August 2013 Consortium of Academic Programs in Clinical Research Newsletter 2013 Annual Meeting Minutes – 10 Year Anniversary June 26, 2013- at Drug Information Association Current Officers President (2013-2014) Carolynn Thomas Jones, MSPH, RN cjthomas@uab.edu University of Alabama at Birmingham, School of Nursing Treasurer (2013-2015) Marjorie Neidecker Marjorie.neideker@osumc. edu Ohio State University Meeting Attendees: Joan Butler, George Washington University; Bernie Cohen, CAAHEP; Esther Daeman, ACRP; Michael Drues, Industry; Barbara Gladson, Rutgers University, Secretary CoAPCR; Sue Fish, Boston University; Brenda Jamerson, Campbell University; Greg Koski, ACRES; Joao Massud, Federal University S Paulo Brazil; Lisa Palladino, Rutgers University; Raymond Panas, George Washington University; Jim Parmentier, Rutgers University; Bill Pickard, Campbell University; Peter Rheinstein; Anju Shrestha, Student at Rutgers University; Sandy Shire, Arizona State University; Honorio Silva, IFAPP; Stephen Sonstein, Eastern Michigan University, Treasurer CoAPCR; Mary Tobin, ACRES; Sameer Thapar, Rutgers University; Carolynn Thomas Jones, University of Alabama at Birmingham School of Nursing, President CoAPCR; Jim Thomasell, ACRP; Matthew Whalan, ACRES; Lawrence Stern, Merck; W. Thomas Smith, University of Florida; Sara Perkel, Drexel Univ. Remote attendees: Paul Beninger, Regina Ponder, Gateway Community College. I. Welcome and Introductions: Carolynn Thomas Jones, President, CoAPCR and faculty at the University of Alabama at Birmingham, opened the meeting, welcoming faculty members from CoAPCR member institutions and potential new CoAPCR members. She also welcomed visitors from industry, ACRES, ACRP, DIA and IFAPP. Carolynn noted that this meeting commemorated a 10 year anniversary for CoAPCR, noting the beginnings of the group in 2003 with a gathering at DIA that included: Steve Sonstein (Eastern Michigan University), Tony Dren and George Turner (Duke), Carlton Hornung (Univ of Louisville), Richard Day (Univ of New South Wales), Margaret Skelton (George Washington U), Elliot Sogol (Campbell Univ) and Ken Getz (Tufts). She gave a brief overview of CoAPCR accomplishments since last year, gaining acceptance from CAAHEP of CoAPCR and the clinical research professions; contributions to harmonized core competencies in clinical research and new strategic alliances. Additional details of those accomplishments were highlights of the agenda and are summarized below. II. Invited Speaker: Jim Thomasell, Executive Director of ACRP discussed ACRP’s career development pathway that will be headed by Esther Daemen. They have surveyed their members and found that individuals want 1. Content that is accessible anywhere in the world; 2. Content that is affordable; 3. Content that is engaging and relevant; and 4. Content that is updated regularly. ACRPs key focus in education will focus on three main content aims: Human Subject Protections; Data Quality, and Regulatory Compliance. Also based on survey results, members want to establish clear job roles that are standardized across institutions and the profession. To accomplish this, ACRP is working with other stakeholders to establish competencies through the newly formed Task Force on Clinical Research Competencies, which CoAPCR is a member. From the competencies that have been establish to date, they have developed learning domains. These learning domains will then become the focus of their continuing education process and certification. The content areas include human subject protection, integrity of data, and regulatory compliance. Courses will be offered in these areas at variable Instructional Levels: basic, intermediate, and advanced. Career development pathways are being developed for the CRC, CRA and PIs. Discussions are underway with ACRP to define best pathways for CoAPCR students to gain certification “experience credit” as they complete their degrees. Secretary (2012-2014) Barbara Gladson, PhD Barbara.Gladson@shrp. rutgers.edu Rutgers University The Consortium of Academic Programs in Clinical Research (CoAPCR) is an independent, nonprofit corporation whose mission is to: - Provide a medium of communication among educators of clinical research professionals - Support the development and maintenance of clinical research education programs - Foster collaboration between educational institutions, clinical facilities, professional associations and industry. Page | 1 2013 Annual Meeting Minutes Continued “Individuals want clinical research courses that are accessible, affordable, engaging and content relevant. ACRP is dedicated to 3 key content aims: human subject protection, data quality and compliance with regulations.” III. Update on Core Competencies- Dr. Steve Sonstein, Treasurer and Professor, Eastern Michigan University, discussed the efforts of the Joint Task Force on Clinical Trial Competency comprised of over a dozen organizations including the Multi Regional Clinical Trials Initiative (Harvard), CoAPCR, the Clinical Trials Transformation Initiative (CTTI/Duke), Alliance for Clinical Research Excellence and Safety (ACRES), ACRP, MAGI, Transcelerate, CITI and others. The mission is to harmonize core competencies in clinical research which will have impact on education, training, job