CCRC EXAM STUDY GUIDE: ACRP CERTIFICATION

The study guide focuses mostly on ICH guidelines which are a part of the recommended study materials for the exam. Because the guidelines are extensive, they present difficulties for exam preparation. For this reason the guidelines have been pared down as much as possible to those portions which are of the most exam relevance. For ICH-GCP (E6) the material has been condensed into a set of bulleted lists for the various topics to permit easier review and memorization. Where regulations are cited these are presented in a greyed box. Comments about various aspects of the regulations are presented in bold italics.Topics other than the ICH guidelines are also included. The problem presented by the exam is that the ICH guidelines are not directed at the regulations as they are applied in the United States. FDA regulations and guidances and where appropriate OHRP guidances are also included as these have been thought to present important material from an educational perspective and may shed light on some of the questions in the exam.The CRC studying for this exam is under pressure. Arduous work schedules make studying for the exam difficult. It is not possible to pay equal attention to all topics of interest. For this reason the topics are marked by degree of importance for the exam with the most important being given a rating of (****) and those of the least importance have been designated with a rating of (*).