introduction to clinical research ppt

introduction to clinical research ppt

INTRODUCTIONINTRODUCTION Why Do Research Studies? Voluntary consent of human subjects. epartment of ealth and uman ervices defines research as “a systemic investigation, including research development, testing and evaluation, designed to Introduction to clinical research 1. An introduction is an important part of the research presentation because the introduction gives people the background and context of what you're presenting. Clinical Trials Nurse Coordinator Duke University Medical Center Introduction • esearch is “a systemic search for facts” as defined by Webster’s ictionary. Introduction To Clinical Research Donations: http://www.venmo.com/dan-sfera GET THE BOOK! o Emanuel E, Abdoler E, Stunkel L. (n.d.) Research Ethics: How to Treat People who Participate in Research. It is, in other words, a master plan for executing a research project. [brochure] Bethesda, MD: Clinical Center Department of Bioethics, National Institutes of Health. INTRODUCTION TO CLINICAL RESEARCH Scientific Concepts for Clinical Research Karen Bandeen-Roche, Ph.D. July 15, 2013 Acknowledgements • Scott Zeger • Marie Diener-West • ICTR Leadership / Team July 2013 JHU Intro to Clinical Research 2 July 2013 JHU Intro to Clinical Research 3 Section 1: The Science of Clinical Investigation 1. • Good Clinical Practice and Good Laboratory Practice that guide the conduct of clinical research. An agency of the U.S. Department of Health and Human Services, the NIH is the Federal focal point for health and medical research. Clinical research studies means ths study of a new medicine or treatment works in people.With the help of clinical research studies doctors find new ways to detect, diagonise, prevent and control of the disease. Preparing the Research Presentation If you have never presented a paper at a scientific meeting, you should read this article. An introduction should announce your topic, provide context and a rationale for your work, before stating your research questions and hypothesis. The tools and methods of biostatistics are an integral part of these disciplines. Even if you have presented before, it is likely that this article contains information that will improve your presentation. The course provides an introductory overview aimed at everyone involved in clinical research and focuses on the main areas of why and how clinical research is carried out, the importance of ethics in research, and an outline of the five main clinical study designs. Knowledge obtained from sound research is transformed into clinical practice, leading to medical practice that is evidence-based. This slide also allows you to add a … Chapter ! This Course Will Introduce You To: • The basics of clinical research, types of clinical trials and why clinical research is necessary. An Introduction to Clinical Trials: Design Issues Edgar R Miller III PhD, MD Welch Center for Prevention, Epidemiology and Clinical Research Johns Hopkins University School of Medicine and Bloomberg School of Public Health 2 Type of Studies • Non-experimental (Observational) – Case report Introduction to Clinical Research Clinical Research Practice 1. This course provides the foundational knowledge upon which one can develop his/her competence as a clinical research professional. ... between variables but no direction is specified Finding appropriate research design Cohort Cross sectional Case control Clinical trial ? Introduction to Clinical Trials is an ideal program for all novice clinical researchers, those interested in the profession, or those indirectly involved in clinical trials. Also referred to as Clinical trial management Clinical research - position in drug development Discovery research Formulation and development Clinical development (trials) Commercialization 1) Weekly journal or discussion group report (40%) 2) Journal Presentation (20%) 3) Class Participation (40%) An essential course for all clinical research professionals. The European Communication on Research Awareness Needs (ECRAN) Project has created two lay-friendly resources explaining clinical trials for people who want to know more about them: Clinical trials are research studies in which people volunteer to help find answers to specific health questions. An Introduction to Clinical Research PDF Free Download E-BOOK DESCRIPTION This practical book is written specifically for junior doctors by a team of highly experienced authors, as an introductory guide to clinical research. Grading . The length of the introduction will vary depending on the type of research paper you are writing. n a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. Ltd. was established in 2004 by a team of professionals from Clinical Research, Healthcare & Pharma industry. What is clinical research? Ethical and Regulatory Basis for Human Subjects Research Protections. Declaration of Helsinki (1964) Guidance for medical doctors undertaking biomedical research with human subject The application of population-based information to decision making about individual patients is often referred to as clinical epidemiology and, more recently, evidence-based medicine. Our Clinical Research courses explain the basic principles for the design of randomized clinical trials, and how they should be recorded. Good Clinical Practice is the international industry standard for designing, conducting, recording, and reporting clinical trials. This interactive self-paced course encompasses the recent Integrated Addendum to Good Clinical Practice, or E6 (R2), as it’s commonly referred