Clinical Research Certification - CCRA, CCRC, CPI
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Gaining a clinical research certification can offer many benefits for those in the field. Earning a credential through a rigorous application review and test indicates to potential employers that the holder boasts specific experience and skills making him or her more likely to succeed in a given occupation.
In the case of clinical research, this is especially important since running clinical trials requires hands-on training and continued guidance to ensure compliance with long-established standards.
These clinical research professionals include varied roles, including clinical research associates (CRA), clinical research coordinators (CRC), and principal investigators (PI).
In sum, having a certification in one of these areas can provide the following advantages:
Enhances Professionalism – Certified clinical researchers and investigators can take their career to a more professional level by:
- Becoming well-grounded in a core body of knowledge defined by the certifying body
- Committing to the pursuit of knowledge in their area of expertise through ongoing professional development
- Gaining certification through assessment signifying they possess the knowledge and skills necessary to lead in their field
- Committing to follow a code of ethics as defined by the certifying body
Indicates Competence – Through certification, an applicant’s knowledge and skills as a qualified, ethical clinical researcher are validated by a third party. Certification verifies an understanding of international clinical research standards and the ability to apply those standards to the researcher’s profession.
Applies Quality Standards to the Profession – Certified clinical researchers commit to the protection of human subjects, compliance with research regulations, and the quality of the data they collect.
Sets a Professional Apart from Others – Researchers who gain certification show their commitment to quality, ethics, and international research standards which sets them apart from those without certification. Clinical research certifications prepare researchers for career advancement and greater responsibility as leaders in their field.
Can increase Salary – Certified clinical researchers also have the potential to earn more than their non-certified colleagues.
Become a Certified Clinical Research Associate (CCRA)
Certifying Agency: The Association of Clinical Research Professionals (ACRP)
Eligibility Requirements: Applicants must attest to having at least 3,000 hours of work experience performing the tasks and knowledge of the content areas of the CCRA exam. Experience older than ten years will not be considered. See below for exam content details.
Up to 1,500 hours of work experience may be substituted for one of the following options:
- Current ACRP-CP, CCRC, CCRA, and CPI Designation OR
- Graduate from a clinical research education program accredited by the Council on Higher Education Accreditation (CHEA)
All applicants undergo a formal eligibility review process upon application.
Exam Details: The exam assesses proficiency in six core knowledge areas including:
| Content Areas | Percentage of Items on Exam |
|---|---|
| Scientific Concepts and Research Design | 8% |
| Ethical and Participant Safety Considerations | 20% |
| Product Development and Regulation | 10% |
| Clinical Trial Operations (GCPs) | 25% |
| Study and Site Management | 25% |
| Data Management and Informatics | 12% |
Candidates must show they can apply that knowledge to their professional responsibilities. Applicants can download a Detailed Content Outline (DCO) and a CCRA Exam Handbook from the CRA Certification page under “About the Exam”.
- Exam Format: 125 multiple-choice questions that test knowledge based on memory, application, and analysis of information
- Exam Duration: Maximum of three hours
- Exam Delivery: Secure computer terminals
- Exam Language: English
- Exam Fees: Total exam fees range from $435 to $600 depending on ACRP membership status and when applicants apply for the exam (early-bird or regular). This includes an application fee and an exam fee. Note that all non-members will receive one year of ACRP membership upon passing the exam.
- Exam Dates: Spring 2024 Exam Dates: February 15 to May 15, 2024; Fall 2024 Exam Dates: July 15 to October 15, 2024
Renewal Process: According to the Maintenance of Certification Program through ACRP, certified individuals must participate in 24 contact hours or points of continuing education and activities every two years. Alternatively, they may retake the certification exam.
