Enhanced Monitoring Tools and Strategies that Optimize Productivity and Compliance

Date: Sept. 15, 2010 Time: 12:00 pm - 1:30 pm Eastern Time US; Please check your time zone prior to the webinar Registration Deadline: Sept. 14, 2010, 11:59 pm Eastern Time  Contact Hours: CBRN, ACRP Earn 1.5 contact hours (only purchaser eligible to receive contact hours) Level: Intermediate Member Rate: $99.00 Regular Rate: $124.00

Program Description
Clinical Monitoring represents a crucial aspect of clinical research trials in ensuring subject safety, data integrity, and proper trial conduct in Good Clinical Practice (GCP) compliance and other regulations. This presentation will:

• Discuss the issues surrounding monitoring performance in US-based pre-market studies and provide enhanced techniques that optimize productivity without compromising subject safety and quality data.
• Review techniques that supersede basic training and enhance clinical monitoring efficiency in US- based premarket trials.

Target Audience
This webinar is intended for Clinical Research Associates, Senior Clinical Research Associates, Clinical Research Coordinators, and Clinical Research Administrators.

Learning Objectives
Upon completion of this webinar, attendees should be able to:

• Identify the concerns surrounding current monitoring practices and performance
• Infer how monitoring performance is perceived based on audit findings noted among clinical sites and sponsor companies
• Discuss monitoring strategies and tools that will enhance basic monitoring techniques and optimize productivity at site visits

Presenter
Kimberly Kiner, BSc., CCRA, is the President of 2K Clinical Consulting, Inc. a niche provider that focuses on simplifying trial management by providing monitoring and co-monitoring services to sponsor companies, CROs and sponsor-investigators. She has 13+ years of diverse experience in the regulatory field as a prior FDA investigator and in the clinical research industry as a CRA, Lead CRA and Independent Consultant with CRO and sponsor companies. Mrs. Kiner has experience in therapeutic areas of Cardiovascular, CNS, Medical devices/In Vitro Diagnostics, Infectious Diseases, Gastroenterology, Endocrinology and Women’s Health.

Disclosure Statement
Ms. Kiner states that she has no actual or potential financial conflict of interest in relation to this program.

Accreditation Information

Continuing Nursing Education

The California Board of Registered Nursing approves the Association of Clinical Research Professionals (ACRP) as a provider of continuing nursing education. ACRP’s webinar program provides 1.5 contact hours of continuing Nursing education credit (Program Number 11147-2010-317).

Association of Clinical Research Professionals

The Association of Clinical Research Professionals (ACRP) provides 1.5 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-2010-WEB-317).

Please note: Webinar presentations are delivered online at the scheduled presentation time only and will not be distributed prior to or following the event. Speakers maintain all copyrights on presentation materials and duplication or preservation of webinar content is strictly prohibited.