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The Duty For Sponor Oversight In Clinical Trials
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Book Synopsis Handbook: The Duty for "Sponsor Oversight" in Clinical Research by : Doris Breiner
Download or read book Handbook: The Duty for "Sponsor Oversight" in Clinical Research written by Doris Breiner and published by BoD – Books on Demand. This book was released on 2022-07-11 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt: The evidence that the sponsor of a clinical trial fulfills the obligation to perform oversight of, e.g. a CRO that carries out outsourced study activities on behalf of the sponsor is not new. Nevertheless, the addendum to the ICH-GCP has explicitly included this as a sponsor responsibility under point 5.2.2. It applies to all sponsors of a clinical trial, independent of the kind of the clinical trial, whether commercial or academic study, if the study activities are outsourced to a CRO. The goal is to ensure the patient safety and data integrity. The review of the sponsor's oversight is also subject to e.g. an inspection by an authority. The first edition of this manual is based on a master's thesis within the framework of the university master's program "Clinical Research". The concept developed is certainly not completely new but is based, inter alia. to already discussed measures or publications, as example, by the English authority MHRA. It is intended to serve as an example to illustrate how the sponsor's duty of supervision can be implemented simply and efficiently in rather small, medium-sized companies. Of course, every company has to decide for itself how to implement it.
Book Synopsis The Duty for Sponor Oversight in Clinical Trials by : Doris Breiner
Download or read book The Duty for Sponor Oversight in Clinical Trials written by Doris Breiner and published by BoD – Books on Demand. This book was released on 2022-12-22 with total page 57 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first edition of the practical guide related to the topic The Duty for Sponsor Oversight in Clinical Research outlined the underlying requirements as well as possible approaches to implement it efficiently in small and mid-sized companies. This was based on a master's thesis released in April 2019. The next edition will focus on the Clinical Data Review which includes all aspects to be considered, for example, the outcome of the overall monitoring oversight activities. Furthermore, to describe and show examples of a standardized score assignment to ensure a unique process of the assessment.
Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Manual for Research Ethics Committees by : Sue Eckstein
Download or read book Manual for Research Ethics Committees written by Sue Eckstein and published by Cambridge University Press. This book was released on 2003-02-20 with total page 584 pages. Available in PDF, EPUB and Kindle. Book excerpt: The sixth edition of the Manual for Research Ethics Committees was first published in 2003, and is a unique compilation of legal and ethical guidance which will prove useful for members of research ethics committees, researchers involved in research with humans, members of the pharmaceutical industry and students of law, medicine, ethics and philosophy.
Book Synopsis A Practical Guide to Managing Clinical Trials by : JoAnn Pfeiffer
Download or read book A Practical Guide to Managing Clinical Trials written by JoAnn Pfeiffer and published by CRC Press. This book was released on 2017-05-18 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.
Book Synopsis Responsible Research by : Institute of Medicine
Download or read book Responsible Research written by Institute of Medicine and published by National Academies Press. This book was released on 2003-02-06 with total page 313 pages. Available in PDF, EPUB and Kindle. Book excerpt: When 18-year-old Jesse Gelsinger died in a gene transfer study at the University of Pennsylvania, the national spotlight focused on the procedures used to ensure research participants' safety and their capacity to safeguard the well-being of those who volunteer for research studies. Responsible Research outlines a three-pronged approach to ensure the protection of every participant through the establishment of effective Human Research Participant Protection Programs (HRPPPs). The approach includes: Improved research review processes, Recognition and integration of research participants' contributions to the system, and Vigilant maintenance of HRPPP performance. Issues addressed in the book include the need for in-depth, complimentary reviews of science, ethics, and conflict of interest reviews; desired qualifications for investigators and reviewers; the process of informed consent; federal and institutional oversight; and the role of accreditation. Recommendations for areas of key interest include suggestions for legislative approaches, compensation for research-related injury, and the refocusing of the mission of institutional review boards. Responsible Research will be important to anyone interested in the issues that are relevant to the practice of using human subjects as research participants, but especially so to policy makers, research administrators, investigators, and research sponsorsâ€"but also including volunteers who may agree to serve as research participants.
Book Synopsis The Role of Purchasers and Payers in the Clinical Research Enterprise by : Institute of Medicine
Download or read book The Role of Purchasers and Payers in the Clinical Research Enterprise written by Institute of Medicine and published by National Academies Press. This book was released on 2002-06-14 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt: In a workshop organized by the Clinical Research roundtable, representatives from purchaser organizations (employers), payer organizations (health plans and insurance companies), and other stakeholder organizations (voluntary health associations, clinical researchers, research organizations, and the technology community) came together to explore: What do purchasers and payers need from the Clinical Research Enterprise? How have current efforts in clinical research met their needs? What are purchasers, payers, and other stakeholders willing to contribute to the enterprise? This book documents these discussions and summarizes what employers and insurers need from and are willing to contribute to clinical research from both a business and a national health care perspective.
