1. MODULE A:MODULE A: Introduction to the CRA/CRC RolesIntroduction to the CRA/CRC Roles Jane FendlJane Fendl March 24, 2010March 24, 2010 1Version: 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 2Version: 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 3Version: 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  14 APR 2010  17 APR 2010  21 APR 2010  24 APR 2010  01 May 2010 4Version: 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 5Version: 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 6Version: 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.orgwww.acrpnet.org 7Version: 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 collection tools, source data).  Solicitation of adverse events from research site staff for reporting to the sponsor. www.acrpnet.org 8Version: Final 24-Mar-2010

9.  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 CRA Roles and Responsibilities con’t 9Version: 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 10Version: 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. 11Version: 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 12Version: Final 24-Mar-2010

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

14. CRC/CRA Tasks CRCCRA Completes regulatory documents for submission to sponsor Reviews regulatory documents to ensure accuracy & completion Maintains sponsor's study filesReviews accuracy & completeness of site files Prepares site for monitoring visitsConducts monitoring visits Recruits & screens patients for studyReviews eligibility & recruitment efforts Maintains & dispenses drug suppliesReviews accuracy of drug accountability & insures return/destruction Completes & insures quality of CRFs Maintains source documents Verifies that the data in the CRF is in agreement with the source documents Ensures site quality is maintained by following the protocol, “Good Clinical Practices” and regulatory requirements Ensures that the site personnel is conducting the study in accordance with the protocol & “Good Clinical Practices”, and regulatory requirements 14Version: 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) 15Version: Final 24-Mar-2010

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

17. 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) Qualifications for Employment & Certification 17Version: Final 24-Mar-2010

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

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