| clinical investigator training program: Principles and Practice of Clinical Research John I. Gallin, Frederick P Ognibene, 2011-04-28 The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.*Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government |
| clinical investigator training program: Associate Training Programs in the Medical and Biological Sciences at the National Institutes of Health National Institutes of Health (U.S.), |
| clinical investigator training program: Principles of Good Clinical Practice Michael J. McGraw, 2010 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. |
| clinical investigator training program: Ethical and Regulatory Aspects of Clinical Research Ezekiel J. Emanuel, 2003 Professionals in need of such training and bioethicists will be interested. |
| clinical investigator training program: A Chancellor's Tale Ralph Snyderman, 2016-10-13 During his fifteen years as chancellor, Dr. Ralph Snyderman helped create new paradigms for academic medicine while guiding the Duke University Medical Center through periods of great challenge and transformation. Under his leadership, the medical center became internationally known for its innovations in medicine, including the creation of the Duke University Health System—which became a model for integrated health care delivery—and the development of personalized health care based on a rational and compassionate model of care. In A Chancellor's Tale Snyderman reflects on his role in developing and instituting these changes. Beginning his faculty career at Duke in 1972, Snyderman made major contributions to inflammation research while leading the Division of Rheumatology and Immunology. When he became chancellor in 1989, he learned that Duke’s medical center required bold new capabilities to survive the advent of managed care and HMOs. The need to change spurred creativity, but it also generated strong resistance. Among his many achievements, Snyderman led ambitious institutional growth in research and clinical care, broadened clinical research and collaborations between academics and industry, and spurred the fields of integrative and personalized medicine. Snyderman describes how he immersed himself in all aspects of Duke’s medical enterprise as evidenced by his exercise in following the sheet from the patient's room to the laundry facilities and back, which allowed him to meet staff throughout the hospital. Upon discovering that temperatures in the laundry facilities were over 110 degrees he had air conditioning installed. He also implemented programs to help employees gain needed skills to advance. Snyderman discusses the necessity for strategic planning, fund-raising, and media relations and the relationship between the medical center and Duke University. He concludes with advice for current and future academic medical center administrators. The fascinating story of Snyderman's career shines a bright light on the importance of leadership, organization, planning, and innovation in a medical and academic environment while highlighting the systemic changes in academic medicine and American health care over the last half century. A Chancellor's Tale will be required reading for those interested in academic medicine, health care, administrative and leadership positions, and the history of Duke University. |
| clinical investigator training program: Resources for Clinical Investigation Institute of Medicine (U.S.). Committee for the Study of Resources for Clinical Investigation, 1988 |
| clinical investigator training program: Report of the Director, National Heart, Lung, and Blood Institute National Heart, Lung, and Blood Institute, 1982 |
| clinical investigator training program: Hearings United States. Congress. House, 1964 |
| clinical investigator training program: Research Administration and Management Elliott C. Kulakowski, Lynne U. Chronister, 2006-01-16 This reference text addresses the basic knowledge of research administration and anagement, and includes everything from a review of research administration and the infrastructure that is necessary to support research, to project development and post-project plans. Examples of concepts, case studies, a glossary of terms and acronyms, and references to books, journal articles, monographs, and federal regulations are also included. |
| clinical investigator training program: Envisioning a Transformed Clinical Trials Enterprise in the United States Institute of Medicine, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, 2012-09-13 There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions. With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop. |
| clinical investigator training program: Report of the Director of the National Heart, Lung, and Blood Institute National Heart, Lung, and Blood Institute, |
| clinical investigator training program: National Institutes of Health--oversight United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Health and the Environment, 1975 |
| clinical investigator training program: Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making Institute of Medicine, Roundtable on Research and Development of Drugs, Biologics, and Medical Devices, 1999-07-27 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. |
| clinical investigator training program: Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 National Research Council, Institute of Medicine, Board on Health Sciences Policy, Policy and Global Affairs, Committee on Women in Science and Engineering, Committee on Opportunities to Address Clinical Research Workforce Diversity Needs for 2010, 2006-06-21 Based on a 2003 workshop, this study describes current public and private programs and recommends ways to recruit and retain more women and underrepresented minorities into clinical research, especially physician-scientists and nurses. Federal sponsors should improve data collection, evaluate existing training programs, and increase the diversity of study section review panels. Public and private sponsors should create funding mechanisms with flexible career paths, and universities and professional societies should both play enhanced roles in fostering diversity. A significant push is needed to recruit minorities into nursing and provide more clinical research training for nurse-scientists, nursing students, and nursing faculty. |
| clinical investigator training program: Sharing Clinical Trial Data Institute of Medicine, Board on Health Sciences Policy, Committee on Strategies for Responsible Sharing of Clinical Trial Data, 2015-04-20 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. |