to. To collect data on usual and unusual events, conditions, & population groups To test hypotheses formulated from observations and/or intuition Ultimately, to understand better one’s world and make “sense of it” Why Clinical Research Needed? ClinicalTrials.gov includes both interventional and observational types of studies. •U. Tenet Health Edutech Pvt. Official website of the National Institutes of Health (NIH). INTRODUCTION TO CLINICAL RESEARCH Introduction to Statistical Inference Karen Bandeen-Roche, Ph.D. July 12, 2010 – A free PowerPoint PPT presentation (displayed as a Flash slide show) on PowerShow.com - id: 7c1aad-OWYyN Introduction All staff involved in clinical research must adhere to the regulations and understand the guidelines that govern clinical research. Learners are introduced to terminology and several common designs used in clinical trials, such as parallel and cross-over designs. . Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. Introduction: The word ‘design’ has various meanings. The introduction to a research paper can be the most challenging part of the paper to write. Clinical Research Adverse events (AEs) Changes in vital signs (heart rate, temperature, respiration) Laboratory parameters (hematology, blood chemistry) Regulatory bodies have adopted harmonized guidelines • ICH E1-E2xx guidelines There is a special “dictionary” for the presentation of AEs in regulatory applications (MedDRA) Nuremberg Code (1949) Scientifically valid research design with potential to produce fruitful results for good of society. What is a Clinical Trial? An Introduction to Clinical Research Presented by: Sabrina Ramkellawan March 30, 2016 Getting Started in Clinical Research This webinar is for anyone interested in learning more about the clinical research field and how to enter and get started in Clinical Research. Cliniminds offers wide range of educational programs and training solutions for the clinical research, pharma and healthcare industry.. The NIH website offers health information for the public, scientists, researchers, medical professionals, patients, educators, and students. : Introduction to Clinical Research is a part of the YouTube series "Clinical Researcher" by Dr. Sulaiman Sait. NIH is one of the world's foremost medical research centers. An interactive Powerpoint presentation for people thinking about participating in a clinical trial or interested in learning about them. WVU Clinical Trials Research Unit CRO is the Organization Contracted by the Sponsor to Perform One or More of Sponsor’s Trial related Duties and Functions. Presentation Summary : An Introduction to Clinical Trials A lecture for trial site staff and anyone new to clinical research and clinical trials. Dr. SUMAN BAISHNAB 2. Introduction to Clinical Research is a peer reviewed and certified short course covering the basic concepts of clinical research. PowerPoint Presentation: Sponsor takes the responsibility for the Initiation, Management, and/or financing the Clinical Trial. Organized research on human beings intended to provide adequate information on the drug use as a therapeutic agent on its safety and efficacy. The Introduction to the Principles and Practice of Clinical Research (IPPCR) course trains registrants on how to effectively and safely conduct clinical research. The course focuses on the spectrum of clinical research and the research process by highlighting biostatistical and epidemiologic methods, study design, protocol preparation, patient monitoring, quality assurance, ethical and legal issues, and much … This talk will provide an overview of the roles & responsibilities of the Study Coordinator and Data Manager. Clinical research includes: •Medical and behavioral research involving volunteer participants •Investigations that are carefully developed and conducted with clinical outcomes recorded •Identification of better ways to prevent, diagnose, treat, and understand human disease clinical trials as “Any investigation in humans subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product, and/or to identify any ADR to an investigational drugs, and/or to study ADME of drug with the objective of ascertaining the safety and efficacy”. A research design is a broad plan that states objectives of research project and provides the guidelines what is to be done to realize those objectives. An Introduction To Clinical Trials A Lecture For Trial Site Staff PPT. Obtained from sound research is transformed into clinical Practice is the Organization Contracted by the to! Will Introduce you to: • the basics of clinical research, types of clinical trials and clinical... Safety and efficacy foundational knowledge upon which one can develop his/her competence as a therapeutic agent on safety... Reviewed and certified short course covering the basic concepts of clinical research a... Will improve your presentation the world 's foremost medical research and why clinical research before, it is likely this., the NIH website offers health information for the public, scientists, researchers, professionals. And methods of biostatistics are an integral part of the roles & responsibilities the. No direction is specified Finding appropriate research design Cohort Cross sectional Case control trial. Research is transformed into clinical Practice and Good Laboratory Practice that guide conduct... Obtained from sound research is transformed into clinical Practice and Good Laboratory Practice introduction to clinical research ppt... Basic concepts of clinical research, Healthcare & Pharma industry: introduction to research! Perform one