Fundamentals of Clinical Research - San Francisco
| Date: Thursday, June 21 and Friday, June 22, 2012 |
| Time: 8:00 am – 5:00 pm each day |
| Advance Registration Deadline: Thursday, June 14, 2012 |
| Registration with $150 late fee until Thursday, June 21, 2012 (if space is available) |
| Registration is limited to 35 attendees |
| Contact Hours: Earn 14.0 ACRP, CBRN, or ACCME contact hours |
| Level: Basic |
| Member Rate: $990.00 |
| Regular Rate: $1,170.00 |
| Location: Hyatt Fisherman’s Wharf, 555 North Point St., San Francisco, CA 94133; Phone: 415-563-1234 |
ACRP’s special hotel block has sold out.
Please call Cathy Chan with Hyatt Fisherman’s Wharf at (415) 486-4417, and mention you are attending the ACRP Fundamentals of Clinical Research class. Room reservations are based on hotel availability.
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Course Description
This two-day course, revised in 2011, provides the core knowledge and practical insight that clinical research professionals need in order to execute their functions more effectively and efficiently. The topics covered include an introduction to clinical research, ethical concerns and human subject protection, regulatory obligations, essential documents including research records, clinical trials start up and conduct, quality control focusing on the monitoring of clinical trials, adverse experiences, and subject recruitment. The course includes a Participants’ Manual, PowerPoint presentations, interactive classroom exercises, and question‐and‐answer sessions.
Who Will Benefit
This course is aimed at clinical research professionals with up to 18 months of practical experience in clinical trials, although those with more experience may also find the course to be a useful update. “Fundamentals of Clinical Research” is designed for clinical research associates (CRAs), clinical research coordinators (CRCs), principal investigators (PIs), project managers, institutional review board members, and pharmacists who manage or monitor drug, device, or biologics studies at clinical research sites, as well as other professionals working for pharmaceutical or device firms, contract research organizations, and related vendor services.
What You Will Learn
Upon successful completion of this course, participants should be able to:
- Discuss the main historical events which led to the increasing regulation of the development of pharmaceutical products, devices, and biologics
- Explain the differences in the development processes for pharmaceutical products, devices and biologics
- Identify the roles and responsibilities of clinical research professionals in the overall process of conducting a clinical trial and how each professional contributes to that process
- Apply the principles of Good Clinical Practice (GCP) in their daily functions
- Identify the main regulations which govern the practice of clinical research
Trainers
ACRP only uses experienced, proven trainers. In certain cases, instructors may be substituted depending on availability. Please view the details for each event and full trainer information.
Course Reviser
Jill Matzat, RN, BSN, CCRA®, CCRT was the 2011 Course Reviser and is President and CEO of Medical Research Management, Inc.
Jill discloses that she is the owner of Medical Research Management, Inc., a Clinical Research Training Company, and CRA Solutions, a Contract Research Organization.
Course Reviewers
Jennifer Holcomb, MA, CCRA®, is Director of the Clinical Research Support Office at Duke University. She also serves as Vice-Chair of the ACRP Professional Development Committee.
Jennifer has no relevant financial relationships in connection with this educational activity.
Nina Trocky, DNP, RN, PhD, NE-BC, CCRA®, is Assistant Professor/Program Director at the University of Maryland School of Nursing. She also serves as a member of the ACRP Professional Development Committee.
Nina has no relevant financial relationships in connection with this educational activity.
Deidra Poucher, RN, MSHS, CCRC®, is Principal, D. Poucher Consulting, LLC. She also serves as a member of the ACRP Professional Development Committee.
Deidra discloses that she is an employee of D. Poucher Consulting, LLC, and the George Washington University.
Click here to view ACRP’s Disclosure Statement.
Accreditation Info
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Association of Clinical Research Professionals
The Association of Clinical Research Professionals (ACRP) provides 14.0 continuing education credits for the completion of this educational activity with the completion of the online evaluation form. These credits can be used to meet the certification maintenance requirement (Program Number ACRP-2011-SEM-500).
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Continuing Nursing Education
The California Board of Registered Nursing approves the Association of Clinical Research Professionals (ACRP) as a provider of continuing nursing education. This live classroom course provides 14.0 contact hours of continuing nursing education credit (Program Number 11147-2011-SEM-500).
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Accreditation Council for Continuing Medical Education
Accreditation Statement
The Association of Clinical Research Professionals (ACRP) is accredited by the Accreditation Council for Continuing Medical Education to provide Continuing Medical Education for physicians.
The Association of Clinical Research Professionals designates this live activity for a maximum of 14 AMA PRA Category 1 credits™. Each physician should only claim credit commensurate with the extent of their participation in the activity.
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Continuing education credits (contact hours) are awarded with the completion of an online evaluation form, which must be completed within 30 days after the course has occurred. Upon submission of the evaluation form, a link to the printable certificate will be made available on the attendee’s ACRP personal page.
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