Chapter News

MN ACRP February 2008 Program on Investigator-Initiated Clinical Trials from a Site Perspective   At MN ACRP’s February 21, 2008 program, clinical research professionals heard Harvey M. Arbit, BS, PharmD, MBA, RPh, RAC, CCRP, Director, IND/IDE Assistance Program, Academic Health Center, University of Minnesota talk about Investigator-Initiated Clinical Trials from a site perspective. This well attended, interactive presentation included Good Clinical Practice (GCP), IND and IDE regulations which site personnel need to know before conducting investigator-Initiated Clinical Trials. At the conclusion of Mr. Arbit’s presentation, participants knew whether or not they should be an IND or IDE sponsor-investigator, understood the regulatory obligations of a sponsor-investigator, and knew what to do if the FDA shows up for an inspection of a investigator-initiated study. It was very apparent that Mr. Arbit is an expert on the topic by the way he fielded several audience questions. Special thanks to Nancy Stinnett, MN ACRP Vice President, and the Minnesota Gastroenterology Corporate Office located in St. Paul for hosting this first 2008 program of the year.

MN ACRP November 2007 Program on Statistics Consideration in Clinical Study Design and Execution On November 15, 2007, the MN ACRP hosted the program, "Statistics Consideration in Clinical Study Design and Execution" at Endovascular, INC. in Plymouth, MN.  The speaker was An Liu, MS.  An is a Principle statistician at Medtronic, Inc. and President of A & L Consulting, LLC.   An used his sense of humor to demonstrate the following statistical considerations: Evidence-based Medicine and RCT, Key statistic concepts (measurement and endpoint, hypothesis testing, p-value, randomization, control group and sample size) and clinical trial design strategy from the perspective of statistics.  The event was well attended and we won’t forget the concept of “Romance is Familiar to Everyone.”

New MN ACRP Officers for 2008

MN ACRP is pleased to announce the following Chapter Officers for 2008 (01/2008): 

• President: Joy L. Frestedt, Ph.D, RAC, CCTI, President and CEO , Frestedt Incorporated
• Vice President/President Elect:  Nancy D. Stinnett, RN, BSN, CCRP, WOCN, Director of Clinical Research, Minnesota Gastroenterology, PA 
• Secretary:  Pamela A. Pawloski, Pharm.D., CCRC , Manager, Research and Tumor Registry
• Treasurer: Andrea Thelen, MA, CCRC, Research Assistant, St. Paul Heart Clinic

MN ACRP also welcomes the following officer and 2008 committee persons:

• Immediate Past President - Lorry Witte
• Programming Co-Chairpersons - Brenda Kirpach and Denise Windenburg
  • Programming Committee Member - LeeAnn Anderson, Lorry Witte, Becky Rorke, Nancy Stinnett
• Hospitality Co-Chairpersons - Chou Eyberg and Alicia Bettman
• Membership Co-Chairpersons - Pamela Wolfe and Karen Hartman Rochester
• Marketing Co-Chairpersons - Mary Prudhomme and Karen Harvey
  • Marketing Committee Member - Julia Pattison-Crisostomo Duluth
• Communication Chairperson - Robin Olson
  • Communication Committee Members - Paul Below, Jennifer Stogny and Lorry Witte

Thanks to all of our members for making our chapter so much fun!

MN ACRP Awarded "Outstanding Chapter" at 2005 ACRP Annual North American Conference
(09/2005) The Minnesota Chapter was awarded the Outstanding Chapter Award at the 2005 ACRP Annual North American Conference & Exposition in Orlando, FL on April 2-6. The following excerpt on the award was published in September 2005 Issue of The Monitor:

"The Outstanding Chapter Award is given to an ACRP chapter that participates in ACRP activities, organizes chapter events, and recruits new members to the chapter. This Chapter is considered instrumental for implementing change at the ACRP association global office level for the improvement of services provided to ACRP chapter members.

The Minnesota Chapter is the 2005 recipient of the Outstanding Chapter Award, and is ACRP’s first repeat winner of this award. Over the past year, the chapter hosted an evening networking event and six evening educational programs on a wide range of topics that attracted a diverse audience commensurate with its membership demographics. Officers are active participants in the ACRP Chapter Chairs Conference calls and always willing to give advice and guidance to other chapters that are just starting out.

In addition, the chapter continues to be a leading innovator in the area of its Web site which is an important resource for communicating with the clinical research community and providing revenue for the chapter through job posting fees. Chapter President Donna Godejohn, BSN, accepted the award on behalf of the Chapter."

Join a MN ACRP Committee
If you are interested in playing an active role on a MN ACRP committee, contact any of the Chapter Representatives. Get involved and help MN ACRP benefit its members and the clinical research community.