Socra Exam Prep 1g6q6r
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SLIDE HEADING
Clinical Research Professional Certification & Preparing for the CCRP Exam Signe Denmark, MS, CCRP Toni Mauney, CCRP
843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
SLIDE HEADING 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” 843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
SLIDE HEADING SoCRA Certification Exam
Date: Saturday, September 20, 2014 Place: MUSC, ART Auditorium Time: 9AM‐1PM Cost: $195 www.socra.org
Registration deadline for the MUSC exam is: August 8, 2014
843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
SLIDE HEADING 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.
843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
SLIDE HEADING Why Should I Obtain Certification?
• Acknowledgement of your expertise • Competitive edge in vying for innovative clinical trials • Professional networking and development
843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
SLIDE HEADING About the Certification Exam
•
• •
•
843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
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
SLIDE HEADING 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% 843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
SLIDE HEADING Five Subject Areas of the Exam
• • • • • • • • •
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
843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
SLIDE HEADING Five Subject Areas of the Exam
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) hip Significant Risk/Non Significant Medical Device study determination Documentation Record retention IRB/IEC
843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
SLIDE HEADING Five Subject Areas of the Exam
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
843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
SLIDE HEADING Five Subject Areas of the Exam
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
843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
SLIDE HEADING Five Subject Areas of the Exam
Sponsor’s Roles and Responsibilities (31% ‐ 35%) • • • • • • • • •
Investigator/site qualification Investigational site training, management, oversight and investigator compliance (including G, investigational product, study and reporting requirements) Protocol and protocol related documents Sponsor investigational product ability 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)
843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
SLIDE HEADING 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.
843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
SLIDE HEADING 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 G 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.
843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
SLIDE HEADING 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.
843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
SLIDE HEADING 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 843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
Clinical Research Professional Certification & Preparing for the CCRP Exam Signe Denmark, MS, CCRP Toni Mauney, CCRP
843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
SLIDE HEADING 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” 843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
SLIDE HEADING SoCRA Certification Exam
Date: Saturday, September 20, 2014 Place: MUSC, ART Auditorium Time: 9AM‐1PM Cost: $195 www.socra.org
Registration deadline for the MUSC exam is: August 8, 2014
843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
SLIDE HEADING 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.
843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
SLIDE HEADING Why Should I Obtain Certification?
• Acknowledgement of your expertise • Competitive edge in vying for innovative clinical trials • Professional networking and development
843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
SLIDE HEADING About the Certification Exam
•
• •
•
843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
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
SLIDE HEADING 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% 843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
SLIDE HEADING Five Subject Areas of the Exam
• • • • • • • • •
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
843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
SLIDE HEADING Five Subject Areas of the Exam
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) hip Significant Risk/Non Significant Medical Device study determination Documentation Record retention IRB/IEC
843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
SLIDE HEADING Five Subject Areas of the Exam
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
843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
SLIDE HEADING Five Subject Areas of the Exam
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
843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
SLIDE HEADING Five Subject Areas of the Exam
Sponsor’s Roles and Responsibilities (31% ‐ 35%) • • • • • • • • •
Investigator/site qualification Investigational site training, management, oversight and investigator compliance (including G, investigational product, study and reporting requirements) Protocol and protocol related documents Sponsor investigational product ability 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)
843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
SLIDE HEADING 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.
843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
SLIDE HEADING 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 G 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.
843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
SLIDE HEADING 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.
843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
SLIDE HEADING 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 843‐792‐8300 843‐792‐8300
sctr.musc.edu sctr.musc.edu
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