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Certification for CCRP

Click Here for Recertification information test.

Certification Declares Professionalism and Expertise!

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 purpose of this reference manual is to be a resource to assist you with your preparation for the SoCRA Certification Examination; it is not an all-inclusive resource.

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.

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Certification Program Overview

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).

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.

Summary of Certification Activities - Year 2011

  • # exam sites hosted: 97
  • # candidates took certification exam: 2,067
  • % passed exam: 81.5
  • # CCRPs recertified: 1,855

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CCRP® Certification Examination

Background Information

Clinical research professionals come from a wide variety of backgrounds with even more varied job descriptions. Some clinical research professionals are MDs, while other are RNs; some may have a degree in medical technology, business administration, health information management, statistics, biology, teaching, or other areas. Every one of these backgrounds brings special areas of expertise to the field of clinical research. Each institution and discipline has unique requirements.

Despite the varied backgrounds and job descriptions, all clinical research professionals are guided by a common framework of regulations, guidelines and ethical principles in the conduct of clinical research. Therefore, the examination is designed to assess the applicant’s ability to apply the U.S. Code of Federal Regulations, ICH Guidelines, and ethical principles that guide the conduct of clinical research under the scope of GCP, highlighted in the standards of practice.

Examination Development

The Certification Examination has been developed by the SoCRA Certification Committee and SoCRA Certified Clinical Research Professionals (CCRPs) who have demonstrated expertise in the development, management, and administration of clinical trials. These clinical research subject matter experts (SMEs) come from diverse backgrounds and job descriptions to reflect the composition of SoCRA membership.

The test questions are designed to be straightforward and easily understood. The questions are reviewed by experts in test question development and SoCRA language representatives for fairness and readability.

The Certification Examination is evaluated and updated at least annually in order to assure that it is up-to-date and reflective of the current regulatory environment in which clinical trials are performed.

The certification exam content areas have been reviewed and validated through completion of a Job/Task Analysis. A copy of the Job / Task Analysis summary is available by request through the SoCRA administrative office.

Examination Validation

The exam is statistically and psychometrically validated by an independent consultant. The Certification Committee evaluates the results from the statistical/psychometric evaluations and updates the exam, as needed.

The examination pass/fail score, or “cut score”, is statistically validated by a panel of experts using the modified Angoff method. The current cut score is 80% and requires that the candidate correctly completes 108 out of the 135 examination questions.

Examination Content

Four major subject areas are covered in the CCRP® certification examination. The examination outline includes examples of content that may be covered on the examination in the four major subject areas. Each major subject area will be included in each examination, but specific questions will vary from one exam version to another. A percentage of questions from each subject area may change slightly from one examination to another. Each question is weighted equally. Satisfactory completion of the SoCRA certification examination indicates that the applicant has attained the minimum level of education and experience required of a clinical research professional. To achieve a passing grade a candidate must correctly answer a minimum of 108 questions (80%).

The examination is made up of 135 multiple choice and true/false questions. The examination contains case studies that relate to clinical research practice. The case studies are intended to evaluate a candidate’s ability to abstract data and do not require clinical experience. The questions are formulated to be straight-forward and easily understood.

The certification examination is offered in the English, French and Japanese languages.

Certification Examination Competency Areas

SoCRA has developed a standard core series of competencies that reflects the basic knowledge required of clinical research professionals. These core competencies are assessed by the CCRP® certification examination. The competencies are as follows:

  • Identify and differentiate the foundations and principles of clinical research ethics.
  • Demonstrate knowledge of laws, regulations, guidance, and standard operating procedures and their application to regulated clinical research.
  • Distinguish and define the responsibilities of sponsors, monitors, and investigators according to the principles of ICH/GCP and the Code of Federal Regulations.
  • Identify and apply the regulations and guidance as they relate to informed consent, IRB/EICs, and financial disclosure.
  • Identify the principles of study design, study closure, and record retention.
  • Demonstrate knowledge and application of safety reporting requirements.
  • Demonstrate the ability to utilize critical thinking skills in practical applications.

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CCRP® Examination Outline

Conduct of Clinical Trials

  • Roles and responsibilities of sponsors and investigators
  • Study development, design, trial phases, blinding
  • Study initiation
  • Protocol development
  • Protocol amendments
  • Subject recruitment/enrollment
  • Study visits, assessments, procedures
  • Source documentation
  • Develop/complete/verify case report forms (paper/electronic)
  • Essential documents
  • Investigational product accountability
  • Safety assessment, documentation and reporting (i.e. Adverse events, serious adverse events, unanticipated adverse device effects)
  • Reporting requirements (annual reports, protocol, protocol amendments, and adverse events)
  • Monitoring and quality assurance
  • Audits
  • Record retention
  • Study closeout

