Assessor
Name
Score
0 - 100
PRTEE
Assessor
Name
Score at rest
0 - 10
Score with repeated arm movement
0 - 10
Score carrying a plastic bag of groceries
0 - 10
When pain was least
0 - 10
When pain was worst
0 - 10
15. Pain - Turn a doorknob or key
0 - 10
Pain – carry grocery bag or briefcase by handle
0 - 10
Pain - Lift a full cup of coffee or glass of milk
0 - 10
Pain – Open a jar
0 - 10
Pain - Pull up pants
0 - 10
Pain – wring our washcloth or towel
0 - 10
Pain – personal activities (dressing, washing)
0 - 10
Pain - House work (cleaning, maintenance)
0 - 10
Pain – work (job or everyday work)
0 - 10
Pain - Recreational or sport activities
0 - 10
16. ASES - Pain
Assessor
Name
Experience pain in elbow
Yes or No
When at it’s worse
0 - 10
At rest
0 - 10
Lifting heavy object
0 - 10
When doing repeated elbow movements
0 - 10
At night
0 - 10
ASES - Ability to do activities
Assessor
Name
Arm
Right or Left
Button shirt
0 - 3
Manage toileting
0 - 3
Comb hair
17. 0 - 3
Tie shoes
0 - 3
Eat with utensil
0 - 3
Carry a heavy object
0 - 3
Rise from chair pushing with arm
0 - 3
Do heavy household chores
0 - 3
Turn a key
0 - 3
Throw a ball
0 - 3
Do usual work
0 - 3
Do usual sport
0 - 3
ASES - Physician Assessment: Motion
Assessor
Name
Flexion
18. Right score - degree
Left score - degree
Extension
Right score - degree
Left score - degree
Flexion/Extension Arc
Right score - degree
Left score - degree
Pronation
Right score - degree
Left score - degree
Supination
Right score - degree
Left score - degree
Pronation/Supination Arc
Right score - degree
Left score - degree
ASES - Physician Assessment: Stability
Assessor
Name
Testing affected by pain
Right Arm – Yes or No
Left Arm - Yes or No
Flexion
Right Arm - score
Left Arm - score
Extension
Right Arm - score
Left Arm - score
Pronation
Right Arm - score
Left Arm - score
Supination
19. Right Arm - score
Left Arm - score
Grip Strength (kg)
Right Arm - score
Left Arm - score
Data Collection
All study data is to be collected and recorded at the time the
event/procedure occurs, whether electronically or on paper.
Electronic Data
The following data components will be collected electronically
and transferred directly to the electronic data capture (EDC)
system:
· Blood pressure measures
· Randomization
· Ultrasound readings
· VAS data/scores
· ASES data/scores
· PRTEE data/scores
Equipment used to record these data will be connected to the
EDC system through software provided by SWP
Pharmaceuticals. SWP Pharmaceuticals will provide physician
assessor with tablet containing assessments and connected to
the EDC for automatic transmission of assessment scores.
Paper
The remaining data points will be collected on the paper CRF
provided by SWP Pharmaceuticals. Data collected on source
documents, such as urine pregnancy will be transferred from
source to CRF. The site is responsible for maintaining a subject
binder for each subject that includes all CRFs, source
documents, notes to file, informed consent, and other essential
20. documents. Subject binders must be stored in a locked area with
limited access.
Data Validation
The use of a second staff member to enter data provides a
second check of data. The EDC has checks and balances
included in the program to verify data is entered correctly.
Parameters are built around the data points (such as date limits,
age boundaries, proper format of data) to ensure incorrect data
options cannot be entered into the system.
Transfer of Data
Data collected on CRFs should be transferred to the EDC on the
same day as the subject visit, but no later than two (2) business
days after date of subject visit. Data should be entered by a
study staff member different from the staff member who
collected the data. This will provide a second check for
accuracy of data.
Data Access
Only study personnel who have signed a confidentiality
agreement and require access to study data to perform their job
responsibilities are allowed access to study data. Each person
with access must have a verified e-signature on file, and have
been assigned an individual and confidential identification and
password.
IDs and passwords must not be shared with other staff. Only the
assigned individual is to use the password. Passwords must be
changed every 180 days, no password can be used more than
once. Passwords must be 8 – 16 characters and include at least
one uppercase letter, one number and one of the following
special characters & % # - _ ( ). The sponsor should review the
21. site policy to verify that it includes specific instructions to not
share access codes and passwords.
