This section introduces you to the Society of Clinical Research Associates’ Certification Program.
Clinical Research Professionals (CRPs) come from a wide variety of backgrounds. CRPs may have backgrounds in nursing, pharmacy, medical technology, business administration, health record maintenance, statistics, biology, teaching, or in other areas. CRPs work in various settings such as cooperative research groups; academic and private institutions; private offices; pharmaceutical, device, and biotechnology companies; Clinical Research Organizations (CROs); Site Management Organizations (SMOs); independent research and development organizations; or organizations involved in the management of clinical trials. These varying backgrounds and settings contribute to the unique knowledge and diverse expertise of CRPs.
The Society of Clinical Research Associates (SOCRA) has developed an International Certification Program in order to create an internationally-accepted standard of knowledge, education, and experience by which CRPs will be recognized as Certified Clinical Research Professionals (CCRP®s) in the clinical research community. The standards upon which this certification program is based have been set forth by this organization to promote recognition and continuing excellence in the ethical conduct of clinical trials.
SOCRA developed the Certified Clinical Research Professional Certification program to evaluate a CRP’s knowledge, understanding, and application of the conduct of clinical investigations involving humans in accordance with the International Conference on Harmonisation Guideline for Good Clinical Practice (E6) (ICH/GCP), ICH Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A), the United States Code of Federal Regulations (CFR) and the ethical principles that guide clinical research consistent with the principles of the Nuremberg Code, the Belmont Report and the Declaration of Helsinki. This Examination does NOT test on state, provincial, Ministry of Health, local, or institutional policy.
The SOCRA Certification Examination is offered in various locations throughout the U.S. and Canada, as well as at some international locations. Examinations are scheduled continuously throughout the year. Please visit the certification page of the SOCRA website at www.SOCRA.org for the most updated listing of exam sites and dates.
CCRP certification is awarded after two criteria are met: 1) a successful written application and 2) a passing CCRP examination score.
History / Background
The SOCRA "Certified Clinical Research Associate" (CCRA) examination was successfully implemented in August of 1995. In January, 2000, the certification designation changed from "Certified Clinical Research Associate" (CCRA) to "Certified Clinical Research Professional" (CCRP). The purpose of this change was to embrace the diversity of the SOCRA membership, recognizing that all may have different job titles, but all are clinical research professionals (CRPs). The certification continues to reflect a common, strong foundation of knowledge and practice in research regulations and Good Clinical Practice (GCP).