Good Clinical Practice (GCP) Exam Certification

There are SEVERAL BENEFITS to obtaining Good Clinical Practice exam certification and maintaining certification. Major CROs and pharmaceutical/biotech companies now encourage certification. Certification assists the public, healthcare professionals and the industry itself by identifying standards for professional practice and provides confidence that those testing our future medicines do so as trained and competent professionals. Certification is the formal recognition of clinical research professionals who have met professional eligibility requirements and demonstrated at least a minimal level of job-related knowledge and skills. 

  • Exams are conducted twice a year (March & September).
  • The new format exam is ICH only.
  • There are 3 job title categories of certification: CCRA, CCRC and Investigator

Changes to ACRP Certification

Nucleus Network no longer partners with the Association for Clinical Research Professionals (ACRP) to provide GCP certification. However, Nucleus Network strongly recommends this global certification as a benchmark to reflect Australia's top quality researchers.

The major change is that the Certification Exams will be a computer-based test offered through the chosen testing vendor's secure sites. The computer-based testing will also allow instant reads of initial scores, eliminating much of the anxiety of test takers in waiting for their scores. There will also be increased flexibility for test-takers in allowing the test to be taken within a 10-day window rathe rthan only one day in March and September.

The other change not not affect us In Australia - New Zealnd as the testing standard for the exams are now ICH only.

All exam applications will be online. Please consult the ACRP website 

What is Certification?

ACRP's certification is formal recognition of clinical research professionals worldwide who have met the professional eligibility requirements and who have demonstrated a basic level of job-related knowledge and skills. Certification is granted in recognition of documented and verified work experience and after successful performance on a multiple-choice exam.

How were the Certification Exams Developed?


Certification exams were developed with the assistance of a professional testing organization (AMP). The Exam Committees (one for CCRC, one for CRA) identify areas of competency for testing, develop appropriate test questions, and have the exams validated. In 2000 the European CCRI Exam Committee was formed in order to develop and fit an exam to the needs in ICH regions for clinical investigators.

What are the Reliability Measurements used during the exams?

After every certification exam, ACRP's CRA Exam Committee:

1.    Reviews the results with the assistance of AMP, one of the testing industry's leading firms.
2.    Each item is analysed for appropriate psychometric characteristics.
3.    Those items with poor statistical results are reviewed by the Exam Committee to ensure that they have been scored properly.
4.    Participant feedback, both on the exam and with regards to specific items are also reviewed and taken into consideration for future exams.

What are the benefits of Certification?

1. Certification is increasingly recognized by today's global clinical research industry.
2. Major CROs and pharmaceutical companies now encourage CRA certification.
3. Certification assists the public, healthcare professionals and the industry itself by identifying standards for professional practice.

Where can I find out more information about the exam?

Click on the following links below:

 

Back to Top

Exam Preparation

Nucleus Network continues to support exam certification applicants with:

Nucleus Network offers a classroom format which includes a newly updated 50-question mock exam and discussion, group exercises and a review of clinical research topics pertinent to the detailed exam content outline (DCO).

ACRP and APPI are proud of the high quality, relevant and up-to-date review products for those taking the CRA, CRC, and CPI Certification Exams. For Exam Review Packages which are the basis of the Exam Review Course.

Back to Top

Exam Applications

Certification exams, offered in March and September every year, test your expertise on topics and regulations specifically related to your ability to make decisions in specific practical scenarios.

Exam eligibility is determined by academic qualifications and practical work experience. Two years full-time or equivalent part-time clinical research experience performing specific job functions is required to sit for an exam. Please view the Certification Guides for more eligibility details (CRA Guides; CRC Guides; CPI Guides), and the ACRP/APPI Certification Exam Operations Manual for program rules and regulations.

All exams use ICH only as the testing standard

THREE CATEGORIES OF CERTIFICATION EXAM:

Which one should you take?

1. Clinical Physician Investigator (CPI)
A Clinical Trial Investigator, regardless of job title, works at a clinical research site as the investigator whose research activities are conducted under Good Clinical Practices (GCP), local and/or FDA regulations and ICH guidelines.

2. Clinical Research Associate (CRA)
A sponsor or CRO employs the Clinical Research Associate (may include professionals ranging from monitors to project directors). A CRA is independent of the investigative staff conducting the research at the site or institution, and is not generally employed or supervised by the investigative site or institution.

3. Clinical Research Coordinator (CRC)
A Clinical Research Coordinator, Study Site Research Nurse, or Study Site Coordinator,  or Project Manager who works at the clinical site under the immediate direction of the investigator, whose research activities are conducted under Good Clinical Practice regulations.
 
All exam applications will be online. Please consult the ACRP website
Click here to learn more about the exam
 

Back to Top

Re-certification

Academy and APPI certified professionals are required to renew certification every two years from the time of original certification, and must earn Continuing Education Credits to do so. Please see ACRP's Certification Maintenance Guides for detailed information on maintaining your certification.

By maintaining certification, certificants show their willingness to continue the learning process and keep abreast of topical issues affecting the clinical research site. Certification is becoming increasingly recognized as a mark of professional preparation and managers feel it enhances individual professional standing and personal satisfaction, as well as company marketability (for CROs)

For re-certification, completion of 24 contact hours -12 research related - in the last 2 years is required.

Examples of re-certification options to collect points include::

•    become an ACRP trainer
•    attend educational events/webinars
•    complete home-study tests from the MONITOR
•    ClinfoSource online course modules (2hrs each)
•    University course

 

Back to Top