May 2010

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Ethical Implications of Social Media in Clinical. Research. ... Enhanced Monitoring Tools and Strategies ... This webinar proposes a 10-step BEST-WORM model.





YEAR 2010



Greater Charlotte Association of Clinical Research Professionals


PRESIDENT’S CORNER Dear GCACRP Members, 2010 is nearly half complete and we’ve been able to offer some great programs so far this year including topics on subject recruitment and FDA audit preparedness! Be on the look-out for information about our August program and our Fall Conference. Thanks to our Program Committee, the agenda for our Fall Conference is coming together nicely and will be on the exciting and current topic of the use of social media in subject recruitment.

As a reminder, RSVPing for programs must be done via the ACRP national website at You can also purchase contact hours and complete

the post program evaluations via this website.

Before long we’ll be taking nominations for next year’s board members. If you’d like to participate in the organization and operation of GCACRP, please let a current board member know. Thank you for your current participation and I look forward to seeing you at any of our upcoming programs! -Melanie Bamberg 2010 President GCACRP

Treasure’s Report May 2010 Treasury Balance 12/31/2009: Revenue since 12/31/2009: Expenses since 12/31/2009: Current Treasury Balance 4/30/2010:

$16,383.78 $ 1,317.50 ($ 5,111.11) $12,590.17

Key Expenses: 2009 GCACRP Fall Conference: 2010 Seminar Expenses:

$ 3,323.98 $ 1,787.13


GCACRP COMMITTEES The Greater Charlotte Chapter of ACRP has a proud history of providing support

President Melanie Bamberg BCC / Total Cancer Care Carolinas Healthcare System Tel: (704) 355-6980

and educational opportunities to the Charlotte research community. This is done completely through the work of dedicated volunteers. If you would be interested in serving on any of our committees, please contact Melanie Bamberg or any of the committee chairs listed below. Program Committee Chair: Yvonne McCracken 704-366-3001 Assisted by Amy Eshelman 704-323-2263 Anne Dennos 704-323-2262 Melanie Hogg 704-355-4288

[email protected]

President-Elect Amanda Phillips OrthoCarolina Tel: (704) 323-2267 [email protected] om

Secretary Allison Dyer Blumenthal Cancer Center Tel: 704-355-1539 [email protected]

Treasurer Stephen Baldwin Carolinas Healthcare System Tel: (704) 512-4167 [email protected]

Winston-Salem Sub-Chapter Chair

Jennifer Short Forsyth Medical Center Tel: (336) 718-5871 [email protected]

Program Committee Chair Yvonne McCracken, MPH, CCRC

Carolinas Research Associates Tel: (704) 366-3001 [email protected]

Membership Committee Chair Malou Mortel-Andresen 704-355-6694

Publications Committee Chair Cindy McIntyre 704-355-4869

2010 GCACRP Event Registration Treasurer


ACRP has instituted a new method of registering for all events, for attendance and for receiving contact hours. All registrations will be done through the Greater Charlotte Chapter page on the ACRP Website. Log in at and follow the links to the Greater Charlotte chapter. Here you will be prompted to register for events either as a member (free including dinner), member requesting contact hours ($10, dinner is free), Non-member ($10 for dinner), or Non-member requesting contact hours ($35 for hours and dinner). Registration for events will only be available shortly before each event. If you purchase contact hours and attend the event, you will be sent an e-mail evaluation to complete to receive your contact hours.

Fall Conference 2010 With the new leaves barely out on the trees, your GCACRP Program Committee is already well at work planning the Fall Conference to be held on October 29 at UNCC. The topic will be Social Media and Research with our Keynote address by Michele Carter, PhD,: "MySpace or Yours: Ethical Implications of Social Media in Clinical Research.” [email protected] [email protected]

Upcoming ACRP Webinars: Trust-Based Influence and the Sponsor/CRO Relationship

WINSTON SALEM SUB-CHAPTER BOARD OF DIRECTORS: Sub-Chapter Chair Jennifer Short Membership Committee Chair Joanna Zakamarek Treasurer Seeking Chair Sponsorship and Networking Seeking Chair Program Committee Chair Bob Romanchuk

The complaints that Sponsors and CROs have about each other are legion and they never seem to end. Despite all the conferences, workshops and articles, the two groups still do not seem to understand how to work together effectively. This program will help attendees to understand the underlying causes of negotiation difficulty and conflict and provide a framework for planning and negotiating contracts and outcomes which are more likely to be implemented as agreed. 6/16/10