| clinical investigator training program: Clinical Dermatology Trials 101 Adnan Nasir, 2014-11-12 Clinical Dermatology Trials 101 provides dermatologists with a handbook that allows them to become familiar with all aspects of clinical trials. Everything from obtaining the necessary tools and equipment, complying with local, federal, and international guidelines and regulations, and hiring and training staff for the safe and up-to-date conduct of dermatology clinical trials is covered. Written by leading experts in the field, Clinical Dermatology Trials 101 is the only clinical trial how-to available for dermatologists. With skin disease affecting nearly seventy percent of the population over a lifetime, and the rate of development of new drugs and devices for dermatologic use increasing at an exponential rate, there is a tremendous need for training and developing dermatology clinical research facilities to expedite the translation of basic and applied research, from bench to bedside. This is useful for practicing dermatologists, academic dermatologists, dermatology residents, clinical research fellows, dermatology fellows, research scientists, industry dermatologists, and medical students. |
| clinical investigator training program: Clinical Investigations in the 1980s , 1981 |
| clinical investigator training program: Vision Research Program Planning: Introduction, program summary, and recommendations National Advisory Eye Council (U.S.). Vision Research Program Planning Committee, 1975 |
| clinical investigator training program: Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for 2002 United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies, 2001 |
| clinical investigator training program: Arthritis: Work group reports United States. National Commission on Arthritis and Related Musculoskeletal Diseases, 1976 |
| clinical investigator training program: Arthritis : Out of the Maze United States. National Commission on Arthritis and Related Musculoskeletal Diseases, 1976 |
| clinical investigator training program: Report to the Congress of the United States: Work group reports United States. National Commission on Arthritis and Related Musculoskeletal Diseases, 1976 |
| clinical investigator training program: Report to the Congress of the United States, April 1976 United States. National Commission on Arthritis and Related Musculoskeletal Diseases, 1976 |
| clinical investigator training program: Arthritis - Out of the Maze: Work group reports United States. National Commission on Arthritis and Related Musculoskeletal Diseases, 1976 |
| clinical investigator training program: National Institute of Health-oversight, Hearing Before the Subcommittee on Health and the Environment of ..., 94-1, Apr. 21, 1975 United States. Congress. House. Committee on Interstate and Foreign Commerce, 1975 |
| clinical investigator training program: Support Strategies for Clinical Research and Alternative Medicine Research at the NIH United States. Congress. Senate. Committee on Labor and Human Resources. Subcommittee on Public Health and Safety, 1998 |
| clinical investigator training program: Annual Report of the Administrator of Veterans' Affairs for the Fiscal Year Ended June 30 ... (Departmental Ed.) United States. Veterans Administration, 1960 |
| clinical investigator training program: Annual Report United States. Veterans Administration, 1959 |
| clinical investigator training program: Hearings, Reports and Prints of the House Committee on Interstate and Foreign Commerce United States. Congress. House. Committee on Interstate and Foreign Commerce, 1975 |
| clinical investigator training program: Bubble Gum Badge Patrick Stone, 2011-07-22 Contents Chapter 1 The Journey begins Chapter 2 Food work Chapter 3 BIMO Training Chapter 4 BIMO Inspections Chapter 5 International BIMO Inspections Chapter 6 Official-Action-Indicated (OAI) Work Chapter 7 Electronic-Records Review Chapter 8 Regional/District Management Issues Preface A few years ago, I put together a collection of my thoughts regarding the US FDA and my personal experiences over 13 years as a field investigator in Texas. Since then I have had the opportunity to experience a world of new opportunities as a consultant, so I thought it was time to revisit the Bubblegum Badge world. Along with a few colleagues, I have added several new sections and have tightened up some of the language and phrasing. It is, as with everything in life, still a work in progress. As I said in the first edition of this book, I dont intend this book to be either a roasting or a toasting. I hope what it will do is provide a glimpse of what the FDA does well, and what it needs to improve on (as evidenced by audit reports from the Health and Human Services [HHS] Office of Inspector General [OIG]). The name Bubble Gum Badge, by no means suggests a weak or ineffective organization, rather, it is something my friend from the Imports Division stated during a happy hour we were at in 1999. He put it this way: If you think that gold FDA badge is going to get you out of trouble, son, you are wrong! Its a Bubble Gum Badge and is more trouble than you have ever known. Thankfully, I did not get into any real trouble as a young man with a great responsibility to protect and serve. There are many ways to keep harmful products from the US market, and some of which take longer than the proverbial slow boat to China. I was a frontline grunt out in the field, conducting the FDA business of the day. Those twelve years and eight months were some of the most challenging and rewarding moments any one person could ask for. When you sit down to eat today or see your family member take their medications or go into surgery, you can rest assured that at least one of the FDAs finest had at some point in the products life cycle taken a look to see if it passed inspection. FDA does the work that is most taken for granted and expected as a given by the US public. Your tax dollars were always hard at work when I was on the job, even though it may not have always appeared that way. I would like to thank the FDA for taking me around the world and giving me the best training anyone can ask for in this quality assurance (QA) business (on-the-job training). FDA needs your help and more regulatory authority for biologics, drugs, and devices. Only Congress can grant more FDA authority, and budget battles seem to be the mainstay. Most of the information I reference comes from the public domain site www.fda.gov. The FDAs mission is too important not to be modernized, supported, and innovated. FDA falling behind in modernization would mean lives at risk globally. The oversight of our global health market