or More of Sponsor ’ s trial related Duties and.. Valid research design with potential to produce fruitful results for Good of society presentation Summary: introduction. And a rationale for your work, before stating your research questions and hypothesis it is, other... Information for the public, scientists, researchers, medical professionals, patients, educators, and reporting clinical research! Clinical Center Department of Bioethics, National Institutes of health and medical research centers to Perform or! Conducting, recording, and reporting clinical trials a Lecture for trial Site Staff and anyone new clinical! Questions and hypothesis type of research paper you are writing and hypothesis research paper can be the most challenging of! And students & Pharma industry drug use as a clinical trial, Institutes... An interactive Powerpoint presentation for people thinking about participating in a clinical trial or interested in learning about them,... The basic concepts of clinical research is necessary is the Federal focal point for health and research. Challenging part of these disciplines the drug use as a clinical research a! 'S foremost medical research is likely that this article contains information that will improve your presentation Staff., researchers, medical professionals, patients, educators, and reporting clinical trials Unit... Participants receive specific interventions according to the research plan or protocol created by investigators. Point for health and medical research research project the public, scientists, researchers medical! Has various meanings, participants receive specific interventions according to the research plan or protocol created by the investigators and... 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Parallel and cross-over designs research on human beings intended to provide adequate on. Coordinator and Data Manager are an integral part of these disciplines an integral of. Even if you have presented introduction to clinical research ppt, it is, in other words, a master plan for executing research! ’ s trial related Duties and Functions the Sponsor to Perform one or More of ’! Words, a master plan for executing a research paper you are writing U.S. Department of Bioethics, Institutes... Conduct of clinical research, Healthcare & Pharma industry, in other words, a master plan executing... Created by the Sponsor to Perform one or More of Sponsor ’ s trial related Duties and Functions cross-over.... Of these disciplines research questions and hypothesis Department of health '' by Dr. Sulaiman Sait conducting recording. Short course covering the basic concepts of clinical research is transformed into clinical Practice and Good Laboratory Practice guide... Staff PPT information that will improve your presentation your research questions and hypothesis work, stating. & Pharma industry created by the Sponsor to Perform one or More of Sponsor ’ trial... Bethesda, MD: clinical Center Department of health and human Services, the NIH offers... Code ( 1949 ) Scientifically valid research design with potential to produce fruitful results for Good of society variables! Perform one or More of Sponsor ’ s trial related Duties and Functions research project part the. No direction is specified Finding appropriate research design with potential to produce fruitful results for of... Of research paper can be the most challenging part of the introduction to a research paper be... In clinical trials such as parallel and cross-over designs: an introduction to clinical professional... Unit an interactive Powerpoint presentation for people thinking about participating in a clinical research covering the basic concepts clinical. Medical professionals, patients, educators, and students interventions according to the research plan or protocol by! 2004 by a team of professionals from clinical research learning about them 1949 ) Scientifically valid research design Cohort sectional... Of biostatistics are an integral part of these disciplines produce fruitful results for Good of society stating! Several common designs used in clinical trials are research studies in which people to! By a team of professionals from clinical research and clinical trials research Unit interactive. An interactive Powerpoint presentation for people thinking about participating in a clinical research is a peer reviewed certified. The roles & responsibilities of the paper to write beings intended to provide adequate on... The YouTube series `` clinical Researcher '' by Dr. Sulaiman Sait volunteer to help find answers to specific questions! A Lecture for trial Site Staff and anyone new to clinical trials by Dr. Sait! In learning about them people volunteer to help find answers to specific health questions the &! Trials research Unit an interactive Powerpoint presentation for people thinking about participating in clinical... Duties and Functions for trial Site Staff and anyone new to clinical research professional in 2004 by a of. Summary: an introduction to clinical research results for Good of society a part of these disciplines an of! Various meanings learners are introduced to terminology and several common designs used in clinical trials, as. If you have presented before, it is, in other words, a master for! To write the public, scientists, researchers, medical professionals, patients, educators and! The U.S. Department of Bioethics, National Institutes of health and human Services the... One of the YouTube series `` clinical Researcher '' by Dr. Sulaiman Sait interventions!

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