When a staff member is no longer employed, their ID and
password must be removed by the system administrator within
24 hours. When a staff member is terminated their ID and
password must be removed immediately.
Investigator Responsibilities
· The site investigator is responsible for ensuring that study
data is accurate and complete. This is accomplished by
assigning qualified staff to the collect study data and enter data
into the EDC.
· The investigator must review subject CRFs that have been
entered into the EDC, date and sign that they have been
reviewed and are complete.
· Investigator must ensure that data is entered into the EDC
within set time.
Ensure that sites AEs and SAEs are reported to the DSMB on a
quarterly basis by required deadline.
· The investigator is responsible for storing study records for
the time required by the FDA and/or agreed upon in the clinical
trial agreement between the site and the sponsor.
Sponsor Responsibilities
· The sponsor will provide the EDC system and provide training
to appropriate staff.
· The sponsor will provide the study site with CRFs.
· The sponsor will provide tablets with software installed to
transmit electronically captured data to the EDC.
· Sponsor will assign a clinical research associate (CRA) to
monitor the site verifying study data and site compliance with
protocol, GCPs and applicable regulations.
· The sponsor will provide the DSMB report to each study site
22. within 30 days of the DSMB meeting.
Data Safety and Monitoring Board (DSMB)
SWP Pharmaceuticals has assigned a DSMB for this study who
will review adverse and serious adverse events for trends and
possible safety issues. The DSMB will meet on a quarterly basis
to review safety data from all study sites. Each study site must
submit AEs and SAEs to the DSMB fifteen (15) days prior to
the scheduled meeting. The DSMB will submit quarterly review
reports to the sponsor who will submit copies of report to each
study site (within 30 days of the DSMB meeting).
Monitoring
The CRA will monitor the site on a regular basis. Monitoring
will consist of reviewing data via the EDC at a central location
and by visits at the study site. While on site the monitor will
review subject binders to verify data against source documents
and check that the data is complete and accurate. When visiting
study sites the monitor will also review study records and the
conduct of the study for compliance with GCPs, study protocol,
and applicable regulations. (Details of monitoring can be found
in the Sponsor Monitoring Plan - refer Exercise 1.2: Sample
Answer).
When a monitor identifies data that is incorrect or incomplete,
he or she will generate a data query via the EDC and assign it to
the study coordinator or the staff member who was the
originator of the data. The originator of the data is responsible
for reviewing and resolving the query within two (2) business
days of being notified that the query has been generated in the
EDC. Queries are to be resolved via the EDC.
Record Storage & Maintenance
23. All study documents must be stored in a safe and secure
location for a period of two (2) years post approval of the
medical product or two years post termination of the study or
records are to be stored longer by request of sponsor as covered
in the clinical trial agreement (CTA). The site will provide the
sponsor with the name and location of storage facility. At the
end of the required period the site is responsible for destroying
the records in a confidential manner. A note or copy of receipt
of destruction of records will be sent by the site to the Sponsor.
DATA MANAGEMENT PLAN OVERVIEW
A study sponsor should create a Data Management Plan for the
study protocol. This plan should be shared with each of the
study sites. The management plan is created to ensure that data
is collected and managed properly and in compliance with
current applicable regulations and guidelines. Each site can
modify the data management plan to include site specifics, such
as individuals responsible for collecting data, oversight,
equipment used, and policies for access.
The FDA provides guidance documents and regulations (21 CFR
11) related to managing data collected in clinical trials.
Guidance includes the capture, review, and retention of
electronic source data in FDA-regulated clinical investigations.
The guidance is the FDAs effort to ensure the reliability,
quality, integrity, and traceability of data from electronic source
to electronic regulatory submission. (FDA, 2013).
In Guidance for Industry Electronic Source Data in Clinical
Investigations (2013) the FDA provides the following
definitions related to data management:
· An “electronic record as any combination of text, graphics,
data, audio, pictorial, or other information represented in digital
form that is created, modified, maintained, archived, retrieved,
or distributed by a computer system.”
24. · “An eCRF is an example of an electronic record. The eCRF is
an auditable electronic record of information that generally is
reported to the sponsor on each trial subject, according to a
clinical investigation protocol. The eCRF enables clinical
investigation data to be systematically captured, reviewed,
managed, stored, analyzed, and reported.”