Careers for CRAs: Clinical research associates are employed by sponsors from pharmaceutical companies, device companies, grant companies, universities, sponsoring physicians, or other entities. They serve in the role of an independent monitor in the administration and progression of clinical trials on behalf of the sponsor. CRA certification can advance a career as a:
- Clinical Research Associate
- LPN
- RN
- LVN
- Research Nurse
- Independent Consultant/Contractor
Become a Certified Clinical Research Coordinator (CCRC)
Certifying Agency: The Association of Clinical Research Professionals (ACRP)
Eligibility Requirements: Applicants must attest to having at least 3,000 hours of work experience performing the tasks and knowledge of the content areas of the CCRC exam. Experience older than ten years will not be considered. See below for exam content details.
Up to 1,500 hours of work experience may be substituted for one of the following options:
- Current ACRP-CP, CCRC, CCRA, and CPI Designation OR
- Graduate from a clinical research education program accredited by the Council on Higher Education Accreditation (CHEA)
All applicants undergo a formal eligibility review process upon application.
Exam Details: The exam assesses proficiency in six core knowledge areas including:
| Content Areas | Percentage of Items on Exam |
|---|---|
| Scientific Concepts and Research Design | 8% |
| Ethical and Participant Safety Consideration | 20% |
| Product Development and Regulation | 14% |
| Clinical Trial Operations (GCPs) | 23% |
| Study and Site Management | 22% |
| Data Management and Informatics | 13% |
Examinees must show they can apply that knowledge to their professional responsibilities. Applicants can download a Detailed Content Outline (DCO) and a CCRC Exam Handbook from the CRC Certification page under “About the Exam”.
- Exam Format: 125 multiple-choice questions that test knowledge based on memory, application, and analysis of information
- Exam Duration: Maximum of three hours
- Exam Delivery: Secure computer terminals
- Exam Language: English
- Exam Fees: Total exam fees range from $435 to $600 depending on ACRP membership status as well as when applicants apply for the exam (early-bird or regular). This includes an application fee and an exam fee. Note that all non-members will receive one year of ACRP membership upon passing the exam.
- Exam Dates: Spring 2024 Exam Dates: February 15 to May 15, 2024; Fall 2024 Exam Dates: July 15 to October 15, 2024
Renewal Process: According to the Maintenance of Certification Program through ACRP, certified individuals must participate in 24 contact hours or points of continuing education and activities every two years. Alternatively, they may retake the certification exam.
Careers for CRCs: Clinical research coordinators are employed by clinical research organizations under the direction of a principal investigator, who practices research under GCP guidelines. CRP certification can advance a career as a:
- Clinical Research Coordinator
- RN
- LVN
- LPN
- Research Nurse
- Independent Consultant/Contractor
Become a Certified Principal Investigator (CPI)
Certifying Agency: The Association of Clinical Research Professionals (ACRP)
Eligibility Requirements: Applicants must attest to having at least 3,000 hours of work experience performing the tasks and knowledge of the content areas of the CCRC exam. Experience older than ten years will not be considered. See below for exam content details.
All CPI candidates must also provide proof of employment as a principal investigator (PI) or sub-investigator (sub-I) on two clinical trials.
Up to 1,500 hours of work experience and one clinical study PI or sub-I position may be substituted for one of the following options:
- Current ACRP-CP, CCRC, CCRA, and CPI Designation OR
- Graduate from a clinical research education program accredited by the Council on Higher Education Accreditation (CHEA)
All applicants undergo a formal eligibility review process upon application.
Exam Details: The exam assesses proficiency in six core knowledge areas including:
| Content Areas | Percentage of Items on Exam |
|---|---|
| Scientific Concepts and Research Design | 18% |
| Ethical and Participant Safety Consideration | 24% |
| Product Development and Regulation | 13% |
| Clinical Trial Operations (GCPs) | 21% |
| Study and Site Management | 14% |
| Data Management and Informatics | 10% |
Examinees must show they can apply that knowledge to their professional responsibilities. Applicants can download a Detailed Content Outline (DCO) and a CPI Exam Handbook from the PI Certification page under “About the Exam”.
