MODULE A : Introduction to the CRA/CRC Roles Jane Fendl March 24, 2010

1. MODULE A: Introduction to the CRA/CRC Roles Jane Fendl March 24, 2010 Version: Final 24-Mar-2010

2. Clinical Research Associate (CRA)/Clinical Research Coordinator (CRC) • Introductions and contact information • Jane Fendl – 732-688-3974 • Denise Thwing – 908-489-7230 • Pat Koziol – 732-471-0475 • Class Introductions • Housekeeping • Course Objectives • Course Modules, class dates and times • Class Requirements Version: Final 24-Mar-2010

3. COURSE OBJECTIVES • Understand the role of the CRA and CRC • Know the purpose of a clinical trial • Become familiar with a clinical protocol • Become familiar with the regulations and regulatory documents as they relate to monitoring and coordinating clinical trials • Select a Clinical Investigator based on specified criteria and understand their role • Understand the importance and how to conduct the standard monitoring visits: • Pre-study • Initiation • Interim • Including data management process relating to monitoring • Close-Out • Learn the role of the CRA/CRC in Audits and Inspections Version: Final 24-Mar-2010

4. COURSE MODULES • MODULE A: Introduction to the CRA/CRC roles • MODULE B: Overview of the Clinical Trial & Protocol • MODULE C: Regulations and Regulatory Documents • MODULE D: Basic Principles of Privacy • MODULE E: Investigator Qualification and Site Selection • MODULE F: Pre-Study Assessment Visit • MODULE G:Initiation Visit • MODULE H: Interim Monitoring Visit • MODULE I: Close-Out Visit • MODULE J:Audits and Inspections • 24 MAR 2010 • 31 MAR 2010 & 07 APR 2010 • 10 APR 2010 • 10 APR 2010 • 14 APR 2010 • 17 APR 2010 • 17 APR 2010 • 21 APR 2010 • 24 APR 2010 • 01 May 2010 Version: Final 24-Mar-2010

5. COURSE REQUIREMENTS • 80%Attendance required for a passing grade TOTAL HOURS = 36 X .8 = 29 hours • 20%Attendance/Class Participation • 30%Test/Quizzes • 50% • 2 Projects • Develop a Clinical Monitoring Plan • Write and review a Monitoring Trip Report Version: Final 24-Mar-2010

6. MODULE A • Introduction to the CRA/CRC roles • Functional roles of CRAs and CRCs • Interaction between CRAs and /CRCs • Qualifications for employment and certification Version: Final 24-Mar-2010

7. CLINICAL RESEARCH ASSOCIATE • A CRA is a professional who, regardless of job title, monitors the administration and progress of a clinical trial on behalf of a sponsor whether from a field monitoring or in-house monitoring perspective. Major responsibilities include: • Communicate – main line of communication between sponsor and Investigator • Confirm- verify that the Investigator is following GCP and the protocol • Counsel – counsel the Investigator regarding protocol, deviations, GCPs, SOPs regulatory requirements , educate staff and be a resource • Corroborate – verify accuracy and completeness of the CRF entries, source documents and other study related records. • Associate of Clinical Research Professionals www.acrpnet.org Version: Final 24-Mar-2010

8. CRA Roles and Responsibilities con’t • Assurance that the research site personnel including the investigators is conducting the study according to the clinical protocol, "Good Clinical Practices," and regulatory requirements. • Verify that the data in the CRFs are in agreement with the source documents (source data verification). • Review accuracy and completeness of site records (site study file, CRFs and other data collectiontools, source data). • Solicitation of adverse events from research site staff for reporting to the sponsor. www.acrpnet.org Version: Final 24-Mar-2010

9. CRA Roles and Responsibilities con’t • Review accuracy of drug accountability. • Other clinical trial related activities for the sponsor such as protocol development, site/investigator selection, study initiation activities, study termination activities, CRF processing/management activities (including in-house sponsor review and query resolution), final study report development, and supervision of other CRAs. • Maintenance of the sponsor's study files including all essential documents. • Complete reporting of all these activities (e.g. visit reports, trial management tracking system). www.acrpnet.org Version: Final 24-Mar-2010

10. CRA Challenges • Scheduling monitoring visits with the sites • Airline and hotel accommodations within budget • Monitoring space • Investigator availability • Time to review data for accuracy/review sDCF for accuracy and resolution • Diary compliance • Initial and ongoing assessment lab/clinical data • Change from baseline/causes • Abnormal values/why? • Ensure subject compliance with protocol/deviations • Multiple protocols • Site communication Version: Final 24-Mar-2010

11. CRA IDEAL CHARACTERISTICS • Graduates with a degree in life and medical sciences. • Recommended classes: • biochemistry; • anatomy; • biology; • biomedical science; • chemistry; • dentistry; • microbiology; • medicine; • nursing; • immunology; • molecular biology; • toxicology; • physiology; • pharmacology; • pharmacy. Version: Final 24-Mar-2010

12. CRA IDEAL CHARACTERISTICS con’t • Interest in research • Out-going personality and good people skills • Attention to detail • Self-motivated and independent personality • Organized with the ability to multi-task • Good communication skills • Ability to travel 50%-80% of the time unless based in-house Version: Final 24-Mar-2010

13. Break for 15 minutes Return for CRC presentation Version: Final 24-Mar-2010

14. CRC/CRATasks Version: Final 24-Mar-2010

15. Qualifications for Employment & Certification CRA • Option 1 - Education: Bachelor's degree or RN • Working Experience as a CRA: 2 years full-time, or 4 years part-time, or • Option 2 - Education: Associate's degree • Working Experience as a CRA: 3 years full-time, or 6 years part-time, or • Option 3 - Education: Other (e.g., LPN, LVN, Medical Assistant, H.S. diploma) • Working Experience as a CRA: 4 years full-time, or 8 years part-time, or • Option 4+ - NEW! - Education: Option 1, 2 or 3 and the completion of a one-year education program in Clinical Research from an accredited institution will reduce the working experience by 1 year • Work Experience as a CRA: See Chart at top of next page. (Note: A minimum of 37.5 hours per week qualifies as full-time employment, and a minimum of 20 hours per week qualifies as part-time employment) Version: Final 24-Mar-2010

16. Qualifications for Employment & Certification CRA Con’t Version: Final 24-Mar-2010

17. Qualifications for Employment & Certification CRC • Option 1 - Education: Associate/Bachelor's degree or RN • Working Experience as a CRC: 2 years full-time, or 4 years part-time, or • Option 2 - Education: Other (e.g., LPN, LVN, Medical Assistant, Lab Technician, H.S. diploma) • Working Experience as a CRC: 3 years full-time, or 6 years part-time, or • Option 3+ - NEW-Education: Option 1 or 2 and the completion of a one-year educational program in clinical research from an accredited institution • Working Experience as a CRC: See Chart on next page • Option 3+ requires additional information to be listed on the CV (see Appendix 1 for Sample CV) and the submission of a certificate of completion. (Note: A minimum of 37.5 hours per week qualifies as full-time employment, and a minimum of 20 hours per week qualifies as part-time employment) Version: Final 24-Mar-2010

18. Qualifications for Employment & Certification CRC Con’t Version: Final 24-Mar-2010

19. 31 Mar 2010 & 07 Apr 2010 MODULE B: Overview of the Clinical Trial & Protocol Version: Final 24-Mar-2010