Institutional Review Boards/ Independent Ethics Committees (IRBs/IECs) and Regulation

  • Roles and responsibilities of IRB/IEC
  • IRB/IEC membership
  • Standard Operating Procedures
  • IRB/IEC review and approval
  • Vulnerable patients and children
  • Record retention
  • Study closeout

Ethical Issues

  • Ethical principles with their foundation in Nuremberg Code, Belmont Report and Declaration of Helsinki
  • Informed Consent/Assent
  • Research misconduct
  • Disclosure of Financial Information

Abstracting Information from Medical Records

  • Abstracting data and verifying data from source documents related to investigational product accountability, dosing, eligibility of subjects, informed consent, study related visits, clinical reports, and clinical assessments

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Certification Program Qualifications and Submission Process

Eligibility

The applicant must be a current member of SoCRA, working with Good Clinical Practice (GCP) guidelines under IRB/IEC/REB-approved (or specifically exempted) protocols.

The applicant must meet one of the following criteria:

  • Category 1: Have two years of experience as a full-time Clinical Research Professional (or have 3,500 hours part-time) during the last five years OR
  • Category 2: Hold a degree in "Clinical Research" from an Associate, Undergraduate, or Graduate Degree Program, AND have completed a minimum of one year of full-time experience (or 1,750 hours part-time) during the past two years as a Clinical Research Professional OR
  • Category 3: Hold an Undergraduate or Graduate Certificate in “Clinical Research” with a curriculum of no less than 12 semester (credit) hours or totaling a minimum of 144 credit hours from an academic institution of higher learning (community college, college or university) AND hold an Associate’s or Bachelor’s Degree in a science, health science, pharmacy or related field AND have completed a minimum of one year of full-time experience (or 1750 hours part-time) during the past two years as a Clinical Research Professional.

NOTE: Most candidates will be eligible under Category 1. If you have completed two (2) years of full-time employment as a clinical research professional in the past five years, you will NOT need to provide supporting documentation for your educational experience.

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Registration Procedure and Fee – How to Apply

The applicant must submit the following:

  • A completed certification application (NOTE: ALL Candidates for SoCRA CCRP Certification must complete and submit the Certification application.) You may also download the full certification brochure here.
  • A completed membership application form (or include member ID #).
  • The applicant's resume or CV documenting their employment in clinical research.
  • The applicant's official job description issued by the institution or employer.
  • As applicable, the applicant's transcript documenting graduation with an Associate's or Bachelor's degree in "Clinical Research" OR completion of a Certificate program from an undergraduate or graduate "Clinical Research" curriculum of no less than 12 semester (credit) hours at an academic institution of higher learning (community college, college or university).
    Submit Form 1011 or Form 1022 with appropriate transcript and syllabus.
    NOTE: Form 1011 is required ONLY for candidates applying under Eligibility Category #2. Please see Eligibility Category #2 for more information.
    Click here to view/print Form 1022 in Adobe PDF Format.
    NOTE: Form 1022 is required ONLY for candidates applying under Eligibility Category #3. Please see Eligibility Category #3 for more information.
  • A letter of reference, on organizational letterhead signed by a supervisor or human resources representative, documenting position titles, and dates of employment. If experience spans multiple positions, each position must be substantiated through submitted documentation and references.
  • Payment to SOCRA for the examination application fee - $195 (US Funds)

All of the materials must be included and forwarded to the SoCRA administrative offices a minimum of six weeks prior to the test date for US or Canadian exam locations or eight weeks prior to the test date for non-US/non-Canadian locations. Upon approval of the application, the applicant will receive notice of approval and a copy of the SoCRA Certification Program Reference Manual. Once the application is approved, fees are non-refundable.

A complete application packet must be received by the deadline date as stated on the examination schedule. Applications received after the deadline will be considered for an alternate examination date designated by the applicant. SoCRA is not responsible for lost or misdirected applications.

PLEASE NOTE:

  • SoCRA will not be able to consider candidates who are unable to provide the requested supporting documentation regarding their experience in clinical research.
  • Enrollment in specific exam venues may be limited due to room size and may require enrollment to be closed prior to the registration deadline. Therefore please apply early to secure a space. Please do not book non-refundable travel prior to confirmation of enrollment.
  • Applications will be reviewed within 5 business days of receipt. However, enrollment is NOT confirmed until the application is complete and has been approved. Space will NOT be held in a specific exam site/ date for pending applicants.
  • Once the application is approved, NO REFUNDS will be issued. The applicant may be offered an opportunity to reschedule within a specified time frame.
  • Once approved, a certification program reference manual and enrollment confirmation letter will be mailed to the applicant. Then, three weeks prior to the testing date, the applicant will be mailed a VERIFICATION letter with details regarding the exam policies and location information. The applicant MUST bring this VERIFICATION letter and photo ID in order to be admitted to the examination site.
  • Exam results will be mailed to the applicant within 6 weeks of the testing date. Exam results WILL NOT be given by phone, email or fax.
  • Any questions regarding the eligibility requirements should be directed to the SoCRA Administrative Office.

