All About Clinical Research: Word Search and Flash Cards for Ich Guidelines for Good Clinical Practice

Solar Biomedical

Description

A fun and handy tool for clinical research training and preparing for clinical research certification exams.
The purpose of this book is to provide novice and experienced clinical research professionals with a fun and effective way of learning and remembering the information found in ICH guidelines for Good Clinical Practice through word searches and flash cards.
• Use the word search activities to help with word associations to help focus on and learn the different parts of the ICH Guidelines for Good Clinical Practice. The consolidated tripartite harmonized ICH- Good Clinical Practice [E6 (R2) – the Integrated Addendum to E6(R1)], General Considerations for Clinical Trials [E8 (R1)], and Clinical Safety Data Management (E2A), as published in the U.S. Federal Register May 9, 1997 and March 1, 1995 respectively, are attached to this book for your easy reference when solving the word search puzzles.
• Use the flash cards as a tool for remembering specific GCP rules and CFR regulations in clinical research.

Sujets

• Médecine
• Médecine Générale
• Medical
• Activity book
• Rules and Regulations
• Good Clinical Practice
• Study guide
• Clinical trial

Informations

• Publié par: iUniverse
• Date de parution: 13 février 2023
• Nombre de lectures: 0
• EAN13: 9781663249920
• Langue: English

Extrait

ALL ABOUT CLINICAL RESEARCH: WORD SEARCH AND FLASH CARDS FOR ICH GUIDELINES FOR GOOD CLINICAL PRACTICE


(TRAVEL SIZE 2ND EDITION)

A STUDY GUIDE FOR THE INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE (ICH) GUIDELINES FOR GOOD CLINICAL PRACTICE [E6 (R2) – THE INTEGRATED ADDENDUM TO E6(R1)]


SOLAR BIOMEDICAL






ALL ABOUT CLINICAL RESEARCH: WORD SEARCH AND FLASH CARDS FOR ICH GUIDELINES FOR GOOD CLINICAL PRACTICE
(TRAVEL SIZE 2ND EDITION) A STUDY GUIDE FOR THE INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE (ICH) GUIDELINES FOR GOOD CLINICAL PRACTICE [E6 (R2) – THE INTEGRATED ADDENDUM TO E6(R1)]

Copyright © 2023 Solar Biomedical.

All rights reserved. No part of this book may be used or reproduced by any means, graphic, electronic, or mechanical, including photocopying, recording, taping or by any information storage retrieval system without the written permission of the author except in the case of brief quotations embodied in critical articles and reviews.






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ISBN: 978-1-6632-4991-3 (sc)
ISBN: 978-1-6632-4992-0 (e)

Library of Congress Control Number: 2023900865



iUniverse rev. date: 02/07/2023



CONTENTS
Foreword
How To Use This Book

Word Searches
Flash Cards
Word Search Solutions
Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice
ICH Harmonised Guideline: General Considerations for Clinical Studies E8(R1)
ICH Guidelines for Clinical Safety Data Management (E2A)



FOREWORD
Some of the most successful educational practices utilized throughout the United States and United Kingdom are based on accelerated learning techniques (brain games), such as word search and crossword puzzles. When used effectively, these techniques have been reported by learners to make them feel more independent and achieve good results. Teachers have reported evidence of improved institutional ethos and increased learner participation.
Word searches and puzzles are fun, easy, and great exercises for the brain. They require the learner to focus, think, and work toward getting results. It is our hope that this book will serve as a fun and successful study tool for all persons entering the industry as new clinical research professionals, as well as for experienced clinical research professionals preparing to take their certification exams.
Solar Biomedical is dedicated to creating practical and innovative ways of bringing clinical research training to novice and experienced clinical research professionals. The company’s experience in training and monitoring phases I–IV clinical trials affords it over sixteen years of successful outcomes in those areas. The company is backed by clinical research professionals with scientific and advanced degrees in the biological and applied sciences as well as in the educational arts.



HOW TO USE THIS BOOK
It is important to understand that the standards for conducting clinical trials can be divided into two categories: (1) The laws and (2) The rules. Certification exams and daily clinical research practices are based on these two standards. The laws for conducting clinical research trials are enforceable government regulations and are country specific. The laws can be found in a country’s local registries. However, the rules for conducting clinical research trials are guidelines created to facilitate the integrity and acceptance of a clinical trial’s data globally. These rules are found in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines for Good Clinical Practice (GCP), and serve as a uniform global guide for all research professionals to follow. The purpose of this book is to provide clinical research professionals with a fun and effective way of learning and remembering the information found in ICH Guidelines for Good Clinical Practice through word searches and flash cards.
• Use the word search activities to help with word associations to help focus and learn the different parts of the ICH Guidelines for Good Clinical Practice. Guidelines [E6 (R2)] as published at Step 4 of the ICH process in version dated November 9, 2016, [E8 (R1)] as published at Step 4 of the ICH process in version dated October 6, 2021, and Clinical Safety Data Management (E2A) as published in the U.S. Federal Register March 1, 1995 are attached to this book for your easy reference when solving the word search puzzles.
• Use the flash cards as a tool for remembering specific GCP rules in clinical research.



WORD SEARCHES



Safety Is the Name of the Game
(Find each bolded word in the word search below.)
Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety , and well-being of trial subjects are protected; consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible .



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