SOCRA

Introduction

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), 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.

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).

Program Overview

Purpose

SOCRA established the Certification Program for Clinical Research Professionals in order to create an internationally accepted standard of knowledge, education, and experience by which clinical research professionals will be recognized by the clinical research community. Those individuals so approved may use the title “Certified Clinical Research Professional” or “CCRP® (SOCRA)”

Scope

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 certification is not intended for those professionals working exclusively under Good Laboratory Practice (GLP) and/or Good Manufacturing Practice (GMP) regulations.

Standards of Practice

It is the goal of the Society of Clinical Research Associates to encourage members, and assure the competency of certified members, in their knowledge, understanding, and application of the conduct of clinical investigations involving humans in accordance with the ICH Guidelines, the U.S. Code of Federal Regulations, and the ethical principles that guide clinical research consistent with the principles of the Nuremberg Code, the Belmont Report, and the Declaration of Helsinki. Members are expected to adhere to national, state, local and provincial regulations and to international guidelines published by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and all applicable Federal, state and local laws and policies.

Standards of Practice include an understanding of and application of basic concepts of Good Clinical (Research) Practice, including:

• The Nuremberg Code
• The Belmont Report
• The Declaration of Helsinki
• 21 U.S. Code of Federal Regulations – Parts 11, 50, 56, 312, 812
• 45 U.S. Code of Federal Regulations – Part 46
• ICH GCP Guideline for Good Clinical Practice (E6), and
• ICH Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A)

Definition of a Clinical Research Professional

A clinical research professional’s (CRP) practice is guided by one or more aspects of the principles of Good Clinical Practice (GCP).A CRP may function as a clinical investigator, sub-investigator, clinical researcher, research nurse, pharmacist, administrator, coordinator, consultant, data manager, quality assurance manager, regulatory affairs manager or educator in clinical trial management.

The duties of a CRP may include data collection, analysis, or monitoring; case management of protocol participants; recruitment and enrollment of human subjects; protection of subjects and subjects’ rights; development of informed consent documents; preparation of adverse event experience reports; construction or monitoring of case report forms; maintenance of drug accountability records; development of grants and budgets; preparation of reports; educating other healthcare professionals, patients or families about clinical trials; protocol development; program administration; or auditing research program.

A CRP would not include professionals working exclusively under Good Laboratory Practice (GLP) and/or Good Manufacturing Practice (GMP) regulations.

Certification Program Policies

Appeals

All appeals must be sent in writing to SOCRA Re: Certification Appeal by e-mail to office@socra.org , mailed to 530 West Butler Avenue, Suite 109 Chalfont, PA 18914 USA, or faxed to: (215) 822-8633.

Certification of Honesty

Falsification or misrepresentation of application information will invalidate the applicant’s certification status. This would include disapproval of the application or revoking of certification.

Confidentiality Statement

The SOCRA Certification Committee (the “Committee”) will take all reasonable measures to ensure that any material, reports, proceedings, and/or hearings related to the certification process shall remain confidential between the Committee and the candidate except as required by law, authorized in writing by the candidate, or as otherwise provided in the Committee’s Policies and Procedures.

Policy of Non-Discrimination

SOCRA does not discriminate on the basis of gender, race, color, age, marital status, sexual orientation, national origin, religion, or disability.

Special Needs / Disability Accommodation Policy

SOCRA – Society of Clinical Research Associates supports the intent of, and complies with the Americans with Disabilities Act (“ADA”). The Society of Clinical Research Associates will take steps reasonably necessary to make its assessment programs accessible to persons with disabilities covered by the ADA. An applicant may request a change in certification procedures or process due to a disability, handicap, or other reason. Appropriate and effective modifications and/or auxiliary aides will be provided to persons with such disability, handicap, or other reason unless doing so would impose an undue burden on the Society of Clinical Research Associates’ programs or fundamentally alter the measurement of skills or knowledge that the programs are intended to test. The Society of Clinical Research Associates certification examination does not discriminate against any candidate based on age, sex ethnic origin, religion, race, disability or marital status.

SOCRA will make every effort to accommodate applicants with special needs. If the applicant has special physical or testing needs due to a disability, handicap, or other reason, the applicant should attach a written request for accommodation with the certification application and at least six weeks in advance of the examination date. The written documentation should include a diagnosis or description of the disability or special need, the current level of functioning, and the requested accommodation. This statement must be written by a qualified medical professional (preferably a physician) and should be submitted on the letterhead of the medical professional or their institution or organization.

All special arrangements must be made and agreed upon in advance; such arrangements cannot be made at the time an examination is given. The Society of Clinical Research Associates will make the final determination as to the necessary accommodations for an individual with a verified disability.

For individuals with physical, visual or learning disabilities requiring an extended test time, there is no accommodation for untimed testing. Time and a half (6 hours) is appropriate accommodation for most disabilities. Double time (8 hours) may only be granted in special circumstances with the recommendation of qualified professionals.

At this time, SOCRA does not have an auditory examination for the visually impaired.

Test Center Policies & Procedures

Test Center Policies and Procedures may be found here.

Removal of CCRP Credential

Removal / Suspension

The CCRP® credential will be automatically suspended / removed if the certificant;

• Fails to maintain current membership in SOCRA
• Fails to apply for renewal of certification at the end of their certification period
• Fails to meet all of the requirements for recertification

Revocation

The CCRP® credential will be automatically suspended / removed if the certificant;

• Fails to maintain current membership in SOCRA
• Fails to apply for renewal of certification at the end of their certification period
• Fails to meet all of the requirements for recertification