If you are retesting:

  • If you are re-testing within 1 year of the original test date, you may not need to resubmit your supporting documentation (job description(s), employment verification letter(s), etc.). Contact the SoCRA office by email at socramail@aol.com to confirm.
  • No waiting period is required for re-testing
  • To register, complete an application form and submit with payment to the SoCRA office.

Examination Schedule

View the Examination Schedule online or in PDF.

Special Needs / Disability Accommodation

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.

Refund Policy

The fee is refundable if the application process is unsuccessful. For qualified applicants who apply for an examination, the fee is nonrefundable. If the applicant is unable to take the examination on the date specified, the applicant must formally notify SoCRA in writing that they will be unable to sit for the examination. The applicant will then have one year, from the originally scheduled examination date, to take the examination at another site. If the applicant fails to take the exam within that specified period, he/she will forfeit their examination fee and must submit a new application and fee when reapplying.

Appeals

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

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Preparing for the Examination

How to Prepare for the Examination

Content areas on the Examination that deals with topics concerning your daily job requirements should not require extensive study on your part; it is anticipated that this is part of your working knowledge. Content areas appearing on the Examination that are not part of your daily job requirements may require some research and study. For instance, if you do not deal with Institutional Review Boards (IRB), you will want to study the requirements of this aspect of clinical research. If you are from a country other than the United States, you will need to study the United States Federal Regulations concerning clinical trials. If you work in the United States, you will need to study the International Conference on Harmonisation (ICH) Guidelines. (Most of these regulations cross national borders; however, this examination will relate specifically to United States federal regulations.)

Please remember that the Examination assesses your knowledge and understanding of the United States Code of Federal Regulations and the International Conference of Harmonisation E6 & E2A Guidelines. It does not assess state, local, provincial, Ministry of Health, or institutional policy.

Explanation of Hierarchy of Federal Food, Drug, and Cosmetic Act vs. Regulations vs. Guidance

The Federal Food, Drug, and Cosmetic Act (FD&C Act) is United States (US) federal law enacted by Congress (statutory law). It and other federal laws establish the legal framework within which the US Food and Drug Administration (FDA) operates. The FD&C Act can be found in the United States Code (U.S.C), which contains all general and permanent U.S. laws, beginning at 21 U.S.C. 301.

The FDA develops regulations based on the laws set forth in the FD&C Act or other laws under which FDA operates. FDA follows the procedures required by the Administrative Procedure Act, another federal law, to issue FDA regulations. FDA regulations are also federal laws, but they are not part of the FD&C Act. The regulations are legally binding. (administrative law)

FDA guidance describes the agency’s current thinking on a regulatory issue. Guidance is not legally binding on the public or FDA. The Good Guidance Practice regulation can be found at 21 CFR 10.115

21 CFR 10.115 (b) What is a guidance document? (1) Guidance documents are documents prepared for FDA staff, applicants/sponsors, and the public that describe the agency's interpretation of or policy on a regulatory issue.

Certification Program Reference Manual

Once a candidate’s certification application has been approved, a complimentary copy of the certification program reference manual will be sent.

The purpose of this reference manual is to help you prepare for the Examination. It is a resource to assist you with your preparation however; it is not an all-inclusive resource. See the Examination Content section of this chapter for a detailed description of the concepts included in the examination.

Please note: The Health Canada Sections are printed as reference material. You will NOT be tested on content related to this section on the certification examination.

Please note: The examination assesses your knowledge and understanding of the FDA regulations. You will not be tested on FDA guidance. However, some of these documents published by the FDA may be helpful in explaining concepts.

The reference manual is also available separately for purchase - $50 USD.

Additional Resources

Applicants are encouraged to consider information provided in applicable journal articles, textbooks, manuals, workshops, or meetings specific to clinical trials and investigational drugs.

Disclaimer: The additional resources listed below may be helpful to you in your studies. However, please take note of the publication dates, as these references may contain outdated material. Please remember that the Examination assesses your knowledge and understanding of the United States Code of Federal Regulations and the International Conference of Harmonisation E6 and E2A Guidelines.

