Certification

Certification Declares Professionalism and Expertise!

Overview

The Society of Clinical Research Associates proudly announces their Certification Program for Clinical Research Professionals. This web page contains information concerning this program, and certification application instructions. Applicants are those individuals with two or more years’ experience in clinical research. Individuals meeting all of the eligibility and application requirements will be required to successfully complete a written examination.

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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 clinical research field. Much of our training has come after our employment as a Clinical Research Professional. Every institution and discipline have unique requirements.

The examination must be based on those areas that are common to all Clinical Research Professionals. It must, out of necessity, be a basic examination. Questions are formulated to be straight -forward and easily understood.

Items on the examination outline that you deal with on a daily basis should not require extensive study on your part; it is anticipated that this is part of your working knowledge. Areas of the outline 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, 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 want to study the United States Federal Regulations concerning trials. (Most of these regulations cross national borders; however, this examination will relate specifically to United States federal regulations.)

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Scope

SoCRA established the Certification Program for Clinical Research Professionals in order to create an internationally accepted level of knowledge, education, and experience by which clinical research professionals will be recognized by the medical research community.

Those individuals so approved may use the title "Certified Clinical Research Professional" or "C.C.R.P. (SoCRA)".

A Clinical Research Professional may serve as a clinical investigator, sub-investigator, clinical researcher, research nurse, administrator, coordinator, data manager, project manager, IRB coordinator, Quality Assurance specialist, regulatory affairs specialist, research pharmacist, consultant, or educator in clinical trials management. A Clinical Research Professional is involved in one or more aspects of clinical trials (GCP) research, including data collection, analysis, or monitoring; case management of protocol participants; recruitment and enrollment of human subjects; protection of subjects and subjects’ rights through IRB relations; development of informed consent documents; preparation of adverse event experience reports; construction or monitoring of case report forms; maintenance of drug accountability records; grant and budget development; report preparation; education of other health-care professionals, patients or families regarding clinical trials, protocol development, program administration; and research program audit.

The certification examination has been developed by SoCRA's Certification Committee and designated members who have demonstrated expertise in the development, management, and administration of clinical trials. Test questions have been written by Clinical Research Professionals from diverse backgrounds and job descriptions. The examination is intended to evaluate the applicant's knowledge and skill in comparison to the demands on a Clinical Research Professional as they are found in clinical practice. 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 Certification Examination. The competencies and the approximate percentages of the examination questions that address those concepts are the following:

• Identify and differentiate the foundations and principles of clinical research ethics.
  5%
• Demonstrate knowledge of laws, regulations, guidance, and standard operating procedures and their application to regulated clinical research.
  20%
• Distinguish and define the responsibilities of sponsors, monitors, and investigators according to the principles of the International Conference of Harmonisation, Good Clinical Practice (ICH/GCP) and the Code of Federal Regulations (CFR).
  15%
• Identify and apply the regulations and guidance as they relate to informed consent, IRB/IECs, and financial disclosure.
  15%
• Identify the principles of study design, study closure, and record retention.
  15%
• Demonstrate knowledge and application of safety reporting requirements.
  5%
• Demonstrate the ability to utilize critical thinking skills in practical applications.
  25%

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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 application of approved clinical research regulations and approved clinical research guidelines. 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
• FDA Information Sheets for Clinical Investigators
• ICH GCP Guideline for Good Clinical Practice (E6), and
• ICH Clinical Safety Data Management: Definitions and Standards for Expedited Reporting

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Applicants Who Have Special Needs

Applicants having special needs should contact the SoCRA office to discuss testing requirements for persons with physical, sensory or learning disabilities.

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Eligibility

• In order to be considered for SoCRA certification, the applicant must be a current member of SoCRA working with GCP guidelines under IRB/EC/REB approved (or specifically exempted) protocols.
• SoCRA will not be able to consider candidates who are unable to provide the requested supporting documentation regarding their experience in clinical research.
• Any questions regarding the eligibility requirements should be directed to the SoCRA Administrative Office.

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.

ELIGIBILITY CATEGORIES – The applicant’s experience must fall under one of the following categories:

Category 1: Candidates having completed a minimum of 2 years of full time employment (or 3500 hours of part-time employment) during the past five years as a clinical research professional.

Category 2: Candidates holding a degree in “Clinical Research” from an Associate, Undergraduate or Graduate Degree Program AND having 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.

Category 3: Candidates holding 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 holding an Associate’s or Bachelor’s Degree in a science, health science, pharmacy or related field AND having 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.

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Definition of a Clinical Research Professional

A Clinical Research Professional functions as a clinical investigator, sub-investigator, clinical researcher, research nurse, administrator, coordinator, consultant, or educator in clinical trial management. A Clinical Research Professional is involved in one or more aspects of clinical trials (GCP) research, including data collection, analysis, or monitoring; case management of protocol participants; recruitment and enrollment of human subjects; protection of subjects and subjects’ rights through IRB relations; development of informed consents; preparation of adverse event experience reports; construction or monitoring of case report forms; maintenance of drug accountability records; grant and budget development; report preparation; education of other health-care professionals, patients or families regarding clinical trials, protocol development, program administration; and research program audit.

