Chapter News
MN ACRP to Host Summer Social at Champps in St. Paul on Tuesday, July 20th, 2010
From Paul Below
July 2010
The MN ACRP is hosting a Summer Social on Tuesday, July 20th from 6:00-8:00 pm at Champps (2401 7th Street West, St. Paul, MN 55116). Join fellow research professionals for an evening of conversation, food and fun. This event will also highlight clinical research educational opportunities from the following programs:
» Anoka-Ramsey Com. College - Clinical Research Prof. Certificate
» Saint Cloud State University - Applied Clinical Research MS
» University of Saint Thomas - Clinical Professional Certificate
» Walden University - Clinical Research Administration MS
Food and beverages will be provided. To register, please email your Name, Title, Company and E-mail Address to 
e-mail.
MN ACRP Hosts May 2010 Program "FDA Guidance on Investigator Supervisory Responsibilities"
From Programming Committee
May 2010
On May 20th, 2010, the MN ACRP hosted the evening program, "FDA Guidance on Investigator Supervisory Responsibilities" by Paul Below, CCRA, CCRT. Paul discussed the general purpose of the FDA’s new guidance, the history of it's development, and what the FDA considers to be adequate supervision of study staff and other third parties and the appropriate delegation and adequate training of study-related tasks. View his presentation (PDF, 404 KB).
There were about 60 members who attended the event was hosted forthe first time at the excellent facilities of St. Joseph’s Hospital (3M Conference Room) in St. Paul, MN, Thank you to Nancy Stinnett, MN ACRP Immediate Past President and employee at St. Joseph's for arranging the meeting space. Special thanks also to Suzanne Logan, CCRP, Clinical Research Coordinator at National Marrow Donor Program, for leading the planning of this successful event.
St. Cloud State University Officially Launches New Masters Degree Program in Applied Clinical Research
From Paul Below
May 2010
St. Cloud State University will begin offering a new Master’s of Science in Applied Clinical Research degree program this fall uniquely focused on the medical technology industry. St. Cloud State’s Applied Clinical Research degree will provide professionals with the necessary skills, tools and competencies needed to design, conduct, manage, and evaluate human clinical trials for the medical device industry. Like the Regulatory Affairs master’s degree offered at St. Cloud State, it leveraged a powerful group of top industry experts in Minnesota to create the unique curriculum that targets an underserved area of the medical device industry in significant need of more, well trained professionals.
Classes will be held evenings and weekends at the St. Cloud State Twin Cities Graduate Center in Maple Grove. Interested students may contact the SCSU College of Science and Engineering at 320-308-2167, or by email to acr@stcloudstate.edu, and for more information visit the program website at www.msacr.com. Download the official press release.
MN ACRP Hosts March 2009 Program "Incidental Findings in Genetic Research: Implications for Researchers"
From Nancy Stinnett
March 2009
On March 19, 2009, the MN ACRP hosted the evening program, "Incidental Findings in Genetic Research: Implications for Researchers" by Bonnie S. LeRoy, MS, CGC. There were about 50 members who attended, and 20% were first time event attendees or had not attended a Chapter meeting in the last two years. Bonnie was an awesome speaker and was engaging and informative. I thought it was fun to participate on the case studies and there was lots of participation by the members. Thank you to Denise and Brenda and the MN ACRP Programming Committee for planning and executing this successful event.
MN ACRP Hosts November 2008 Symposium "Teaming-Up to do Clinical Research"
From Programming Committee
November 2008
On November 22, 2008, the MN ACRP hosted the half-day symposium, "Teaming-Up" to do Clinical Research: What it takes to put it all together. 98 people attended including 76 chapter members. The speakers were Tom Kuhn, Owner of Qnity, Inc, (KEY NOTE): Getting Your Team on the Same Page, One Page at a Time; Karen Margolis, MD, senior clinical investigator at Health Partners Research Foundation: What makes a Successful Clinical Research Team: A PI’s Perspective; Jeffrey Probstfield, MD, Director of Clinical Trials Service Unit and Professor of Medicine (Cardiology) at the University of Washington, School of Medicine: Lesson Learned: Adherence and Retention of Participants in Long-term Trials; and Chuck Swanson, Director of Business Development, Center for Information and Study on Clinical Research Participation (CISCRP): The Powerful Role of Outreach and Education. To view their presentations, go to the Past Presentations page.