The following is a list of additional resources that you may wish to include in your study:

  • Guide to Clinical Trials, Spilker, B., (Lippencott-Raven Publishers, 1991)
  • Foundation of Clinical Research, Center for Clinical Research Practice, Inc., (Center for Clinical Research Practice, Inc., 2001)
  • Investigator's Handbook, Manual for Participation in Clinical Trials of Investigational Agents Sponsored by the Division of Cancer Treatments, National Cancer Institute (1986).
    http://ctep.cancer.gov/investigatorResources/investigators_handbook.htm (Updated January 24, 2012)
  • Fundamentals of Clinical Trials, Feidman, L.; Furgerg, C.; DeMets, D., (Springer-Verlag Publishers, 1998)
  • Protecting Study Volunteers in Research, Cynthia McGuire Dunn, M.D, Gary Chadwich, PharmD
  • The CRC’s Guide to Coordinating Clinical Research. Karen E. Woodin, Ph.D.
  • Conducting Clinical Research, Judy Stone, MD.

The following is a list of websites that you may wish to include in your study:

  • FDA Website: www.fda.gov
  • ICH Website: www.ich.org
  • Guidance for Industry - E6 Good Clinical Practice: Consolidated Guidance: View/print the "Guidance for Industry" (198 KB) (PDF)
  • OHRP Website: www.hhs.gov/ohrp/
  • Information Sheet Guidance for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors.
    Website: Click Here.

(There have been new FDA Regulations enacted since the publication of these documents and the documents have not been updated to reflect the new regulations; however, they may be helpful in clarifying concepts)

Sample Questions

The correct answers are bolded.

1. What is the minimum number of Institutional Review board (IRB) members?
a. 3
b. 5
c. 6

2. The initial drug dose is 110mg/m2. Due to toxicity, the drug needs to be decreased by 30%. The new dosage would be?
a. 91
b. 100
c. 77

3. The responsibility for ensuring that the investigator understands a clinical trial lies with:
a. The FDA
b. The IRB
c. The Sponsor

4. Significant risk device is defined as an investigational device that is:
a. Intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject.
b. Purported or represented to be for a use in supporting or sustaining human life and presents a potential risk to the health, safety, or welfare of a subject.
c. For a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject.
d. All the above

5. A purpose of monitoring clinical trials is to verify that:
a. The rights, safety, and well-being of human subjects are protected
b. Investigators receive adequate payment for their participation in the clinical trial
c. The investigator has received annual reports from the sponsor
d. The regulatory agency has received all case history information of subjects enrolled on the clinical trial

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CCRP® Certification Program Policies and Procedures

Test Center Policies and Procedures

What to Bring to the Exam

To be admitted to the test center, you must bring:

  • Your verification letter
  • One form of identification that bears your photograph and signature. Acceptable forms of ID may include; a driver’s license, military ID, employee ID, or passport. The name listed on the ID must match your name as it appears on the verification letter.
  • Three or four sharpened, soft lead (No. 2) pencils and a good eraser. Pencils and/or erasers will not be provided. Mechanical pencils are not recommended.
    We suggest that you dress in layers to adapt to fluctuating room temperature.

What NOT to Bring to the Exam

  • No food or drink will be allowed in the testing room.
  • The use of electronic devices is strictly prohibited, including the use of calculators, cell phones, smart phones, pagers, photographic devices and/or other electronic or communication devices.
  • Visitors are not permitted in the testing room for any reason.
  • Please note: If you have a medical need that necessitates food or drink, use of a medical device, or other special accommodation during the exam, contact the SoCRA Administrative office to discuss as soon as possible and at least one week prior to the exam.

Before You Enter the Test Center

  • Visit a restroom before checking in at the test center.
  • You will be admitted to the test center only if your name is on the exam roster and if you present a valid verification letter and an appropriate photo ID.
  • Be sure to arrive by the registration time indicated on your verification letter.
  • Any electronic devices (cell phone, electronic devices) must be turned off and stored on the floor below your seat (backpack/purse) in the test center.

Once the Exam Begins

Test Center Policies and Procedures

  • You will be monitored by the facilitator for test security and fairness. The facilitator is NOT permitted to answer ANY questions.
  • No breaks are scheduled. Candidates will not be permitted to leave the exam room without the exam facilitator’s permission. Lost time will not made up. If you must leave the room to use the restroom, you are not permitted to take anything with you, including pocketbooks, cell phones, or any other personal item. Outside communication is strictly prohibited including use of cell phones, pagers, and/or other communication devices.
  • You will have 4 hours to complete the examination. The examination consists of 135 multiple choice/true false questions. You must correctly answer 108 questions to receive a passing grade (80%). There is no penalty for incorrect answers; therefore, it is to your advantage to answer every question. The facilitator will inform you when there are 30 minutes remaining. At the end of 4 hours, the facilitator will collect any remaining exam materials.
  • No testing aides are permitted. Calculators, personal digital assistants (PDAs), smart phones, books, reference material, scratch paper and/or other aides are not permitted. Scratch work may be done in the margins of the examination booklet.
  • All communication is prohibited during the examination including talking and use of cell phones, pagers, and/or other communication devices.
  • The examination facilitator may dismiss a candidate from the test center at any time for any of the following reasons:
    • Creating a disturbance
    • Using or attempting to use an electronic device/unauthorized testing aide
    • Using any outside communication
    • Giving or receiving help on the examination
    • Failing to follow testing procedures and/or instructions
    • Attempting to remove examination materials or notes from the test center
    • Impersonating another candidate

