The Data Safety Monitoring Board Module B

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The Data Safety Monitoring Board Module B

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Author : Kalman Dubov
language : en
Publisher: Kalman Dubov
Release Date :

The Data Safety Monitoring Board Module B written by Kalman Dubov and has been published by Kalman Dubov this book supported file pdf, txt, epub, kindle and other format this book has been release on with Medical categories.

A key function during clinical trials is the Data Safety Monitoring Board (DSMB). The board is composed of several experts who review the investigational trial and receive unblinded data from the clinical investigator as well as the study sponsor. The unblinded data can be reviewed to determine if an adverse event is relevant to the study. The DSMB has the authority, if necessary, to stop the study at an appropriate juncture. There are two modules that present the concept of the DSMB, with specific detail related to investigational studies where the establishment of the DSMB is warranted. The key factor of reviewing an adverse event at an investigational site allows the DSMB to assess the risks in the study. The DSMB is established by charter detailing the scope of the board's authority, the composition of its members, how often the board will meet, and the types of meetings the board will conduct. In addition, the board must be grounded in the design types of studies so they are appreciative of the way the investigational trial will be conducted. Module B continues with different phases of clinical trials, with a key discussion of the study types where a DSMB is mandated. the board must also be aware of the FDA's recall system since it may affect the ongoing investigational trial. The review continues with the types of meetings undertaken by the DSMB, to include information obtained from the Department of Defense Research Monitor who may be a DSMB voting member. The module then reviews the specific actions the DSMB may take during the study, with practical recommendations the board should consider during its meetings. A critical aspect of the board's responsibility is its communication with the institutional review board (IRB (whether a specific IRB or a multiplicity of different IRBs. While the IRB does not receive unblinded data, the DSMB only receives unblinded data, so that communication with the IRB, by necessity, is restricted to data that can be shared with the IRB. However, if the DSMB stops a study, the IRB must be notified immediately so that the study's approval can be withdrawn. The scope of the duties of the DSMB is to provide the members with key data so as to protect the study subjects and ensure the trial is conducted in an optimal manner.

The Data Safety Monitoring Board Module A

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Author : Kalman Dubov
language : en
Publisher: Kalman Dubov
Release Date : 2022-01-09

The Data Safety Monitoring Board Module A written by Kalman Dubov and has been published by Kalman Dubov this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-01-09 with Medical categories.

A key function during clinical trials is the Data Safety Monitoring Board (DSMB). The board is composed of several experts who review the investigational trial and receive unblinded data from the clinical investigator as well as the study sponsor. The unblinded data can be reviewed to determine if an adverse event is relevant to the study. The DSMB has the authority, if necessary, to stop the study at an appropriate juncture. There are two modules that present the concept of the DSMB, with specific detail related to investigational studies where the establishment of the DSMB is warranted. The key factor of reviewing an adverse event at an investigational site allows the DSMB to assess the risks in the study. The DSMB is established by charter detailing the scope of the board's authority, the composition of its members, how often the board will meet, and the types of meetings the board will conduct. In addition, the board must be grounded in the design types of studies so they are appreciative of the way the investigational trial will be conducted. Module B continues with different phases of clinical trials, with a key discussion of the study types where a DSMB is mandated. the board must also be aware of the FDA's recall system since it may affect the ongoing investigational trial. The review continues with the types of meetings undertaken by the DSMB, to include information obtained from the Department of Defense Research Monitor who may be a DSMB voting member. The module then reviews the specific actions the DSMB may take during the study, with practical recommendations the board should consider during its meetings. A critical aspect of the board's responsibility is its communication with the institutional review board (IRB (whether a specific IRB or a multiplicity of different IRBs. While the IRB does not receive unblinded data, the DSMB only receives unblinded data, so that communication with the IRB, by necessity, is restricted to data that can be shared with the IRB. However, if the DSMB stops a study, the IRB must be notified immediately so that the study's approval can be withdrawn. The scope of the duties of the DSMB is to provide the members with key data so as to protect the study subjects and ensure the trial is conducted in an optimal manner.

Consolidated Guidance On Tuberculosis Data Generation And Use Module 4 Surveys Of Costs Faced By Households Affected By Tuberculosis

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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2025-05-23

Consolidated Guidance On Tuberculosis Data Generation And Use Module 4 Surveys Of Costs Faced By Households Affected By Tuberculosis written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-05-23 with Medical categories.

