Description & Objectives

Description & Objectives

Intended Audience

This symposium is intended for all physicians and health-care professionals, in any specialty, who are interested in expanding their clinical research knowledge and skills.

Needs Statement

There is a gap in knowledge of best-practice methods for conducting clinical trials, which leads to potential compliance issues as investigators accept full responsibility for overseeing their clinical trials. Clinical trial training is an essential part of developing a vibrant research program.

In addition to addressing the existing gap in clinical research knowledge, this course will incorporate an educational component related to initiating new research through Swedish's relatively new membership in the NeuroNEXT consortium. 

Course Objectives

At the conclusion of this symposium, the participant will have an increased ability to:

  • Discuss rationale and strategies for development of drugs and devices for human treatment
  • Examine the role of research in a clinical program and discuss the challenges of overseeing research
  • Identify ways to obtain and document information in a manner that meets FDA requirements
  • Outline what an IRB review consists of and how to submit a protocol
  • Navigate the relationship between sponsors, sites and CROs, the components of a clinical study protocol and their importance in research, as well as describe the difference between clinical research, patient care and QA
  • Describe what a Data Safety Monitoring Committee (DSMC) does, how the DSMC interacts with other study oversight groups, the basic statistical considerations for a clinical trial, what a serious adverse event (SAE) is and how an investigator should handle a SAE
  • Review pertinent clinical research regulations and investigator responsibilities

 Online registration is now closed.
Walk-in registration will be available on the day of the conference.

Date:
Friday, March 15, 2013
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Time:
7:30 a.m.-4:15 p.m.

Location:
Swedish Education &
Conference Center
Swedish/Cherry Hill

 

Swedish Medical Center is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.