When You Have Completed the Examination

You must sign and return all examination materials including the exam booklet, medical records booklet, answer sheet, and instruction packet. You may leave once you have turned in all materials and the exam facilitator confirms that you have signed your name in the sign out column of the exam roster.

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 on Non-Discrimination

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

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Examination Results

Graded Examination

Scoring of the examination is completed electronically by an independent outside testing agency. Examinations are batch processed, and grades will be e-mailed approximately four to six weeks after your exam date. Successful applicants will receive a CCRP® certificate approximately four weeks after the grade letter has been received.

Exam Review

Candidates who do not achieve a passing score may request an exam review which outlines the exam competency areas where the candidate was unsuccessful. A written request for exam review must be sent to the SoCRA Certification Committee by emailing socramail@aol.com within three months of the examination date.

Appeals

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

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Maintenance of Certification

Term of Certification / Certification Period

The certification period is 3 years, beginning on the date of most recent certification and ending on certification expiration date. All CE must be accrued during this time period.

Continuing Education (CE) Requirements

Detailed information regarding CCRP maintenance, continuing education requirements, and re-certification can be found on the recertification webpage.

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Recertification

Renewal of Certification

Detailed information regarding CCRP maintenance, continuing education requirements, and re-certification can be found on the recertification webpage.

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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

Revocation of certification may occur for any of the following reasons:

  • Falsification of the certification application;
  • Falsification of any information requested by SoCRA;
  • Lack of continued membership in the organization; or
  • Misrepresentation of the CCRP® (SoCRA) credentials.

Appeals

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

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Important Reminders

  • Register early. Applications received after the deadline will be considered for an alternate examination date designated by the applicant. Fill out the application completely and legibly. Applications that are incomplete or illegible will not be accepted.
  • Enclose payment with your application. If your employer is paying your fee, please obtain the check from them to include with your application. This will prevent rejection of your application because of late payment. Applications and corroborating documentation must be completed in the English language.
    Requests for special accommodations must be made in writing to the Certification Committee if you have a disability that prohibits you from taking the examination under standard conditions. Your written request, along with written confirmation from your physician, must accompany your application form.
  • Once your application has been approved and payment has been processed, you will receive a letter acknowledging your acceptance along with the SoCRA Certification Program Reference Manual. Approximately two weeks prior to the examination, you will be sent a verification letter confirming approval to take the examination, the examination time, date and location. This letter must be presented to the facilitator for admission to the test site along with a picture ID card (driver’s license, employee badge, etc.). (Driver's license is suggested)
  • Arrive a minimum of 15 minutes prior to the exam start time for check in, as indicated on your verification letter. No one will be admitted to the test site after the door has been closed.

Good luck.

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Schedule an Exam at Your Site

If you are interested in having SoCRA come to your institution for an examination, please complete the Exam Scheduling Form after first considering:

  • A date not already on the schedule and at least 3-4 months out (see current exam schedule)
  • Attendance of a minimum of 10 with availability to any interested SoCRA member
  • A room to accommodate a minimum of 25 persons set classroom style with 2 persons/6 ft. table

Please contact the SoCRA office and ask to speak with the Administrative Director with any questions.

View / Download the Certification Examination Scheduling Request Form for exams within the US or Canada (PDF format)

View / Download the Certification Examination Scheduling Request Form for International Exams (exams outside of the US or Canada) (PDF format)

