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Clinical Research Professional Certification & Preparing for the

CCRP Exam

Signe Denmark, MS, CCRPToni Mauney, CCRP


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SoCRA: Society of Clinical Research Associates

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 health care research community.

Individuals approved may use the title of “Certified Clinical Research Professional” or “C.C.R.P”


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Upcoming SoCRA Certification Exam

Date: Saturday, September 20, 2014Place: MUSC, ART Auditorium Time: 9AM‐1PMCost: $195

www.socra.org

Registration deadline for the MUSC exam is: August 8, 2014


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Who is eligible for SoCRA Certification?

The applicant must meet one of the following criteria:• 2 years of experience as a full‐time Clinical Research Professional

(or have 3,500 hours part‐time) during the last five years OR• Associate’s or Bachelor’s Degree in Clinical Research AND have 1

year of full‐time experience (or 1750 part‐time hours) during the last two years in an area of clinical research OR

• Certificate of Completion from an Undergraduate or Graduate Clinical Research curriculum of no less than 12 semester (credit) hours at an academically accredited institution of higher learning (community college, college or university) AND hold an Associate’s or Bachelor’s Degree in science, health science, pharmacy or related field PLUS have 1 year of full‐time experience (or 1750 hours part time) during the past 2 years in an area of clinical research.


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Why Should I Obtain Certification?

• Acknowledgement of your expertise

• Competitive edge in vying for innovative clinical trials

• Professional networking and development


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About the Certification Exam

• The certification examination is made up of five major subject areas

• There are 135 questions• 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


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Five Subject Areas of the Exam

Percent of Scored Test Items in Each Area• Ethical Principles / Informed Consent / Safety = 20% ‐

25%• Institutional Review Board / Institutional Ethics

Committee (IRB/IEC) Roles and Responsibilities = 7% ‐11%

• Clinical Trial Protocol and Protocol Amendments = 4% ‐8%

• Investigator Roles and Responsibilities = 28% ‐ 32%• Sponsor Roles and Responsibilities = 31% ‐ 35%


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Ethical Principles/ Informed Consent/Safety(20% ‐ 25%)

• Nuremberg Code• Belmont Report• Declaration of Helsinki• Informed consent including development, content, review, approval,

discussion, documentation and ongoing updates• Maintenance of informed consent documents (paper/electronic)• Abstracting/verification of information from medical records related to

informed consent and safety reporting• Vulnerable subjects• Safety Reporting (adverse events, serious adverse drug experiences,

unanticipated adverse device effects)• Financial disclosure


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Institutional Review Board/ Institutional Ethics Committee (IRB/IEC) Roles and Responsibilities

(7% ‐ 11%)• Roles and Responsibilities roles, etc. of IRB/IEC• Determination that the rights, welfare and safety of study subjects

including vulnerable populations are protected• Development and implementation of Standard Operating Procedures

(SOPs)• Membership• Significant Risk/Non Significant Medical Device study determination• Documentation• Record retention IRB/IEC


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Clinical Trial Protocol and Protocol Amendments (4% ‐ 8%)

• Protocol development (including study design with considerations methods to reduce bias, objectives, endpoints, data safety monitoring)

• Protocol Amendments


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Investigator’s Roles and Responsibilities(28% ‐ 32%)

• Roles, responsibilities and obligations of the investigator• Study conduct in accordance with investigational plan, investigator agreement

and applicable regulations• Protocol(s) and protocol related document(s) (i.e., informed consent documents,

recruitment materials, safety reports, continuing reviews) development, review, and submission for reviewing authorities

• Recruitment, screening, enrollment, and retention of subjects• Investigational site source documentation• Documentation/Reporting discontinuation study subjects• Investigational site study related reports (i.e. progress reports, protocol changes,

protocol deviations, final reports)• Source Documentation/Case Report Forms• Maintenance of essential study related documents (paper/electronic)• Abstracting/verification of Information from Medical Records• Record retention requirements for clinical sites


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Sponsor’s Roles and Responsibilities(31% ‐ 35%)

• Investigator/site qualification• Investigational site training, management, oversight and investigator

compliance (including GCP, investigational product, study and reporting requirements)

• Protocol and protocol related documents• Sponsor investigational product accountability • Standard operating procedures• Regulatory documents (FDA Forms 1571, 1572, 3454, 3455, IND, IDE,

Medwatch (3500 and 3500A))• Study plan• Development, verification, maintenance of electronic records and electronic

record systems• Maintenance of essential study related documents (paper/electronic)


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Exam Structure

• 135 multiple choice and true/false questions• Case Studies: The examination will contain 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. Case studies may involve questions regarding scheduling, dose modifications and reading medical and clinical reports.


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SoCRA Exam Preparation

Utilize the materials provided and review your study guide. The Certification Program Reference Manual includes:• 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)

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.


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SoCRA Exam Preparation Tips

• Don’t get overwhelmed by the amount of text in the regulations. Pull out the key points and organize your thoughts.

• Be confident. Over your time in research, you know a lot more than you think.

• Test smart. Don’t get stuck on questions. Don’t overanalyze. Put a place holder on your answer sheet, move on and come back to a difficult question later.

• Patient safety first. When in doubt, go for the answer that offers the best protection to the subject’s rights and welfare.


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SoCRA Study Sessions

Thursday, 8/14, 11:30AM ‐12:30PM – Ethical Principles, Informed Consent, Research Nexus Conference Room CSB 214A Safety

Wednesday, 8/20, 12:00PM ‐1:00PM – IRB/IEC Roles and Responsibilities Research Nexus Conference Room CSB 214A

Thursday, 8/28, 11:30AM‐12:30PM – Clinical Trial Protocol and Protocol Research Nexus Conference Room CSB 214A Amendments

Wednesday, 9/3, 12:00PM‐1:00PM – Investigator’s Roles and Research Nexus Conference Room CSB 214A Responsibilities

Thursday, 9/11, 11:30PM‐12:30PM – Sponsor’s Roles and Research Nexus Conference Room CSB 214A Responsibilities

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