Special thanks to the volunteers who helped put on this excellent event including Brenda Kirpach (event co-chair), Denise Windenburg (event co-chair), Andrea Metzig, Nancy Stinnett, Pamala Pawloski, Lorry Witte, Pamela Wolfe, Karen Hartman, and Paul Below.
ACRP Announces New Fees for Contact Hours for Chapter Events in 2009
From the Global ACRP Headquarters
October 2008
ACRP has approved a new policy to collect a fee for all ACRP provided contact hours including contact hours obtained via chapter events. Beginning January 2009, all ACRP chapters will be implementing this new policy by including a minimal charge for attendees to obtain contact hours from chapter events. Please note that this is a Global ACRP policy change and all local ACRP chapters are required to comply.
The new fee for contact hours will be determined by the quantity of hours offered at the event and will be collected with the registration fee. The charges for ACRP members will be:
- For events with less than 3 contact hours = $10
- For events with 3-5.99 contact hours = $20
- For events with 6+ contact hours = $30
ACRP notes: "Because we also understand that being able to obtain contact hours is a valuable benefit for chapter members, we have done our best to keep the charge for chapter contact hours the lowest from ACRP. The intent of the new policy is not to limit the participation with chapter educational events, rather to ensure that ACRP has the financial resources to continue to provide these programs. As a non-profit entity, the maintenance and growth of our programs relies on the continued financial support of our members. We hope you continue to take advantage of the quality local education and networking opportunities organized by your local chapter and we thank you for your dedication to the organization and commitment to the profession." For questions or concerns about this new policy, please contact Megan Markowski at ACRP, e-mail.
Medical Device Alliance Renews Website Sponsorship
By Paul Below, Communications Committee
October 2008
Thank you to the Medical Device Alliance for their continued support of MN ACRP through their sponsorship of our website. To learn more about the Medical Device Alliance, visit their website at www.mfrall.com.
MN ACRP Hosts September 2008 Program on Liability Issues with Clinical Trials
By LeAnn Anderson, Programming Committee
September 2008
At MN ACRP’s September 18, 2008 program, a large audience of clinical research professionals heard regulatory attorney Robert Klepinski, who is an Officer with Fredrikson & Byron, P.A., describe three major types of liability associated with clinical trials. Mr. Klepinski, who counsels pharmaceutical, medical device, biotech, food and nutritional supplement companies on FDA policy, discussed the areas of product liability, warranty and malpractice; criminal risk related to payments from sponsors to medical providers; and sponsor risk for assuming the first payer role as a health insurer in the case of injuries due to a clinical study. He illustrated each type of liability with cases and offered preventive strategies for sponsors and investigators.
ACRP members from Duluth attended via audio conference. Very special thanks to Sheryl Sturm and the Minnesota Heart Clinic staff at the Minnesota Heart and Vascular Center in Edina for their warm hospitality.
View his presentation (NOTE: Mr. Klepinski's slides are available on our web site for your educational use to supplement the live presentation. These copyrighted slides are not to be copied for any commercial purpose. You may not copy or use them, other than as an aid in your understanding the subject matter of our class).
MN ACRP Hosts February 2008 Program on Investigator-Initiated Clinical Trials from a Site Perspective
From the Programming Committee
March 2008
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 Awarded "Outstanding Chapter" at 2005 ACRP Annual North American Conference
By Paul Below
September 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
By MN ACRP Board of Directors
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.