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Examination Schedule

2013
Examination Testing Site
Exam Location
Reg. Deadline
Time
1/16/2013
Montreal, Quebec in conjunction with McGill University McGill University and SoCRA's Prep & Review Course McGill University
12/5/2012
8:30 AM to 1 PM
1/19/2013
Las Vegas, NV in conjunction with SoCRA's Site Management
Workshop
Bally's Las Vegas
12/7/2013
8 AM to Noon
1/24/2013
San Diego, CA in conjunction with Radiation Therapy Oncology Group (RTOG) Manchester Grand Hyatt Hotel
12/13/2012
8 AM - Noon
1/25/2013
New York, NY in conjunction with Memorial Sloan Kettering Cancer Center Rockefeller Auditorium (RRL-120)
12/14/2012
9:30 AM to 1:30 PM
1/26/2013
Tokyo, Japan in conjunctions with SoCRA's Japan Chapter Bunkyo Civic Hall
11/30/2012
12:30 PM to 4:30 PM
1/29/2013
Orlando, FL in conjunction with MD Anderson Cancer Center Orlando MD Anderson Cancer Center Orlando
12/18/2012
10 AM to 2 PM
2/2/2013
Houston, TX in conjunction with the SoCRA Houston Chapter The Methodist Hospital
12/21/2012
9 AM to 1 PM
2/7/2013
San Antonio, TX in conjunction with CTRC at the UT Health Science Center CTRC at UT Health Science Center
12/27/2012
9 AM to 1 PM
2/8/2013
Oklahoma City, OK in conjunction with the SoCRA Central Oklahoma Chapter Robert S Bird Library Auditorium
12/28/2012
9 AM to 1 PM
2/9/2013
Buffalo, NY in conjunction with Roswell Park Cancer Institute Gaylord Cary Meeting Room
12/31/2013
8 AM to Noon
2/15/2013
Seoul, South Korea in conjunction with Yonsei University Health System and the SoCRA's Prep & Review Course Grand Hilton Seoul Hotel
12/20/2012
8 AM to Noon
2/18/2013
Spartanburg , SC in conjunctiaon with Spartanburg Regional Healthcare System Clinical Research Dept Cancer Center Auditorium
1/7/2013
9 AM to 1 PM
2/19/2013
Toronto, CA in conjunction with Hospital for Sick Children Hospital for Sick Children
1/8/2013
1 PM to 5 PM
2/23/2013
Los Angeles, CA in conjunction with SoCRA's SOP, Monitoring, &
Certification Prep & Review Course
The Westin Bonaventure
1/11/2013
8 AM to Noon
3/1/2013
Columbus, OH in conjunction with the Ohio State U College of Med Office of Research Biomedical Research Tower
1/18/2013
1 PM to 5 PM
3/2/2013
Milwaukee, WI in conjunction with the Medical College of Wisconsin and the SoCRA Prep & Review Course Medical College of Wisconsin
1/18/2013
8 AM to Noon
3/8/2013
Dallas, TX in conjunction with SoCRA's FDA Regulation Workshop Sheraton Dallas Hotel
1/25/2013
8 AM to Noon
3/13/2013
Philadelphia, PA in conjunction with SoCRA's Clinical Science
Course
Loews Philadelphia
1/30/2013
5:30 PM to 9:30PM
3/16/2013
Indianapolis, IN in conjunction with Indiana U School of Med, Dept of Peds, Section Adolescent Med Health Information & Translational Sci Building
2/2/2013
8 AM to Noon
3/22/2013
Richmond, VA in conjunction VA Commonwealth Univ Cntr for Clin Translational Research Medical Science Building
2/8/2013
Noon to 4 PM
3/23/2013
Las Vegas, NV in conjunction with SoCRA's Clinical Trial
Management Workshop
Bally's Las Vegas
2/8/2013
8 AM to Noon
3/26/2013
Galveston, TX in conjunction with the University of TX Medical Branch Rebecca Sealy Hospital
2/12/2013
8:30 AM to 12:30 PM
4/6/2013
Chicago, IL in conjunction with Ann & Robert H Lurie Children's Hospital of Chicago Ann & Robert - Lurie Children's Hospital
2/23/2013
9 AM to 1 PM
4/11/2013
Detroit, MI in conjunction with Karmanos Cancer Institute - Clinical Trials Karmanos Cancer Institute Clinical Trials Office
2/28/2013
1 PM to 5 PM
4/13/2013
Toronto, ON in conjunction with SoCRA's Site Management
Workshop
Delta Chelsea Hotel
3/1/2013
8 AM to Noon
4/17/2013
Dallas, TX in conjunction with Texas Scottish Rite Hospital and SocRA's Prep & Review Course Texas Scottish Rite Hospital for Children
3/6/2013
9 AM to 1 PM
4/20/2013
Marshfield, WI in conjunction with Clinical Research Center,
Marshfield Clinical Research Foundation
Lawton Building
3/8/2013
8 AM to Noon
4/22/2013
Nashville, TN in conjunction with the Greater Nashville TN SoCRA Chapter Vanderbilt University Medical Center