Enhanced Monitoring Tools and Strategies that Optimize Productivity and Compliance This webinar 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, and review techniques that supersede basic training and enhance clinical monitoring efficiency in US- based premarket trials. 6/23/10

Billing Errors in Clinical Research: Is There Room to Say “Oops”? This webinar proposes a 10-step BEST-WORM model defined as “Billing Errors System-wide TrimmerWorking Model) along with a detailed description of all 10 internal controls designed to reduce billing errors and how well they operate harmoniously to give a desirable output. 7/21/10 Register:

GCACRP was founded in June 1996. Our goals for establishing the chapter were to provide effective means to: •

Professional Interaction With Colleagues;

Advanced Continuing Education;

Providing A Readily Accessible Mechanism For Regional Program Development;

Furnishing Improved Access To ACRP Membership Resources and Opportunities Including Certification With Contact Hours.

Distribution List If you know of a research professional who would like to be on our Distribution List, please send contact information to Allison Dyer at 704355-1539 or email at [email protected] [email protected]

MEMBERSHIP: Commitment and Cooperation

We currently have 131 local chapter members. If you are interested in joining the local chapter, please sign-up online at ACRP membership is a prerequisite for chapter membership. Annual chapter dues are $20, which allows you to receive continuing education credits from our programs at a greatly discounted rate. We also provide complementary dinner at our meetings for chapter members. To join ACRP and the local chapter please follow this link: GetInfoFor/USChapters/ GreaterCharlotte.aspx

2010 GCACRP Programs Make sure you have marked your calendars for the upcoming GCACRP Programs: August 17, 5:00 p.m. Registration and Dinner, 5:30 Program MEB 3rd Floor Conference Room, CMC (Please note the change in date and location from previously announced.)

Michael Hammrell: “I Hate My PI, or How to Select Good Principal Investigators & Work with Them”

Fall Conference October 29 at UNCC: Social Media in Research ACRP's CCRA and CCRC Certification Programs Accredited by NCCA The Association of Clinical Research Professionals (ACRP) is pleased to announce the official accreditation of the CCRA® and CCRC® certification exam programs from the National Commission for Certifying Agencies (NCCA), the accreditation body of the Institute for Credentialing Excellence. Administered by the Academy of Clinical Research Professionals (the Academy), these exams are now the first and only certification programs in clinical research to earn this level of recognition. This prestigious, independent confirmation of the quality of ACRP certification applies to the Certified Clinical Research Associate (CCRA®) and Certified Clinical Research Coordinator (CCRC®) programs offered through the Academy, ACRP’s affiliate body for non-physician certification. Based in Alexandria, Va., ACRP first offered its CRC examination in 1992, and launched its CRA examination in 1995. The Academy has certified more than 14,200 CRCs and 7,600 CRAs to date. “Those who earn the CCRA and/or CCRC designation have demonstrated their understanding of and compliance with internationally accepted standards of clinical research practices for the conduct of studies of experimental medicines, medical devices, and other therapies involving human subjects,” said Kathryn Kimmel, CCRC, CCRA, chair of the Academy’s Board of Trustees. “In no small part, this accomplishment was made possible through the dedication of volunteers working behind the scenes to take programs that we knew were already of tremendous value to our certificants, and raise their quality to a level of excellence that distinguishes ACRP from all other clinical research organizations offering certification.” “Achieving official accreditation of the CRA and CRC certification programs was one of our top-ranked priorities in the ACRP strategic plan,” said Carol McCullough, director of credentialing and certification for ACRP. “This accreditation serves as independent verification that our programs are reliable and statistically valid.” Added David M. Vulcano, LCSW, MBA, CIP, RAC, immediate past chair of ACRP’s Association Board of Trustees and champion of this effort: “What this means is that ACRP is the first and only clinical research industry organization to join the ranks of other well-established and well-recognized healthcare (and non-healthcare) certifying bodies, many of whose certification products are state licensing requirements.” The NCCA accreditation is good for five years, through April 30, 2015. To earn accreditation, ACRP had to submit an application demonstrating the program’s compliance with the NCCA’s Standards for the Accreditation of Certification Programs. Since 1977, the Washington, D.C.-based NCCA has been accrediting certifying programs based on the highest quality standards in professional certification to ensure the programs adhere to modern standards of practice in the certification industry. There are 233 NCCA accredited programs that certify individuals in a wide range of professions and occupations, including nurses, financial professionals, respiratory therapists, counselors, emergency technicians, and more. Check it out!

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