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April-2018 Full-Issue.Pdf Clinical Researcher™ The Authority in Ethical, Responsible Clinical Research April 2018 Volume 32, Issue 4 All contents © 2018 ACRP. All Rights Reserved Clinical Researcher—April 2018 (Volume 32, Issue 4) EXECUTIVE DIRECTOR’S MESSAGE Bringing the Team Together Jim Kremidas [DOI: 10.14524/CR-18-4025] With our ACRP 2018 annual meeting just 10 days away (as of the posting of this issue of Clinical Researcher), it’s an appropriate time to reflect on how we can all work together toward our common goal: providing the highest possible quality in the delivery of clinical trials. We’re all an integral part of a team effort full of dedicated professionals. Working together, we learn from each other. Learning together, we thrive. ACRP’s conference is an excellent opportunity for thought leaders to huddle together to share best practices. To build on what’s working and learn from what isn’t. You and your organization have some ambitious goals. We’ve been working with others in the industry to advance the professionalization of the clinical trial workforce by developing real- world standards based on the competencies required to be an outstanding researcher. We’re also working to spotlight some of the highest performers in our industry. That’s one of the many reasons we’re excited about working with The Avoca Group to jointly recognize leading sponsors and contract research organizations (CROs) at the ACRP/Avoca Awards & Recognition Ceremony on Friday, April 27, during our annual meeting. Finalists for the ACRP/Avoca Quality Awards were chosen by investigational sites through a research study conducted in conjunction with The Avoca Group over an eight-week period in early 2018. Investigational sites were asked to rate sponsor and CRO attributes (including responsiveness to questions, knowledge of the study protocol, and frequency of clinical research associate turnover, among others) and study execution (including setting of realistic patient recruitment goals, design of case report forms, and ease of electronic data capture systems, etc.). We hope this award will serve as another way to highlight some of the best and brightest in our industry. We should celebrate as we learn from first-in-class operations! On another note, it’s vitally important for us as an industry to find new ways to work closely with clinicians in the healthcare delivery marketplace. We have a tremendous opportunity to complement each other’s work in our communities at the local level. Clinical trials are a vital catalyst for healthcare innovation. It’s time for clinical practitioners and clinical research professionals to redouble efforts to educate potential patients on the benefits of trials as another valuable tool in a patient’s broader health regimen. I look forward to seeing you at the conference. Jim Kremidas ([email protected]) is Executive Director of ACRP. Clinical Researcher—April 2018 (Volume 32, Issue 4) CHAIR’S MESSAGE Spring into ACRP 2018 Kathryn Kimmel, CCRC, CCRA, ACRP-CP, FACRP [DOI: 10.14524/CR-18-4023] Spring greetings! As we enter a new season and look forward to an awakening of the Earth here in North America, my thoughts turn to our ACRP 2018 annual meeting, which runs April 27–30 at the Gaylord National Resort & Convention Center just outside Washington, D.C., in National Harbor, Md. I always find that my passion for research is renewed each year I attend the annual meeting, and it is so appropriate that it coincides with the beginning of spring. The volunteers on our Content Advisory Board have worked tirelessly with the ACRP staff to bring to our members an exciting program this year. Since the meeting will be in the D.C. area, we are expecting a significant presence of visitors from the U.S. Food and Drug Administration, National Institutes of Health, and other local and regional governmental and nongovernmental organizations with ties to healthcare and human subjects research. This is also an exciting year because of our first-ever collaboration with the Avoca Quality Consortium to hold the all-day 2018 Quality Congress (not included in the price of Full Conference registration) on Friday, April 27. We also have an exemplary lineup of vendors in the Expo Hall that should interest all attendees. We hope everyone will be able to join us during the Expo Opening Celebration in the Expo Hall on Friday evening, to be followed by an ACRP/Avoca Awards & Recognition Ceremony (the ceremony is included in the Quality Congress’s $599 price or for $100 separately). In addition to the regular educational sessions and networking events on tap in the Full Conference schedule Saturday through Monday, don’t forget that a variety of Friday half-day and full-day workshops may be purchased individually when you register, whether or not you will be in town for