Book Synopsis Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making by : Institute of Medicine
Download or read book Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making written by Institute of Medicine and published by National Academies Press. This book was released on 1999-07-27 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.
Book Synopsis Oversight and Review of Clinical Gene Transfer Protocols by : Institute of Medicine
Download or read book Oversight and Review of Clinical Gene Transfer Protocols written by Institute of Medicine and published by National Academies Press. This book was released on 2014-03-27 with total page 78 pages. Available in PDF, EPUB and Kindle. Book excerpt: Gene transfer research is a rapidly advancing field that involves the introduction of a genetic sequence into a human subject for research or diagnostic purposes. Clinical gene transfer trials are subject to regulation by the U.S. Food and Drug Administration (FDA) at the federal level and to oversight by institutional review boards (IRBs) and institutional biosafety committees (IBCs) at the local level before human subjects can be enrolled. In addition, at present all researchers and institutions funded by the National Institutes of Health (NIH) are required by NIH guidelines to submit human gene transfer protocols for advisory review by the NIH Recombinant DNA Advisory Committee (RAC). Some protocols are then selected for individual review and public discussion. Oversight and Review of Clinical Gene Transfer Protocols provides an assessment of the state of existing gene transfer science and the current regulatory and policy context under which research is investigated. This report assesses whether the current oversight of individual gene transfer protocols by the RAC continues to be necessary and offers recommendations concerning the criteria the NIH should employ to determine whether individual protocols should receive public review. The focus of this report is on the standards the RAC and NIH should use in exercising its oversight function. Oversight and Review of Clinical Gene Transfer Protocols will assist not only the RAC, but also research institutions and the general public with respect to utilizing and improving existing oversight processes.
Book Synopsis The Prevention and Treatment of Missing Data in Clinical Trials by : National Research Council
Download or read book The Prevention and Treatment of Missing Data in Clinical Trials written by National Research Council and published by National Academies Press. This book was released on 2010-12-21 with total page 163 pages. Available in PDF, EPUB and Kindle. Book excerpt: Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.
Book Synopsis Principles of Good Clinical Practice by : Michael J. McGraw
Download or read book Principles of Good Clinical Practice written by Michael J. McGraw and published by Pharmaceutical Press. This book was released on 2010 with total page 273 pages. Available in PDF, EPUB and Kindle. Book excerpt: Part of "RPS Pharmacy Business Administration Series", this book offers good clinical practice guidelines. It includes standards on how clinical trials should be conducted, provide assurance of safety and efficacy of various drugs and protect human rights.
Book Synopsis The Fundamentals of Clinical Research by : P. Michael Dubinsky
Download or read book The Fundamentals of Clinical Research written by P. Michael Dubinsky and published by John Wiley & Sons. This book was released on 2022-01-26 with total page 554 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources
Book Synopsis Sponsor & Clinical Investigator Training - Module B / Biologics by : Kalman Dubov
Download or read book Sponsor & Clinical Investigator Training - Module B / Biologics written by Kalman Dubov and published by Kalman Dubov. This book was released on with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical investigations with biologics are commonly complex, requiring detailed knowledge of the regulatory frameworks for both drugs and biologics since the Food & Drug Administration applies the regulations for drugs as well as for biologics for such clinical investigations. The complexity is furthered if the article is a combination biologic-drug or biologic-device. These three modules are designed to assist the sponsor and clinical investigator in conducting professional investigational trials for biologics. The FDA has a specific Center for biologics, with regulations and many guidance documents to assist the industry and investigators in the requirements for such trials. These two modules provide the basics of understanding the regulatory framework and complying with the Agency's requirements. Module A focuses on the Principal Investigator and the responsibilities necessary to comply with FDA requirements during the course of the clinical trial. The module begins with the definition of a biologic, followed by a review of clinical trials, gene transfer studies, the clinical investigator's responsibilities during the trial with regard to documentation, risks, how to respond to the study sponsor, the Data Safety Monitoring Board (DSMB), and the FDA. The module concludes with details regarding the consent form and process, detailing what is necessary to consent a subject into the study. Module B focuses on the study sponsor and the submissions to the FDA for permission to begin the study. The module begins with a review of the protocol sections, together with the electronic Common Technical Document (eCTD), the phases of the clinical investigation, a review of combination products, dual-use technologies, concluding with the FDA audit. These two modules, though comprehensive, can be mastered to the great benefit of the investigational community, and more so, for the patient who will receive an approved biologic that has proven efficacy.
