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

By Solar Biomedical

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.

• Language: English
• Publisher: iUniverse
• Release date: Feb 13, 2023
• ISBN: 9781663249920

Solar Biomedical

Solar Biomedical Clinical Research Services is a clinical research specialty company that offers clinical research compliance training and management services to individuals, medical practices, and corporate entities requiring continuing education, certification preparation, and career preparation. Solar Biomedical has over 20 years of clinical research monitoring and training experience that enable it to successfully develop training tools and allow for individuals to learn lengthy guideless and regulations in a fun and innovative capacity.

Book preview

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.

Can I Ever Throw Away Essential Documents?

GCP 4.9.5and 5.5.12

(Find each bolded word in the word search below.)

Essential documents should be retained until at least two years after the last approval of a marketing application in an ICH-region and until there are no pending or contemplated marketing applications in an ICH region or at least two years have elapsed since the formal discontinuation of clinical development of the investigational product. These documents should be retained for a longer period, however, if required by the applicable regulatory requirements or by an agreement with the sponsor. It is the responsibility of the sponsor to inform the investigator/institution as to when these documents no longer need to be retained.

Names of Documents Found in Both the 21 CFRs for Clinical Research and the ICH/GCP Guidelines

(Find each word in the word search below.)

AMENDMENTS

ANNUALREPORT

CASEREPORTFORM

CURRICULUMVITAE

EXPEDITEDREPORT

IRBAPPROVALS

PROGRESSREPORT

PROTOCOLS

SAFETYREPORT

SHIPPINGRECORDS

SOURCEDOCUMENTS