descriptions, and even certification of clinical sites. Each stakeholder has their own specific interests, but the commonality is standardization of the competencies to benefit the clinical research enterprise and public health. Both Steve and Carolynn have been participating with the task force. The group is expected to present their work at the next MAGI conference in October, 2013 in Las Vegas. Once their competencies are published, the Consortium can begin to finalize the core competencies with our accreditation documents, and begin the more difficult task of dealing with the fact that our programs have slightly different emphases and some award associate degrees while others award Bachelors, Masters, or PhDs. IV. Update on Accreditation- Dr. Steve Sonstein, Chair of the Council on Accreditation (CoA) being formed by CoAPCR. He reviewed the expected organizational structure of our future CoA. The CoA is expected to be a separate independent body with its own 501c3 status. It will be charged with developing the accreditation standards and conduct site visits. This committee will be made up of several stakeholders including individuals from academic institutions as well as some from industry. The CoAPCR CoA, when fully formed, will pay $3000.00/yr to CAAHEP and provides one member to sit on the CAAHEP Board. Currently Steve Sonstein is the CoAPCR representative to the CAAHEP Board. The CoA will be soliciting “Supporting Organizations,” those involved in hiring our graduates, or even some academic institutions to join this status of CoAPCR membership for an annual fee of $1000.00. All Supporting Organizations can nominate a representative to sit on the CoAPCR CoA. A representative of CAAHEP, Dr. Bernie Cohen, attended our meeting today and a meeting of the Accreditation Committee on June 25th. There were several questions regarding how to develop one set of standards for programs that are somewhat different in scope and mission. A process will be developed to outline how sites can apply standards (competencies) to curriculum and courses. V. ACRES Update- Dr. Honorio Silva (IFAPP/ACRES) presented an update on ACRES and discussed their mission, goals and objectives. Their goal is to bring together various stakeholders to build a global clinical research system that would be connected by standardized policies, have staff that is certified as well as developing a mechanism to certify research sites. For more information on this initiative, please see www.acresglobal.net. VI. Business Meeting: Steve provided a treasurer’s report. Jim Parmentier and Sara Perkel are working on revisions to the Bylaws and will present those during future teleconference meetings. Marjorie Neidecker, Ohio State University, has been nominated as Treasurer. Cris Wells, Arizona State University and Marjorie Neidecker, Ohio State University will assume website responsibilities. Carolynn is working on a revised member directory and will provide website details to Cris and Marjorie. -Jim Thomasell, Executive Director, ACRP CoAPCR Updates are found at http://www.coapcr.org TIME TO RENEW! Update your Membership Information Pay Annual Dues Notify us of new programs 2|Page 2013 Annual Meeting Minutes Continued VII. Membership: Now is the time for member renewals. Please utilize the membership form in our website to renew your membership. Institutional costs of membership remains at $100 per year. Our fiscal year is from July 1, 2013 to June 30, 2014. All faculty from your member institution are eligible to participate in CoAPCR Teleconferences , service and meetings. Each institution has a single vote on key issues. We want to know your faculty, so please share details of your faculty names, email, phone contact and websites so that we can be sure to represent you fully on our website. Also, each CoAPCR faculty is encouraged to send reference lists that include your scholarly work on clinical research education, collaborations and research operations. This website is an additional place for you to feature your scholarly work in our field. VIII- Upcoming Conferences: CoAPCR values collaboration with the various organizations that represent the clinical research profession. Our members have traditionally been quite active, especially at professional meetings and several opportunities exist for our students to participate and take advantage of the careerbuilding and professional learning opportunities that these meetings provide. Students are encouraged to submit abstracts for poster presentations at DIA and ACRP and several have actively participated in the past. MAGI is now collaborating with COAPCR and sponsoring an upcoming writing/professional presentation contest for students. This is meant to encourage membership, increase poster submissions and meeting attendance by students and will be an important link to their future professional endeavors. We model that and we support it. Please be sure to E-mail students and include announcements as they are released- to your course home-pages. IX- Next CoAPCR Teleconference: Friday, September 13, 2013 at 11:00 AM EST. You may link to this call here (please test your connection in advance): https://uab.wimba.com/launcher.cgi?room=_uab_s__254654_1_428041 SoCRA 22nd Annual Conference. New Orleans, LA Sept 27-29, 2013 3|Page