· “Source data includes all information in original records and
certified copies of original records of clinical findings,
observations, or other activities in a clinical investigation used
for reconstructing and evaluating the investigation.”
A Data Management Plan should include the following:
· Data Elements - smallest unit of observation collected on a
clinical trial subject. Examples of data elements are weight,
height, race, pain severity, etc.
· Data Originators - each data element is associated with an
originator, which is the source of that data. Originators might
include the study coordinator, the investigator, medical devices
such as EKG, consultants, etc.
· eCRFs - the electronic record where data elements are
captured.
· Source Documents - the original source of the data element,
which can be paper-based or electronic. The source data might
be manually entered into the eCRF (for example a radiology
report) or electronically transmitted by a medical device (blood
pressure monitor).
· Transfer of Source Data Elements into EDC
Paper - manually transferred into the eCRF. The person
transcribing the data from the paper source is considered the
data originator.
Electronic Transmission - automatic transmission from the
device into the eCRF.
· Access - limited access to data by appropriate study staff is
important. Access should only be granted to the investigator,
study coordinator, data entry staff (if applicable), and data
manager (if applicable). Data management must comply with
25. security and privacy measures covered in 21 CFR 11 and
HIPAA. The data management plan should include a list of
individuals with access to the eCRFs. Individuals with access
should have completed appropriate training. Individuals with
access should have their own identification codes and
passwords. Site policy should include specific instructions to
not share access codes and passwords and the consequences of
doing so.
· Data Element Identifiers - this is the information that
identifies the data originator. These identifiers include:date and
time of data entry, originator identification, the subject tied to
the data, any changes made and who made the change, when and
the reason for change.
· Modifications and Corrections – all data must provide a
complete audit trail that allows the reconstruction of the data
from initial entry. Only the investigator or qualified clinical
study staff should perform modifications to the data.
· Data Review
· Investigator - the investigator is responsible for the conduct of
the study and should review and electronically sign-off on
eCRFs.
· Monitor - the sponsor is responsible for verifying the data
collected in the study is accurate and complete. A clinical
research associate (CRA), representative from the sponsor must
monitor the study data on a regular basis.
· DSMB - depending on the risk involved in a study, an
independent data safety monitoring board (DSMB) may be
assigned to review study events to determine that the risk to the
subjects is not too great. This board will look for trends in
adverse and serious adverse events and provide
recommendations on study safety.
· Retention of Records - the investigator is responsible for
ensuring that study records are accurate and complete, storing,
and maintaining the study records for the required time.
References:
26. Food and Drug Administration (FDA). (2013) Guidance for
Industry Electronic
Source Data in Clinical Investigations
FDA. Code of Federal Regulations, Title 21 part 11: Electronic
Records; Electronic Signatures.
Code of Federal Regulations, Title 21 § 50.3: Definitions.
Code of Federal Regulations, Title 21 part 312: Investigational
New Drug
Application.
Code of Federal Regulations, Title 21 part 812: Investigational
Device Exemptions.
Code of Federal Regulations, Title 45 part 170: Health
Information Technology Standards, Implementation
Specifications, and Certification Criteria and Certification
Programs for Health Information Technology.
Food and Drug Administration, guidance for industry on
Computerized Systems Used in Clinical Investigations,
available at:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInfor
mation/Guidances/default.htm.
Food and Drug Administration, ICH guidance for industry E6
Good Clinical Practice: Consolidated Guidance, available at:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInfor
mation/Guidances/default.htm.
27. GOOD CLINICAL TRIALS - DATA MANAGEMENT PLAN
A Prospective, Multicenter, Randomized, Double-Blind, Phase 3
Clinical Study to Compare the Efficacy and Safety of XYZ
Versus Corticosteroid for the Treatment of Lateral Epicondylitis
(LE), Protocol Number ASUCNHI/XYZ-LE/16-17/001
Overview
Data Management Staff Roles and Responsibilities
Data Management Staff Roles and Responsibilities
Staff Role
Responsibilities
·
·
·
·
·
·
Site Policies
Data Access
28. Data Entry & Cleaning
Monitor Visits
Database Closure Checks
Data Archiving Record Storage and Retention
Adverse and Serious Adverse Events Management &
Reconciliation