- Exam Format: 125 multiple-choice questions that test knowledge based on memory, application, and analysis of information
- Exam Duration: Maximum of three hours
- Exam Delivery: Secure computer terminals
- Exam Language: English
- Exam Fees: Total exam fees range from $435 to $600 depending on ACRP membership status and when applicants apply for the exam (early-bird or regular). This includes an application fee and an exam fee. Note that all non-members will receive one year of ACRP membership upon passing the exam.
- Exam Dates: Spring 2024 Exam Dates: February 15 to May 15, 2024; Fall 2024 Exam Dates: July 15 to October 15, 2024
Renewal Process: According to the Maintenance of Certification Program through ACRP, certified individuals may take the current certification exam or they must participate in 24 contact hours or points of continuing education and activities every two years.
Careers for CPIs: Principal Investigators hold a PhD or equivalent and are responsible for the ethical and safe conduct of clinical trials. CPI certification can advance a career as a Principal Investigator.
Become a Certified Clinical Research Professional (CCRP)
Certifying Agency: The Society of Clinical Research Associates (SOCRA)
Eligibility Requirements: Applicants must be working under Good Clinical Practice (GCP) guidelines and must meet one of the three following criteria sets:
- Two years of experience as a full-time clinical research professional or 3,500 hours of part-time experience during the last five years
- Associate, undergraduate, or graduate degree in clinical research and has a minimum of one year of full-time experience or 1,750 hours of part-time experience during the past two years as a clinical research professional
- Undergraduate or graduate certificate in clinical research with no less than 12 semester credit hours or totaling 144 credit hours from an academic institution of higher learning; an associate or bachelor’s degree in a pharmacy, science, health science, or related field; and a minimum of one year of full-time experience or 1,750 hours of part-time experience during the past two years as a clinical research professional
Applicants must submit an application, resume/CV, job description, verification of employment letter, and signed ethics statement.
Exam Details: The exam focuses on five content areas patterned after the 2017 SOCRA Job/Task Analysis. Examinees can download a detailed exam outline. Generally, candidates are tested on ethical principles, safety, informed consent; clinical trial protocol and amendments; institutional review board/ethics committee roles and responsibilities; investigator roles and responsibilities; and sponsor roles and responsibilities.
- Exam Format: 130 multiple-choice questions that assess understanding and application, 30 of which are beta testers and are not scored. Examinees must answer 72 of the 100 scored questions correctly to gain certification.
- Exam Duration: Maximum of four hours
- Exam Delivery: Paper and pencil format or computer-based testing
- Exam Language: English
- Exam Fees: Payment in full or three-year payment plans available; upon successful completion of the test, certified individuals receive three years of membership with any form of payment. Please note that there is a reduced retest fee for retaking the test within one year.
- Paper/Pencil (Members: $395, non-members: $450)
- Computer-Based Testing (Members: $395 + $115 within North America, +$175 outside North America, non-members: $450 + $115 within North America, +$175 outside North America)
- Exam Dates: Paper and pencil format dates run throughout the year in various locations. Computer-based testing is determined once the application is approved.
Renewal Process: Certification is valid for three years and must be renewed by application. CCRPs must complete 45 hours/credits of continuing education during this period, 22 of which must be related to clinical research. The other 23 hours may concern the professional’s specific career path. The fee to renew is $350.
Careers for CCRPs: Because clinical research professionals come from various professional paths, CRP certification can help advance careers in medical technology, nursing, statistics, biology, teaching, health records, administration, pharmacy, and other careers.
Become a Certified Research Administrator (CRA), Certified Pre-Award Research Administrator (CPRA), or Certified Financial Research Administrator (CFRA)
Certifying Agency: The Research Administrators Certification Council (RACC)
Eligibility Requirements: Candidates must comply with one of the following criteria sets:
- Holds a bachelor’s degree and has three years of experience in research or sponsored programs administration from a sponsor/recipient organization or from a self-funded organization OR
- Holds an associate’s degree and has five years of experience in research or sponsored programs administration from a sponsor/recipient organization or from a self-funded organization OR
- Has six years of professional experience in research or sponsored programs administration from a sponsor/recipient organization or from a self-funded organization; candidates falling into this category must complete a petition application including two letters of reference
The third option is only available through a special petition process and each petition is evaluated on a case-by-case basis.