3/11/2013
9 AM to 1 PM
4/26/2013
Toronto, ON Canada in conjunction with the NCIC Clinical Trials Group The Delta Chelsea Hotel
3/15/2013
8 AM to Noon
4/27/2013
San Diego, CA in conjunction with SoCRA's Legal & Ethical Human
Protections Workshop
Westin San Diego
3/15/2013
8 AM to Noon
5/1/2013
Philadelphia (suburb), PA in conjunction with Fox Chase Cancer Center Clinical Trials Operations Fox Chase Cancer Center
3/20/2013
9:30 AM to 1:30 PM
5/4/2013
Houston, TX in conjunction with the SoCRA Houston Chapter The Methodist Hospital
3/22/2013
9 AM to 1 PM
5/6/2013
Rochester, MN in conjunction with Mayo Clinic Office of
Research Education
Mayo Clinic Siebens Building
3/25/2013
8 AM to Noon
5/7/2013
Fort Lauderdale, FL in conjunction with Holy Cross Hospital and The SoCRA Prep & Review Course Holy Cross Hospital
3/25/2013
9 AM to 1 PM
5/8/2013
Boston, MA in conjunction with MAGI's Clinical Research 2013 Conference Westin Copley Plaza
3/26/2013
1 PM to 5 PM
5/11/2013
Scottsdale, AZ in conjunction with SoCRA's Device Workshop Chaparral Suites
3/29/2013
8 AM to Noon
5/17/2013
Seattle, WA in conjunction with SoCRA's FDA Regulations
Workshop
Renaissance Seattle Hotel
4/5/2013
8 AM to Noon
5/18/2013
Minneapolis, MN in conjunction with CTSI of the University of Minnesota University of Minnesota
4/5/2013
10 AM to 2 PM
5/20/2013
Aurora, CO in conjunction with the University of Colorado, Clinical Research Support Center Anschutz University of Colorado - Anschutz Medical Center
4/8/2013
8 AM to Noon
5/24/2013
Memphis, TN in conjunction with St. Jude Children's Research
Hospital
St. Jude Board Room
4/12/2013
8:30 AM to 12:30 PM
5/31/2013
Little Rock, AR in conjunction with the University of Arkansas for Medical Sciences and the SoCRA AR Chapter University of AR for Medical Sciences
4/18/2013
9 AM to 1 PM
6/1/2013
Columbia, SC in conjunction with South Carolina Oncology Associates, PA South Carolina Oncology Associates, PA
4/19/2013
9 AM to 1 PM
6/7/2013
Sacramento, CA in conjunction with UC Davis Clinical & Translational Science Center CTSC Auditorium
4/26/2013
1 PM to 5 PM
6/8/2013
Toronto, ON in conjunction with SoCRA's SOP and Certification
Prep & Review Course
Delta Chelsea Hotel
4/26/2013
8 AM to Noon
6/10/2013
Virginia Beach, VA in conjunction with the SoCRA Southeastern VA Chapter Life Net Health
4/29/2013
8 AM to Noon
6/13/2013
Philadelphia, PA in conjunction with Radiation Therapy Oncology Group (RTOG) The Loews Philadelphia Hotel
5/2/2013
8 AM to Noon
6/15/2013
Vancouver, BC in conjunction with SoCRA's Finance &
Productivity and Monitoring Workshops
The Renaissance Hotel
4/3/2013
8 AM to Noon
6/22/2013
Jacksonville, FL in conjunction with Mayo Clinic Jacksonville Mayo Clinic Kinne Auditorium
5/10/2013
9 AM to 1 PM
6/29/2013
Indianapolis, IN in conjunction with Indiana U School of Med, Dept of Peds, Section Adolescent Med Health Information & Translational Sci Building
5/18/2013
8 AM to Noon
7/13/2013
Philadelphia, PA in conjunction with SoCRA's Site
Management Workshop
Radisson Warwick Philadelphia Hotel
5/31/2013
8 AM to Noon
7/18/2013
San Antonio, TX in conjunction with Gynecologic Oncology Group San Antonio Marriott Rivercenter
6/6/2013
8 AM to Noon
7/23/2013
Ann Arbor, MI in conjunction with the University of Michigan University of Michigan Cardiovascular Center
6/11/2013
Noon to 4 PM
7/24/2013
Denver, CO in conjunction with SoCRA's Clinical Science Course Crowne Plaza Denver
6/12/2013
5:30 PM to 9:30 PM
8/3/2013
Houston, TX in conjunction with the SoCRA Houston Chapter The Methodist Hospital
6/21/2013
9 AM to 1 PM
8/7/2013
Duarte, CA in conjunction with SoCRA Greater Los Angeles Chapter and City of Hope City of Hope
6/26/2013
1 PM to 5 PM
8/9/2013
Baltimore, MD in conjunction with Johns Hopkins Schl of Nursing & the SoCRA Prep & Review Ccurse Johns Hopkins University School of Nursing
6/28/2013
9 AM to 1 PM
8/16/2013
Charlotte, NC in conjunction with Levine Cancer Institute Clinical Trials Morehead Medical Plaza 5th flr
7/5/2013
8 AM to Noon