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Examination Content

The certification examination is made up of five major subject areas, which are listed on the examination outline. Each major area will be included in each examination, but specific questions will vary from one examination date to another. The percentage of questions from each area will change slightly from one examination to another, with each question equivalent in weight. This examination will be revised at least annually, following a review by the Certification Committee.

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Term of Certification

The CCRP (SoCRA) is awarded for three years to continuing members of SoCRA. Renewal after three years requires 45 hours of validated continuing education credit, completion of a re-certification quiz, a re-certification fee (which at this time is $100), and consecutive years' membership in SoCRA.

Falsification or misrepresentation of application information will invalidate the applicant's certification.

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Examination Development

The certification examination has been developed by SoCRA's Certification Committee and designated members who have demonstrated expertise in the development, management, and administration of clinical trials. Test questions have been written by Clinical Research Professionals from diverse backgrounds and job descriptions. The examination is intended to evaluate the applicant's level of knowledge and skill in comparison to the demands on a Clinical Research Professional as they are found in clinical practice.

Unlike many certifying organizations in the health-care field, SoCRA's membership is made up of individuals with a wide variety of backgrounds and job descriptions. Much of the training required of a Clinical Research Professional is specific to the institution and discipline in which they are employed. It would be impossible to develop one examination that would measure a level of expertise for each specific area in the health-care field. 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.

The world of clinical research is a constantly changing work environment for the Clinical Research Professional. For that reason, the Certification Program and the certification examinations will be a continually evolving project, which will be directed by the needs of the membership. It is anticipated that the certification program will develop "levels" of certification in the near future that will additionally define the term "Certified Clinical Research Professional."

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Examination Outline

Conduct of Clinical Trials

• Sponsors and research bases
• Funding
• Study design, trial phases, blinding
• Protocol development
• Protocol amendments
• Investigational drugs, devices, therapies, and procedures
• Record retention
• Adverse events
• Monitoring and quality assurance
• Informed consent
• Grants and funding
• Forms completion and monitoring
• Audits and site visits

Institutional Review Boards and Regulations

• IRB membership
• Reporting requirements (annual reports, protocol changes, and adverse events)
• Clinical Drug Requests
• Federal Drug Administration statement of Investigator (FDA 1571/1572)
• Investigational drug accountability
• Investigational New Drug, New Drug Application

Ethical Issues

• Element of Informed Consent
• Clinical Fraud
• Disclosure of Clinical Information
• FDA & ICH Guidelines on Research

Ability to Follow Directions

This portion of the examination will ask questions involving test schedules and dose modifications.  There will also be questions directly related to your ability to follow directions.

Abstracting Information from Medical Records

This portion of the examination is a practical examination, including common mathematical calculations, reading clinical reports, and reading medical records.

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Examination Sample Questions

Q1.  Informed consent documents must include the following:

a. A statement that the study involves research.
b. A statement of the possible risks.
c. A discussion of possible alternative treatments.
d. All of the above.

Q2. Responsibility for the participant's safety lies with:

a. The sponsor
b. The investigator
c. The IRB

Q3. Which of the following would require the breaking of a randomization code in a blinded study?

a. The participant withdraws from the study before its conclusion.
b. Participants in only one of the investigating sites show any definite response to treatment.
c. A participant experiences a serious adverse experience, the etiology of which cannot be explained.
d. None of the above.

Q4. The responsibility for ensuring that the investigator Understands a clinical trial lies with:

a. The FDA
b. The IRB
c. The Sponsor
d. None of the above

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Examination Study Guide

SoCRA has a Study Guide to help you prepare for the examination. This guide consists of:

• 21 Code of Federal Regulations – Parts 11, 50, 56, 312, 812
• 45 Code of Federal Regulations- Part 46
• Sample regulatory forms from FDA
• The Nuremberg Code
• The Belmont Report
• Declaration of Helsinki
• Health Canada Information
• FDA Information Sheets for Clinical Investigators
• ICH GCP Guideline for Good Clinical Practice (E6)
• ICH Clinical Safety Data Management: Definitions and Standards for Expedited Reporting

The study guide will be included as part of your package upon registration for the examination. The study guide is also available for purchase at a cost of $50.00 (U.S. Funds).

The Examination Study Guide Purchase Request form 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 Study Guide Purchase Request form in Adobe PDF Format.

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Examination Schedule

2008

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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Certification Application and Fee

The Certification Application 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 Certification Application in Adobe PDF Format.
NOTE: ALL Candidates for SoCRA CCRP Certification must complete and submit the Certification application.

Click here to view/print Form 1011 in Adobe PDF Format.
NOTE: This form 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: This form is required ONLY for candidates applying under Eligibility Category #3.
Please see Eligibility Category #3 for more information.

Certification Application Fee - $195 (U.S. Funds)

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Special Needs

Applicants having special needs should contact the SoCRA office to discuss testing requirements for persons with physical, sensory or learning disabilities.

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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 20 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.

The Certification Exam Schedule Application is available in Microsoft Word format.
To download this form, follow these instructions:

1. Right-click on the link below.
2. Select "Save Target As..."
3. Ensure that the end of the file name ends in .doc
4. Ensure that the "Save as type:" field shows "All Files."
5. Then, click the "Save" button to save this form in the folder shown in the "Save As" dialog box.

Click Here to save the Certification Exam Schedule Request Form to your computer.

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