The sourcebook for clinical research : a practical guide for study conduct

✍ Scribed by Martien, Natasha; Nelligan, Jeff

• Publisher: Academic Press is an imprint of Elsevier
• Year: 2018
• Tongue: English
• Leaves: 278
• Category: Library

✦ Synopsis

A single trial is complex, with numerous regulations, administrative processes, medical procedures, deadlines and specific protocol instructions to follow. And yet, there has existed no single-volume, comprehensive clinical research reference manual for investigators, medical institutions, and national and international research personnel to keep on the shelf as a ready reference to navigate through trial complexities and ensure compliance with U.S. Federal Regulations and ICH GCP until The Sourcebook for Clinical Research. An actionable, step-by-step guide through beginning to advanced topics in clinical research with forms, templates and checklists to download from a companion website, so that study teams will be compliant and will find all the necessary tools within this book. Additionally, the authors developed Display Posters for Adverse Events Plus Reporting and Medicare Coverage Analysis that can be purchased separately here: https://www.elsevier.com/books-and-journals/book-companion/9780128162422/order-display-posters. Moreover, The Sourcebook for Clinical Research contains clear information and guidance on the newest changes in the industry to keep seasoned investigators and staff current and compliant, in addition to providing detailed information regarding the most complex topics. This book serves as a quick, actionable, off-the-shelf resource to keep by your side at the medical clinic.  Read more...

Abstract: A single trial is complex, with numerous regulations, administrative processes, medical procedures, deadlines and specific protocol instructions to follow. And yet, there has existed no single-volume, comprehensive clinical research reference manual for investigators, medical institutions, and national and international research personnel to keep on the shelf as a ready reference to navigate through trial complexities and ensure compliance with U.S. Federal Regulations and ICH GCP until The Sourcebook for Clinical Research. An actionable, step-by-step guide through beginning to advanced topics in clinical research with forms, templates and checklists to download from a companion website, so that study teams will be compliant and will find all the necessary tools within this book. Additionally, the authors developed Display Posters for Adverse Events Plus Reporting and Medicare Coverage Analysis that can be purchased separately here: https://www.elsevier.com/books-and-journals/book-companion/9780128162422/order-display-posters. Moreover, The Sourcebook for Clinical Research contains clear information and guidance on the newest changes in the industry to keep seasoned investigators and staff current and compliant, in addition to providing detailed information regarding the most complex topics. This book serves as a quick, actionable, off-the-shelf resource to keep by your side at the medical clinic

✦ Table of Contents

Content: The Institutional Review Board and the Clinical Trial b. Data Safety Monitoring Board c. FDA Audits d. Clinical Trials and the Association for the Accreditation of Human Research Protection Programs (AAHRPP) SECTION SIX: CLINICAL TRIAL CONDUCT - A DAILY PERSPECTIVE a. Adverse Events and Reporting in a Clinical Trial b. AE and Reporting Table c. The Code of Federal Regulations and ICH GCP (International College of Harmonization Good Clinical Practice) d. FDA vs HHS regulations e. Blinding and Unblinding in a Clinical Trial f. Translation and Interpretation SECTION SEVEN: AFTER THE TRIAL IS OVER a. Study Closeout b. Document Retention in a Clinical Trial and Retention Timetable c. Publishing the Results of a Clinical Trial d. ICH GCP Essential Documents SECTION EIGHT: EXCEPTIONAL CIRCUMSTANCES IN CLINICAL TRIALS a. Expanded Access Protocol (Compassionate Use) in a Clinical Trial b. Charging for an Investigational New Drug in a Clinical Trial c. Emergency Use of a Test Article in a Clinical Trial d. Research on Decedents and PHI in a Clinical Trial e. Children in Clinical Trials f. Impaired Decision Making Capacity (IDMC) g. Research Subject Advocate, Legally Authorized Representative and Witness SECTION NINE: EDUCATION AND CERTIFICATION IN CLINICAL TRIALS a.Certifications in Clinical Trials - SOCRA, ACRP, MAGI b. Selected College Programs in Clinical Trial Conduct SECTION TEN: NEWEST CHANGES a. SIRB (Smart IRB) b. Clinicaltrials.gov registration and reporting c. ICH GCP E6 R2 d. Common Rule change

✦ Subjects

Clinical trials.;MEDICAL / Pharmacology.;Clinical Trials as Topic.