9/11/2013
San Francisco, CA in conjunction with UC San Francisco and SoCRA's Prep & Review Course Smith Cardiovascular Research Institute
7/31/2013
9 AM - 1 PM
9/14/2013
Plymouth, MN in conjunction with St. Jude Medical, Inc. St. Jude Medical, Inc.
8/2/2013
9 AM to 1 PM
9/20/2013
St. Louis, MO in conjunction with Washington University School of Medicine/Siteman Cancer Center Center for Outpatient Health
8/9/2013
8 AM to Noon
9/21/2013
Raleigh, NC in conjunction with Duke Cancer Center Raleigh Duke Raleigh Cancer Center
8/9/2013
8 AM to Noon
9/26/2013
New Orleans, LA in conjunction with SoCRA's Annual Conference
and Prep & Review Course
Sheraton New Orleans Hotel
8/13/2013
8 AM to Noon
9/28/2013
Indianapolis, IN in conjunction with Indiana U School of Med, Dept of Peds, Section Adolescent Med Health Information & Translational Sci Buiilding
8/17/2013
8 AM to Noon
10/5/2013
Hackensack, NJ in conjunction with Hackensack Medical Center & SoCRA's Prep & Review Course John Theurer Cancer Center
8/24/2013
8 AM to Noon
10/8/2013
Nashville, TN in conjunction with Sarah Cannon Research Institute Hospital Corporation of America (HCA)
8/27/2013
9 AM to 1 PM
10/9/2013
Dallas, TX in conjunction with COG (Children's Oncology Group) TBD
8/28/2013
8 AM to Noon
10/12/2013
Philadelphia, PA in conjunction with the SoCRA Monitoring Workshop Sheraton City Center Hotel
8/29/2013
8 AM to Noon
10/16/2013
Las Vegas, NV in conjunction with SoCRA's Clinical Science
Course and the Project Management Worshop
Bally's Las Vegas
9/4/2013
5:30 PM to 9:30 PM
10/18/2013
Edmonton, AB Canada in conjunction with Clinical Trials Unit Cross Cancer Institute Cross Cancer Institute
9/6/2013
8 AM to Noon
10/19/2013
Cincinnati, OH in conjunction with Cincinnati Children's Hospital Medical Center Sabin Auditorium
9/6/2013
8 AM to Noon
10/23/2013
Rochester, MN in conjunction with Mayo Clinic Office of
Research Education
Mayo Clinic Siebens Building
9/11/2013
8 AM to Noon
10/24/2013
Memphis, TN in conjunction with St Jude Children's Research
Hospital
St Jude Board Room
9/3/2013
8:30 AM to 12:30 PM
10/26/2013
Cleveland, OH in conjunction with the Cleveland Clinic Lerner Research Dining Commons
9/14/2013
8 AM to Noon
10/29/2013
Los Angeles, CA in conjunction with Cedars Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute Davis Building
9/17/2013
8 AM to Noon
10/30/2013
Troy, MI in conjunction with Beaumont Hospitals Research Institute National City Building
9/18/2013
8 AM to Noon
11/1/2013
Sacramento, CA in conjunction with UC Davis Clinical & Translational Science Center CTSC Auditorium
9/20/2013
1 PM to 5 PM
11/2/2013
Houston, TX in conjunction with the SoCRA Houston Chapter The Methodist Hospital
9/20/2013
9 AM to 1 PM
11/7/2013
Rosemont, IL in conjunction with Alliance for Clinical Trials in Oncology
Intercontinental Hotel Chicago O'Hare
9/26/2013
9 AM to 1 PM
11/8/2013
Atlanta, GA in conjunction with SoCRA's FDA Workshop JW Marriott Hotel
9/27/2013
8 AM to Noon
11/15/2013
Kansas City, KS in conjunction with University of Kansas Medical Center Research Institute University of Kansas Medical Center
10/4/2013
8:30 AM to 12:30 PM
11/16/2013
Orlanda, FL in conjunction with SoCRA's Site Management
Workshop
Marriott's World Center Hotel
10/6/2013
8 AM to Noon
11/23/2013
Indianapolis, IN in conjunction with Indiana U School of Med, Dept of Peds, Section Adolescent Med Health Information & Translational Sci Building
10/12/2013
8 AM to Noon
12/7/2013
Tampa, FL in conjunction with SoCRA's Clinical Investigator and
Research Staff Workshop
Marriott Tampa Waterside Hotel
10/26/2013
8 AM to Noon
12/14/2013
San Diego, CA in conjunction with SoCRA's Finance & Productivity Workshop Westin San Diego Hotel
11/8/2013
8 AM to Noon

The Examination Schedule is available in Adobe PDF format, which can be viewed using the free-download of Adobe Acrobat Reader. (Click Here to Download this FREE software)

Click Here to view/print the Examination Schedule in Adobe PDF Format.

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