Documentos de Académico
Documentos de Profesional
Documentos de Cultura
ACRP
General knowledge of:
Laboratory terminology, tests, and procedures
Basic math, including adding, subtracting,
multiplying, dividing, and calculating
percentages
Proficiency in the areas of:
Investigational Product Management
Protocol
Safety
Trial Management
Trial Oversight
See Detailed Content Outline (DCO)
ICH GCP Guidelines E6, E2A, E8, E9
Declaration of Helsinki
http://www.socra.org/certification/ccrp-certification-exam/exam-outline
http://www.acrpnet.org/PDF/CRC_Handbook.pdf
11
54
312
812
E2A
E8
E9
Duration: 4 hrs
135 multiple choice and true/false questions
Test questions are designed to be straightforward
and easily understood.
Case studies that relate to clinical research
practice
Current cut score is 80% and requires that the
candidate correctly completes 108 out of the 135
examination questions.
Member of SoCRA
1.
Working with Good Clinical Practice (GCP) guidelines under IRB approved protocols
2.
http://www.socra.org/certification/ccrp-certification-exam/candidate-eligibility
Duration: 3 hrs
125 multiple choice questions
Practice based exam with hypothetical scenarios,
no trick questions
Approximately 74% of candidates are successful
on their first exam attempt.
Scaled score of 600 (800 max.) required to pass
indicates that, while a different number of correct
answers may be required from one administration
to the next, the passing point for all examinations
represents the same level of knowledge.
http://www.acrpnet.org/PDF/CRC_Handbook.pdf
Preparation Tools
1.
2.
3.
4.
5.
(http://www.acrpnet.org/prepareforyourexam)
Exam Practice Exercise
ACRP's new Certification Exam Preparation eLearning Course
Exam Prep Packages
Preparation Tools
Pharmaschool (free): http://www.pharmaschool.co/resources.asp.
Under the general resources there is a jargonbuster with key
definitions
GCP and Clinical Research Tests there are various multiple choice
quizzes
Registered Users can go to My GCP Zone to score your quizzes
and tell you how you compare to the average user.
*The website is based out of the UK there are some specific questions
regarding EU regulations, but overall was found to be extremely
helpful.
15
Preparation Ideas
STEP 1: Assess your own professional experience
STEP 2: Start early and plan ahead.
STEP 3: Schedule your study time. 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 in
answering questions on the exam.
STEP 4: Assemble your study notes in a binder.
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.
STEP 6: Stick to your study groups plan.
STEP 7: Dont panic! Follow the excellent pre-exam advice that the
Academy provides, and come to the exam well-rested and prepared.
http://www.acrpnet.org/PDF/CRC_Handbook.pdf
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Pre-Exam Assessment
Test current knowledge by completing the
questionnaires
Final Tips
Certification Prep from Coordinators:
When you apply to take the certification exam: be prepared to literally justify why and how
you meet all of the qualification requirements
detail your experience and make sure it adds up to the specific requirements indicated.
They will reject your application if you do not show how you meet eligibility.
Concentrate on the big picture: ICH guidelines E6, E8, Declaration of Helsinki.
Make sure you understand the difference between your local guidelines/requirements and
the international/ federal regulations for clinical research
Noticed emphasis on phases of clinical drug development and statistical principles for
clinical trials
Take the practice exam: dissect each question as there's some truth or reason to all the
answers listed.
Be able to critically asses various situations that could happen in research - especially those
you are not familiar with because you will most likely come across that and slow you down
during the exam
Be prepared for math/calculation questions for drug accountability/subject compliance, etc.
Understand the process of the testing center and taking a test on a computer
Special Thanks
Contributors
Division/Department/Facility