Author :United States. Congress. House. Committee on Government Reform and Oversight Publisher : ISBN 13 : Total Pages :232 pages Book Rating :4.F/5 ( download)
Book Synopsis Clinical Trial Subjects by : United States. Congress. House. Committee on Government Reform and Oversight
Download or read book Clinical Trial Subjects written by United States. Congress. House. Committee on Government Reform and Oversight and published by . This book was released on 1998 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Recruiting Human Subjects by : June Gibbs Brown
Download or read book Recruiting Human Subjects written by June Gibbs Brown and published by DIANE Publishing. This book was released on 2008-08 with total page 25 pages. Available in PDF, EPUB and Kindle. Book excerpt: Evaluates the Dept. of Health and Human Services¿ oversight of sponsor and investigator efforts to recruit human subjects for industry-sponsored clinical trials (CT). It focuses on industry-sponsored CT because in recent years industry sponsors have assumed a more prominent role in the search for new drugs. Sponsors and investigators are facing increasing difficulty finding enough subjects in a timely manner to bring drugs to market within their desired time-frame. This report explains the recruitment practices used in industry-sponsored CT for investigational drugs; identifies major concerns about them; and addresses the extent and type of oversight undertaken by institutional review boards and, the FDA, and the NIH.
Book Synopsis Data Monitoring Committees in Clinical Trials by : Susan S. Ellenberg
Download or read book Data Monitoring Committees in Clinical Trials written by Susan S. Ellenberg and published by John Wiley & Sons. This book was released on 2019-01-15 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: The authoritative guide for Data Monitoring Committees—fully revised and updated The number of clinical trials sponsored by government agencies and pharmaceutical companies has grown in recent years, prompting an increased need for interim monitoring of data on safety and efficacy. Data Monitoring Committees (DMCs) are an essential component of many clinical trials, safeguarding trial participants and protecting the credibility and validity of the study. Data Monitoring Committees in Clinical Trials: A Practical Perspective, 2nd Edition offers practical advice for those managing and conducting clinical trials and serving on Data Monitoring Committees, providing a practical overview of the establishment, purpose, and responsibilities of these committees. Examination of topics such as the composition and independence of DMCs, statistical, philosophical and ethical considerations, and determining when a DMC is needed, presents readers with a comprehensive foundational knowledge of clinical trial oversight. Providing recent examples to illustrate DMC principles, this fully-updated guide reflects current developments and practices in clinical trial oversight and offers expanded coverage of emerging issues and challenges in the field. This new second edition covers the most current information on DMC policies, issues in monitoring trials using new designs, and recent trial publications relevant to DMC decision-making. • Presents practical advice for those managing and conducting clinical trials and serving on Data Monitoring Committees • Illustrates the types of challenging issues Data Monitoring Committees face in practical situations • Provides updated and expanded coverage of topics including regulatory and funding agency guidelines and trial designs and their associated demands and limitations • Includes a new chapter addressing legal issues that affect DMC members and discusses general litigation concerns relevant to clinical research • Expands treatment of current journal publications addressing DMC issues Data Monitoring Committees in Clinical Trials: A Practical Perspective, 2nd Edition is a must-have text for anyone engaged in DMC activities as well as trial sponsors, clinical trial researchers, regulatory and bioethics professionals, and those associated with clinical trials in academic, government and industry settings.
Book Synopsis Sponsor & Clinical Investigator Training - Module A / Biologics by : Kalman Dubov
Download or read book Sponsor & Clinical Investigator Training - Module A / Biologics written by Kalman Dubov and published by Kalman Dubov. This book was released on 2022-01-09 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical investigations with biologics are commonly complex, requiring detailed knowledge of the regulatory frameworks for both drugs and biologics since the Food & Drug Administration applies the regulations for drugs as well as for biologics for such clinical investigations. The complexity is furthered if the article is a combination biologic-drug or biologic-device. These three modules are designed to assist the sponsor and clinical investigator in conducting professional investigational trials for biologics. The FDA has a specific Center for biologics, with regulations and many guidance documents to assist the industry and investigators in the requirements for such trials. These two modules provide the basics of understanding the regulatory framework and complying with the Agency's requirements. Module A focuses on the Principal Investigator and the responsibilities necessary to comply with FDA requirements during the course of the clinical trial. The module begins with the definition of a biologic, followed by a review of clinical trials, gene transfer studies, the clinical investigator's responsibilities during the trial with regard to documentation, risks, how to respond to the study sponsor, the Data Safety Monitoring Board (DSMB), and the FDA. The module concludes with details regarding the consent form and process, detailing what is necessary to consent a subject into the study. Module B focuses on the study sponsor and the submissions to the FDA for permission to begin the study. The module begins with a review of the protocol sections, together with the electronic Common Technical Document (eCTD), the phases of the clinical investigation, a review of combination products, dual-use technologies, concluding with the FDA audit. These two modules, though comprehensive, can be mastered to the great benefit of the investigational community, and more so, for the patient who will receive an approved biologic that has proven efficacy.