WHO End TB Strategy includes among its top three impact targets that no TB-affected households face total costs that are catastrophic. To measure progress towards the End TB Strategy target, WHO recommends baseline and periodic measurements based on national surveys to assess the total costs incurred by people treated for TB and their households. These surveys have three primary objectives: 1. to document the magnitude and main drivers of different types of costs incurred by people treated for TB and their households in order to guide policies aimed at reducing financial access barriers and minimizing the adverse socioeconomic impact of TB; 2. to determine the baseline, and periodically measure in repeat surveys, the percentage of people treated for TB and their households that incur catastrophic total costs due to TB; 3. to determine use of existing policies to mitigate costs and other socioeconomic impacts faced by people treated for TB and their households, and to recommend refinements of existing policies, or the design of new ones, based on survey results. This updated guidance builds on lessons learned from surveys implemented between 2015-2024. It provides a standardized methodology for conducting health facility-based cross-sectional surveys to assess the direct and indirect costs incurred by people treated for TB and their households. In addition, it provides guidance on conducting dialogue on the survey results and policy implications and in disseminating the survey findings, thereby enabling changes in policy and practice through multisectoral actions.

Who Consolidated Guidelines On Tuberculosis Module 4

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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2022-11-30

Who Consolidated Guidelines On Tuberculosis Module 4 written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-11-30 with Medical categories.

The WHO Consolidated Guidelines on Tuberculosis (TB), Module 4: Treatment - Drug-Resistant Tuberculosis Treatment 2022 update informs health care professionals in Member States on how to improve treatment and care for patients with drug-resistant TB (DR-TB). This document includes two new recommendations - one for the use of a 6-month BPaLM regimen, composed of bedaquiline, pretomanid, linezolid and moxifloxacin in patients with multidrug-resistant or rifampicin resistant TB (MDR/RR-TB) and those with additional resistance to fluoroquinolones (pre-XDR-TB) and another for a 9-month all oral regimen in patients with MDR/RR-TB and in whom resistance to fluoroquinolones has been excluded. In addition, the consolidated guidelines include existing recommendations on treatment regimens for isoniazid-resistant TB, longer all oral regimens, monitoring of treatment response, the timing of antiretroviral therapy (ART) in MDR/RR-TB patients infected with the human immunodeficiency virus (HIV) and the use of surgery for patients receiving MDR-TB treatment. The WHO Consolidated Guidelines on Tuberculosis group all DR-TB recommendations in one document and are complemented by matching modules of the consolidated operational handbook. TB is one of the leading infectious causes of death globally. Drug-resistant TB remains a public health crisis.

Certified Research Administrator Exam Pathway 2025 2026 Version

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Author : Brittany Deaton
language : en
Publisher: Tektime
Release Date : 2025-06-23

Certified Research Administrator Exam Pathway 2025 2026 Version written by Brittany Deaton and has been published by Tektime this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-06-23 with Business & Economics categories.

Ace your CPP exam with confidence Designed with the modern payroll professional in mind, this guide follows the official 2025 & 2026 exam outline and includes easy-to-follow pathways from beginner to expert. What makes this version unique: Clear “Pathway” format — guides you from foundational concepts through advanced scenarios with a structured, progressive learning plan. 500 high-quality practice questions — fully aligned with current CPP domains (federal, state, benefits), each with concise, thorough explanations. Scenario-based learning — real-world examples reflecting multi-state compliance, remote workforce, and evolving regulations. Exam-taking strategies — expert tips on time management, question analysis, and avoiding common pitfalls. Quick-reference appendices — tables for payroll formulas, tax rates, key forms (W‑2, W‑4, 941), and compliance checklists. ✅ Key Features & Benefits 📘 60+ Modular Chapters Covers all major CPP exam topics, organized logically for step-by-step progression. ✍️ 500 Practice Questions with Detailed Explanations Strengthen your retention and test-readiness with ample practice and clarity on every answer. 🔍 Exam Pathway Structure Learn efficiently with a guided curriculum: Core → Intermediate → Mastery. 🧠 Strategy Tools & Study Aids Includes test-taking tips, common pitfalls, cheat sheets, formula cards, and glossary. 🕒 Time-Saving Reference Tools Built-in quick guides for tax deadlines, forms, compliance references—no flipping pages during your prep. 🛠️ Real-World Payroll Scenarios Practical case studies showing the application of theory to daily payroll operations and compliance situations. 🎯 Who It's For Aspiring payroll professionals preparing for the CPP exam in 2025–2026. Experienced payroll staff seeking a refresher or more structured study tool. HR/payroll managers wanting a comprehensive resource for training & team prep. Curriculum developers looking for structured modules and assessment tools. ✔️ Why This Book? Structured learning path Comprehensive 500‑question practice bank Real-world payroll cases + exam strategies Optimized for 2025/26 exam standards Translator: Brittany Deaton PUBLISHER: TEKTIME

Sharing Clinical Trial Data

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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2015-04-20

Sharing Clinical Trial Data written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-04-20 with Medical categories.

Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.

Proceedings Of The 3rd International Conference On Digital Economy And Computer Application Deca 2023

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Author : Charles Chen
language : en
Publisher: Springer Nature
Release Date : 2023-12-01

Proceedings Of The 3rd International Conference On Digital Economy And Computer Application Deca 2023 written by Charles Chen and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-12-01 with Computers categories.

This is an open access book. The 3rd International Conference on Digital Economy and Computer Applications (DECA 2023) will be held on September 22–24, 2023 in Shanghai, China. Digital economy is the main economic form after agricultural economy and industrial economy. It takes data resources as the key element, modern information network as the main carrier, and the integration and application of information and communication technology and all-factor digital transformation as the important driving force to promote a new economic form that is more unified in fairness and efficiency. The essence of digital economy is informationization. Informatization is a social and economic process caused by the revolution of production tools, such as computer and Internet, from industrial economy to information economy. The theme of the conference mainly focuses on digital economy and computer applications and other related research fields, aiming to provide an international cooperation and exchange platform for experts and scholars in related research fields and enterprise development personnel to share research results, discuss existing problems and challenges, and explore cutting-edge technologies. We sincerely invite experts and scholars from universities and research institutions at home and abroad, entrepreneurs and other relevant personnel to contribute and participate in the conference. The DECA 2023 is accepting papers for proceeding publication. We accept contributions from those who care about exploring and enhancing the research and innovation in Digital Economy and Computer Applications in the world. The directions of the call for papers are as follows: Internet of Things (IoT), Blockchain Technology, Service-Oriented and Cloud, Industry Track, Deliver the Intelligent Enterprise, Mobile business and Autonomous Computing and other papers in line with the direction of digital economy and computer applications. We welcome submissions from scholars, students, and practitioners across many disciplines that contribute to the study and practice of Digital Economy and Computer Applications.

Data Monitoring Committees In Clinical Trials

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Author : Susan S. Ellenberg
language : en
Publisher: Wiley
Release Date : 2002-08-30

Data Monitoring Committees In Clinical Trials written by Susan S. Ellenberg and has been published by Wiley this book supported file pdf, txt, epub, kindle and other format this book has been release on 2002-08-30 with Mathematics categories.

There has been substantial growth in the use of data monitoring committees in recent years, by both government agencies and the pharmaceutical industry. This growth has been brought about by increasing recognition of the value of such committees in safeguarding trial participants as well as protecting trial integrity and the validity of conclusions. This very timely book describes the operation of data monitoring committees, and provides an authoritative guide to their establishment, purpose and responsibilities. * Provides a practical overview of data monitoring in clinical trials. * Describes the purpose, responsibilities and operation of data monitoring committees. * Provides directly applicable advice for those managing and conducting clinical trials, and those serving on data monitoring committees. * Gives insight into clinical data monitoring to those sitting on regulatory and ethical committees. * Discusses issues pertinent to those working in clinical trials in both the US and Europe. The practical guidance provided by this book will be of use to professionals working in and/or managing clinical trials, in academic, government and industry settings, particularly medical statisticians, clinicians, trial co-ordinators, and those working in regulatory affairs and bioethics.

Protecting Human Research Subjects At The Department Of Energy

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Author : United States. Department of Energy. Office of Health and Environmental Research
language : en
Publisher:
Release Date : 1992

Protecting Human Research Subjects At The Department Of Energy written by United States. Department of Energy. Office of Health and Environmental Research and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1992 with Body, Human categories.

Automotive Engine Performance

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Author : Nicholas Goodnight
language : en
Publisher: Jones & Bartlett Learning
Release Date : 2019-02-20

Automotive Engine Performance written by Nicholas Goodnight and has been published by Jones & Bartlett Learning this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-02-20 with Transportation categories.

Automotive Engine Performance, published as part of the CDX Master Automotive Technician Series, provides technicians in training with a detailed overview of modern engine technologies and diagnostic strategies. Taking a “strategy-based diagnostic” approach, it helps students master the skills needed to diagnose and resolve customer concerns correctly on the first attempt. Students will gain an understanding of current diagnostic tools and advanced performance systems as they prepare to service the engines of tomorrow.