BEGINNER'S VISUAL STUDY GUIDE: CCRP EXAM: SOCRA CERTIFICATION

by Pramod M Lad

Clinical research management, including the management of clinical trials is a complex activity involving several different individuals with varying educational and professional backgrounds. Research investigators, clinical research coordinators, research nurses, monitors, IRB staff, regulatory personnel, to name a few, all play an important role in the clinical trial and clinical research management. . The Society of Clinical Research Associates (SOCRA) provides an important forum for the education, and training of clinical research professionals. A significant component of this training is the certification exam which results in the CCRP (Certified Clinical Research Professional) designation. This designation is particularly important to clinical research coordinators and research nurses who provide the main site-associated support for clinical trial and clinical research management. The certification serves as an important milestone in career development and can assist clinical research coordinators in careers in both academic and teaching hospitals, CROs, as well as within the pharmaceutical industry.Clinical Research Coordinators (CRCs) studying for the CCRP exam related SOCRA certification at our institution have often observed that reading and understanding regulations directly from the Federal Statutes is difficult. The regulations seem to be written by lawyers for lawyers, the language is dense and the structure of the statute with cross-referring sub-clauses, makes comprehension challenging. At our institution we give a series of webinars to CRCs who are studying for CCRP SOCRA certification, which cover the materials in the SOCRA syllabus. Our CRCs have observed that they found the visual material easier to digest than reading the regulations themselves and others have observed that it is a very helpful introduction to the regulations.This book is based in part on these webinars. It covers the essential components of the SOCRA exam, including ICH-GCP, federal regulations outlined in statutes, including Title 45 part 46 (Protection of Human Subjects) , Title 21 part 50 ( Protection of Human Subjects), Title 21 part 56 (Institutional review Boards) Title 21 part 54 (Financial Disclosures by Clinical Investigators) . Also addressed are key FDA statutes involved in the regulation of clinical trials Title 21 part 312 (Investigational New Drug Application), Tile 21 part 812 (Investigational Device Exemptions) and Title 21 part 11(Electronic Records and Electronic Signatures). The CCRP exam covers material based not only on these regulations, but also on guidances issued by OHRP and the FDA and these are addressed as well. It is hoped that the visual study guide will help all coordinators who find reading the statutes difficult. Of course the study guide does not replace reading the statutes but is a fairly comprehensive introduction to them. The author wishes all CRCs success in the CCRP exam and SOCRA certification and hope their career ambitions in clinical research will be realized.

212 pages, Paperback

Published April 3, 2020