No two candidates come to the exam with the same knowledge base. Since experience and educational backgrounds are unique, these differences must be taken into consideration when determining a study method. Begin to prepare using the following steps:
Step 1: Assess your own professional experience. Read carefully through the Detailed Content Outline description for the exam you wish to take. Each exam (CRC, CRA, PI) has a different DCO. Compare the detailed description of knowledge and tasks, plus the proportion of questions, to your own professional experience. Rate your relative skill level and experience on a scale of 0–5 (0 = no experience) as an indicator of how prepared you are for each section and where to invest more of your study focus in preparing for the exam.
While you personally may have limited experience with certain job functions due to your job description with your employer, success on the exam requires you to demonstrate competency in all areas of the exam.
Step 2: Start early and plan ahead. Don’t wait to receive your Eligibility Notice. You must complete and submit your detailed application at least three (3) weeks before the exam. Don’t leave this until the last minute! Focus some learning time on reading in every content category, but spend extra time reading in those categories where your experience is limited. Match your study efforts in relation to the time you have available and the specific study needs you have identified for yourself. Every exam candidate will answer the same number of questions in every category.
Step 3: Schedule your study time. If you decide to set up a study group, you should hold weekly meetings that will take about two hours on one day/evening every week. Schedule flexible blocks of time into your personal schedule. The key is not to memorize what you read, but to understand concepts behind ICH/GCP and best practices in each knowledge category area to supplement your experience. Be sure you understand how your SOPs differ in relation to ICH/GCP.
Step 4: Organize your study notes. It may help you to organize your study notes, articles, summaries, etc. in a binder using either the five (5) exam categories, or your own index. Let your experience guide you in the content areas you are most comfortable with and focus more time in your weaker areas or on those areas with which you are least familiar. Create flashcards to use as study aids.
Step 5: Choose the methods that are right for your study plan. Choose a mentor or colleague who has more experience in the areas in which you are less familiar and ask him/her to review concepts with you. As you perform your daily responsibilities, think about the underlying principles that lead you to take a particular course of action. This will help you connect ICH/GCP to your daily work.
Step 6: Stick to your study group’s plan. Pick a regular night and show up on time. Each of you has the same goal, and everyone has something to offer. Sharing reading and exchanging notes is a great way to lighten the load. Study groups foster friendships and provide an incentive to stay focused on your collective goal. Complete; don’t compete.
Step 7: Don’t panic. Follow the excellent pre-exam advice that the Academy provides, and come to the exam well-rested and prepared.
In addition to reviewing the ICH Guidelines, one way to review is to select texts and training materials you used when first taking on the role of a CRA, CRC or PI. You can select a publication that you may already have on your bookshelf, or one that you can borrow from a colleague. You should select books or publications that cover topics found on the Detailed Content Outline, the ICH Guidelines, or the tenets of GCP, but do not focus on specific (i.e., FDA) regulations.
If you have time, take a workshop or attend a conference session on topics in which you need to become more familiar. Any professional development courses that cover clinical research topics will add to your knowledge base and therefore will help you prepare for the exam.
NOTE: The Academy does not sponsor or endorse any specific educational courses—even if the course is advertised as a “prep” or “review” course for the ACRP Certification Exams. Courses titled this way are at the discretion of the organization offering the course. Those creating the course have not had any inside information about the exam. The same information that is included in this Handbook to help you prepare is publicly available to those creating educational content. Participation in these courses may help you learn or review topics covered on the exam, but you should not expect them to directly cover exam content.