is waiting. If you want it and qualify, your official gold FDA badge is waiting for you. FDA has mine in a vault next to my government international passport (I have my old decommissioned one). Anyone reading this book can be an FDA Consumer-safety officer (CSO)/investigator. Trust me when I say sixty semester hours of accredited college science and some luck on the computer lottery (usaJobs.opm.gov) and youre in. I would suggest higher than a Bachelor of Science education for entry into bioresearch monitoring. As an ex-FDA recruiter and mentor to many new hire FDA field investigators, I would say a graduate degree or higher also assures your entry to drug and device program field work. So, take a look behind the kitchen, Pharmacy, and hospital operation-room doors with me. Thank you, global health providers and professionals (all of you)! Thank you, health-care receivers, all of you; without you, there would be no need for health-care products. I think that includes everyone in the world! Thank you for your time and for coming along to take a microscopic view into one of the most unsung agencies. FDA has very little glitz or glamour and I hope you find something you find interesting in this book. |
| clinical investigator training program: Postdoctoral Research Fellowship Opportunities National Institutes of Health (U.S.), 1995 |
| clinical investigator training program: Medical Research in the Veterans' Administration United States. Veterans Administration, United States. Veterans Administration. Department of Medicine and Surgery, 1962 |
| clinical investigator training program: Clinical Challenges and Complications of IBD Miguel Regueiro, Jason Swoger, 2024-06-01 Physicians treating patients with Inflammatory Bowel Disease (IBD) often face challenges due to the disease itself, associated conditions, and systemic effects. Recently, new medications have been introduced that allow for more aggressive and effective treatment of IBD. With these medications come the risks of adverse side effects, and physicians must vigilantly monitor for any complications. Drs. Miguel D. Regueiro and Jason Swoger have created a unique, user-friendly book that describes how to prevent, recognize, and manage complications encountered in the care of patients with IBD. Clinical Challenges and Complications of IBD aims to provide practical and clinically oriented information to assist physicians with commonly encountered complications of the natural history of IBD, extraintestinal manifestations of IBD, general health and metabolic complications of IBD, and complications arising from both the medical and surgical treatments of IBD. Formatted to allow for quick access of the information, Clinical Challenges and Complications of IBD is organized into sections that allow physicians to both identify potential pitfalls in treatment, as well as focus on health maintenance and specific challenges, including pregnancy, nutrition, and psychological issues. Clinical pearls will be emphasized and each chapter will provide a bulleted summary, along with suggestions for future reading. Clinical Challenges and Complications of IBD is an invaluable guide for gastroenterologists, nurse practitioners, physician assistants, and gastroenterology trainees as it is a one-of-a-kind resource for recognizing and dealing with the challenges and complications in patients with IBD. |
| clinical investigator training program: Vision Research Program Planning National Eye Institute, 1975 |
| clinical investigator training program: General Clinical Research Centers National Institutes of Health (U.S.). Division of Research Resources, 1993 |
| clinical investigator training program: DHEW Publication , 1979 |
| clinical investigator training program: Clinical Applications of Functional Brain MRI Serge A. R. B. Rombouts, Frederik Barkhof, Philip Scheltens, 2007-11-08 Over the past few years FMRI has become one of the most widely used methods for imaging normal brain function, in turn becoming a valuable tool in the study of many psychiatric and neurological disorders. This book provides an overview of the latest FMRI research in a number of these disorders. |
| clinical investigator training program: DHEW Health Research Principles: Documents relating to the development of draft health research principles for the Department of Health, Education, and Welfare; App. C. Public testimony on the draft DHEW health research principles National Institutes of Health (U.S.), 1979 |
| clinical investigator training program: National Institutes of Health United States. Congress. House. Committee on Appropriations, 1964 |
| clinical investigator training program: The Crisis in Clinical Research Edward H. Ahrens, 1992 The current crisis in clinical research cannot be fully appreciated unless the underlying economic, sociological and motivational problems in American medicine are fully understood. Accordingly, this important book describes the evolution of biomedical research in relation to changes in institutional perceptions of the importance of each of the three roles that U.S. medical schools play--teaching, research and service to patients. Ahrens meticulously analyzes seven very different kinds of research activity that are included under the term clinical research. He describes the profound shift in emphasis from patient-oriented research to research at the cellular and molecular level. This shift has created an imbalance between two contrasting research approaches to the problems of human disease--reductionism and integrative research. In searching out the reasons for this change, Ahrens carefully examines institutional supports for clinical research--the medical school environment in which the research is carried out and the main funding source, the National Institutes of Health. This timely work identifies the fundamental differences between reductionism and integrative research and provides clear evidence that if both modes are to prosper in the future, as they must, then patient-oriented research must receive far stronger support from U.S. medical schools and the N.I.H. Ahrens masterfully argues that changes must be made in the special training of clinical investigators and in their funding requirements, and that new working partnerships between clinically skilled M.D.s and technically trained Ph.D.s are urgently needed in order to restore patient-oriented research to full productivity and to accomplish a re-balancing that most effectively assures quality research in the future. |
ClinicalTrials.gov
Study record managers: refer to the Data Element Definitions if submitting registration or results information.