Exam Details: The questions for each type of exam are obtained from previously certified individuals in those fields (CRA, CPRA, and CFRA). Exam sections consist of varying topics depending on the certification and include some of the following: project development and administration, legal requirements, research partnership and funding, project costs, fiscal compliance, and more.
- Exam Format: CRA (200 multiple choice questions); CPRA (250 multiple choice questions); CFRA (200 multiple choice questions)
- Exam Duration: Maximum of four hours
- Exam Delivery: Computer-based testing at certified PSI testing facilities
- Exam Language: English
- Exam Fees: $395
- Exam Dates:
- CRA: Spring – May 11 to May 25, 2024; Fall – November 2 to November 16, 2024
- CPRA: Spring – February 17 to March 2, 2024; Fall – August 17 to August 31, 2024
- CFRA: Spring – March 2 to March 16, 2024; Fall – September 7 to September 21, 2024
Tests are administered Monday through Saturday during the outlined two-week exam windows at various PSI locations throughout the U.S. and Canada.
Renewal Process: Certification is valid for five years. Renewal for another five years follows these requirements:
- CRA recertification requirements include 80 hours of continuing education, either taken or taught, or activities participated in, and three questions for use on a future certification exam. Educational activities include a variety of options as defined by RACC.
- CPRA recertification requirements include 80 hours of continuing education, 80 percent of which must be related to pre-award activities; or by retaking and successfully passing the CPRA exam.
- CFRA recertification requirements include 80 hours of continuing education, 80 percent of which must be related specifically to financial activities; or by retaking and successfully passing the CFRA exam.
Become a Certified Clinical Data Manager (CCDM)
Certifying Agency: The Society for Clinical Data Management (SCDM)
Eligibility Requirements: Applicants must meet one of the four following criteria sets:
- Holds a bachelor’s degree or higher and has a minimum of two years of full-time clinical data management experience
- Holds an associate’s degree and has a minimum of three years of full-time clinical data management experience
- Has four or more years of full-time clinical data management experience
- Has part-time work experience that equals or surpasses the full-time experience requirement
Applicants must submit an application as well as a CV.
Exam Details: The exam seeks to establish a universal standard of education, experience, and knowledge by which certified individuals would be recognized in the profession of clinical data management.
- Exam Format: 130 multiple-choice questions that assess competence and expertise in the field of clinical data management
- Exam Duration: Maximum of 3.5 hours
- Exam Delivery: Online, computer-based exams at testing centers
- Exam Language: English
- Exam Fees: Exam fees range from $125 to $325 depending on membership and country of origin. There is a reduced fee for retaking the test within one year
- Exam Dates: Exams are scheduled through Prolydian and are proctored virtually, so there is no need to travel to a testing site.
- Renewal Process: Renewal fees range from $60 to $150 depending on membership and country of origin. Certification is valid for three years. CCDMs must obtain 18 continuing education units (CEUs) within three years, 60 percent of which must be directly related to clinical data management training.
- Career Enhancement for CCDMs: Clinical data management professionals can enhance their career through certification by validating a specific skill set and knowledge that certifies them as experts in their field and shows the ability to mentor and prepare others for certification as a CDM.
Certification can benefit organizations because by hiring CCDMs, the company ensures best practices, efficiency, improved quality, comprehensive knowledge, excellence in the field, and a commitment of employees to professional development.
Learn More About Clinical Research Certification
Clinical research professionals wishing to learn more about clinical research certification can take a free online course offered by The National Institutes of Health. Topics covered by the course include:
- Roles and responsibilities of the investigator and the institution
- Regulatory issues
- Ethical issues involved in human subjects research
- Clinical investigators and the mass media
This course is offered 24 hours a day online and offers an exam at the end. Attendees who gain a score of 75 percent or higher on the exam will receive a certificate that verifies that the participant has gained an overview of the information presented in the course.