the rest of the meeting. As always, I look forward to seeing my many research friends and colleagues during the meeting, as well as to making new friends. If you have not already registered to attend this year’s event, there is still time to make arrangements. I promise you will find it informative and rewarding. Kathryn Kimmel, CCRC, CCRA, ACRP-CP, FACRP, ([email protected]) is a Senior Clinical Research Associate with PRA Health Sciences and the 2018 Association Board of Trustees Chair for ACRP. Clinical Researcher—April 2018 (Volume 32, Issue 4) MANAGING EDITOR’S MESSAGE The ABCs of IRBs and AMCs Gary W. Cramer [DOI: 10.14524/CR-18-4024] If letters are the building blocks of the alphabet, then acronyms are surely the building blocks of clinical research. Where would we be without our CRCs, CRAs, and PIs dealing with CROs and handling EDC as they work on ePROs, eCOAs, CTMSs, eTMFs, and so on following the expectations of FDA, NIH, OHRP, EMA, ICH, and the HRPP in order to file INDs, IDEs, NDAs, and on and on and on? Whew. In this issue, we turn our attention to the contributions made by professionals behind two of the clinical research enterprise’s bedrock acronyms—the folks in IRBs and AMCs. Brand new to the field? Then I’ll spell it out that we are dealing here with institutional review boards (also known as ethics committees) and academic medical centers. We’re happy to feature a variety of talented contributors who have brought their unique perspectives to bear on some of the opportunities, challenges, and rationales behind how and why well-functioning IRBs and AMCs are critical to clinical research. Meanwhile, speaking of acronyms that are associated with this issue’s theme, did you know that…: • If you want to become a Certified IRB Professional (CIP®) or Certified Professional Institutional Animal Care and Use Committee (IACUC) Administrator (CPIA®), you should learn more about the PRIM&R (Public Responsibility in Medicine and Research) organization. • If you want to demonstrate your organization’s commitment to ethical research with volunteers, you should learn more about the AAHRPP (Association for the Accreditation of Human Research Protection Programs) organization. • If you want to connect your AMC with institutions having similar missions, you should learn more about the AAHC (Association of Academic Health Centers). • ACRP members who have questions to ask and/or insights and resources to share about IRBs, AMCs, or any other acronym under the clinical research sun can do so through the ACRP Interest Groups and ACRP Online Community. That’s enough for now, IMHO. TCOY, everybody. Gary W. Cramer ([email protected]) is Managing Editor for ACRP. Clinical Researcher—April 2018 (Volume 32, Issue 4) PEER REVIEWED Study Start-Up Obstacles at an Academic Medical Center and How to Overcome Them Julie Agriesti, CCRC; Paula Smailes, RN, MSN, CCRC, CCRP [DOI: 10.14524/CR-17-0026] Few clinical trials are lucky enough to experience no start-up obstacles at an academic medical center (AMC). More often than not, these sites have a multitude of issues to overcome getting a study off the ground; however, sponsors are paying more attention to how long it takes sites to navigate the process from site feasibility and qualification to budget/contract execution and first patient enrolled. Site staff must take note of what kinds of obstacles they face. Knowing how these obstacles can be addressed and their associated processes improved will put sites in a position of being more appealing to sponsors when they are recruiting potential sites for new studies. For this reason, it is advantageous for site leaders to be proactive on what may be an issue at start-up, in an effort to streamline the process for future studies. Feasibility It is common for sponsors to send out feasibility questionnaires to determine if various sites might be qualified to conduct one of their studies. These assessments may elicit data from a site, such as metrics of their patient population or whether or not sites have the designated staffing or equipment. When it comes to site data, it may be challenging to get patient metrics in the time allotted to return the feasibility form. In an effort to be proactive, site staff should get updates on patient population metrics on a quarterly basis, so that the information is easily accessible when feasibility questionnaires arrive. Sites may also develop a website or brochure with this information to be easily accessible to sponsors. The bottom line is to make your site look ready and marketable for the next study. Checklists for Quality Once a feasibility questionnaire has been received, a study start-up checklist may be created in the eventuality the site is accepted for the study (see Table 1); this can help to keep the start-up process on track.
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