CLINICAL Definition & Meaning - Merriam-Webster
The meaning of CLINICAL is of, relating to, or conducted in or as if in a clinic. How to use clinical in a sentence.
CLINICAL | English meaning - Cambridge Dictionary
CLINICAL definition: 1. used to refer to medical work or teaching that relates to the examination and treatment of ill…. Learn more.
CLINICAL definition and meaning | Collins English Dictionary
Clinical means involving or relating to the direct medical treatment or testing of patients.
Clinical Definition & Meaning | Britannica Dictionary
CLINICAL meaning: 1 : relating to or based on work done with real patients of or relating to the medical treatment that is given to patients in hospitals, clinics, etc.; 2 : requiring treatment as a …
CLINICAL | meaning - Cambridge Learner's Dictionary
CLINICAL definition: 1. relating to medical treatment and tests: 2. only considering facts and not influenced by…. Learn more.
Clinical - definition of clinical by The Free Dictionary
1. pertaining to a clinic. 2. concerned with or based on actual observation and treatment of disease in patients rather than experimentation or theory. 3. dispassionately analytic; …
Clinical - Definition, Meaning & Synonyms | Vocabulary.com
Something that's clinical is based on or connected to the study of patients. Clinical medications have actually been used by real people, not just studied theoretically.
Clinical Definition & Meaning - YourDictionary
Clinical definition: Of, relating to, or connected with a clinic.
Equity Medical | Clinical Research In New York And Kentucky
We pioneer dermatological advancements, collaborating on innovative treatments through research and clinical trials in urban New York City and rural Southern Kentucky.
ClinicalTrials.gov
Study record managers: refer to the Data Element Definitions if submitting registration or results information.
CLINICAL Definition & Meaning - Merriam-Webster
The meaning of CLINICAL is of, relating to, or conducted in or as if in a clinic. How to use clinical in a sentence.
CLINICAL | English meaning - Cambridge Dictionary
CLINICAL definition: 1. used to refer to medical work or teaching that relates to the examination and treatment of ill…. Learn more.
CLINICAL definition and meaning | Collins English Dictionary
Clinical means involving or relating to the direct medical treatment or testing of patients.
Clinical Definition & Meaning | Britannica Dictionary
CLINICAL meaning: 1 : relating to or based on work done with real patients of or relating to the medical treatment that is given to patients in hospitals, clinics, etc.; 2 : requiring treatment as a …
CLINICAL | meaning - Cambridge Learner's Dictionary
CLINICAL definition: 1. relating to medical treatment and tests: 2. only considering facts and not influenced by…. Learn more.
Clinical - definition of clinical by The Free Dictionary
1. pertaining to a clinic. 2. concerned with or based on actual observation and treatment of disease in patients rather than experimentation or theory. 3. dispassionately analytic; …
Clinical - Definition, Meaning & Synonyms | Vocabulary.com
Something that's clinical is based on or connected to the study of patients. Clinical medications have actually been used by real people, not just studied theoretically.
Clinical Definition & Meaning - YourDictionary
Clinical definition: Of, relating to, or connected with a clinic.
Equity Medical | Clinical Research In New York And Kentucky
We pioneer dermatological advancements, collaborating on innovative treatments through research and clinical trials in urban New York City and rural Southern Kentucky.
