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December-2016-Home-Study The New Shape of Workforce Development HOME STUDY TEST Earn 3.0 Continuing Education Credits This test expires on December 31, 2017 (original release date: 12/1/2016) ACRP EDITORIAL In this issue of Clinical Researcher, the three articles that follow this page have ADVISORY BOARD been selected as the basis for a Home Study test that contains 30 questions. For your Michael R. Hamrell, PhD, RAC, FRAPS, RQAP-GCP, CCRA (Chair) convenience, the articles and questions are provided in print as well as online (members only) in the form of a PDF. This activity is anticipated to take three hours. Erika J. Stevens, MA (ABoT Liaison) Suheila Abdul-Karrim, CCRA, CCRT Answers must be submitted using the electronic answer form online (members Victor Chen only, $60). Those who answer 80% of the questions correctly will receive an electronic Gregory Hale, MD, CPI Julie M. Haney, RN, BS, MSL, CCRC statement of credit by e-mail within 24 hours. Those who do not pass can retake the test Stuart Horowitz, PhD, MBA for no additional fee. Stefanie La Manna, PhD, ARNP, FNP-C Jamie Meseke, MSM, CCRA Grannum Sant, MD, BCh, BAO (Hons.), MA, FRCS, FACS ACRP DISCLOSURE STATEMENT CONTINUING EDUCATION Paula Smailes, RN, MSN, CCRC, CCRP As an organization accredited by the Accreditation INFORMATION Naveen Tirkey, PhD, CCRA: Nothing to Disclose Council for Continuing Medical Education (ACCME®), The Association of Clinical Research Professionals Jerry Stein, PhD (Vice Chair): the Association of Clinical Research Professionals (ACRP) is an approved provider of medical, nursing, Consultant to Encore Vision, Contractor (ACRP) requires everyone who is in a position to for various companies and clinical research continuing education credits. control the planning of content of an education activity to disclose all relevant financial relationships Contact Hours ACRP STAFF/ with any commercial interest. Financial relationships The Association of Clinical Research in any amount, occurring within the past 12 months Professionals (ACRP) provides 3.0 VOLUNTEERS contact hours for the completion of this of the activity, including financial relationships of a Gary W. Cramer educational activity. These contact hours Jan Kiszko, MD spouse or life partner, that could create a conflict of can be used to meet the certifications Jo Northcutt interest are requested for disclosure. maintenance requirement. Deepti Patki, MS, CCRC The intent of this policy is not to prevent indi- (ACRP-2016-HMS-012) Barbara van der Schalie viduals with relevant financial relationships from Continuing Nursing Education Christine Streaker participating; it is intended that such relationships Nothing to Disclose The California Board of Registered Nurs- be identified openly so that the audience may form Karen Bachman: ing (Provider Number 11147) approves Alcon speaker’s bureau their own judgments about the presentation and the the Association of Clinical Research James Michael Causey: presence of commercial bias with full disclosure of Professionals (ACRP) as a provider of con- Contributor, AssurX blog the facts. It remains for the audience to determine tinuing nursing education. This activity whether an individual’s outside interests may provides 3.0 nursing education credits. (Program Number 11147-2016-HMS-012) reflect a possible bias in either the exposition or the conclusions presented. Continuing Medical Education The Association of Clinical Research Professionals (ACRP) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing The pass rate for the medical education for physicians. The 80% Home Study Test is now Association of Clinical Research Profes- sionals designates this enduring material 80% to be in alignment with ACRP for a maximum of 3.0 AMA PRA Category professional development standards. 1 Credits™. Each physician should claim only the credit commensurate with the extent of their participation in the activity. Clinical Researcher 11 December 2016 HOME STUDY The New Shape of Workforce Development Project Managers Influence Parallel Planning and Collaboration Between Sites and Sponsors PEER REVIEWED | Romiya Barry, MSc | Joe Coffie, CCRA | Catherine Pui Yin Mok, MSc, CCRP, CCRC | Jill Chapman, BHSc, CCRA [DOI: 10.14524/CR-16-0005] Clinical research is a dynamic field. Changes in regulatory requirements, market demands, and clinical practice can affect clinical project design and study timing. To plan and execute a clinical trial today can take years and cost hundreds of millions of dollars, but what is most at stake is the relevancy of the drug or device to the intended patient or user. It is critical that studies are conceptualized, great tools for ensuring both parties (sponsor/ initiated, and reported efficiently. Successful trials CRO and site) have the opportunity to review tasks must be both scientifically sound and managed associated with the project. according to best practices, but it has been The project managers at the sponsor and site reported that many clinical trials fail to deliver also are responsible for communicating with because of the lack of a structured, practical, sys- one another about their respective project plans tematic approach to trial management.1 A robust using a pathway that can be documented for each clinical project plan can have a powerful impact study. This communication pathway facilitates the on increased efficiency in all phases of clinical parallel planning approach. In current practice, LEARNING OBJECTIVE trial development and implementation; this can be it is often the case that a sponsor shares its study supported by a strong, collaborative approach in timeline with the site during the investigator After reading this article, project management. meeting or site initiation visits, but regularly fails participants should be able to actually discuss the timeline and plans for to explain what parallel Parallel Planning in Project Management executing the study. planning is in project Use of project management systems can be Many business and project management systems management, provide optimized in a parallel planning approach by are available on the market. However, while the inputting site start-up timelines and enrollment rate examples of how it can be use of tools like SAP Business ByDesign, Microsoft projections (as two examples). With this information implemented in a clinical SharePoint Server, ProjectManager.com, ALLEGRO ® in hand, the sponsor can then look at the overall trial, and use it in their CTMS, and others may garner different results for study in a “big picture” view and make informed trials. different users, the importance is having effective decisions that may impact the study. For example, project leadership—whether identified by title or a particular region has one site that can be ready DISCLOSURES delineated based on the responsibilities of a person’s for a site initiation visit early, but is not expected to Romiya Barry, MSc; role—at the sponsor/contract research organization be a high-enrolling site, and the remaining 10 sites (CRO) and clinical site levels. Joe Coffie, CCRA; will be ready three months later. The sponsor may A representative for each entity involved in the Catherine Pui Yin Mok, MSc, decide to delay study launch in that entire region study should be responsible for initiating, plan- CCRP, CCRC: until the time that all sites are expected to be ready. ning, executing, and monitoring the project plan Nothing to disclose In so doing, the personnel resource requirements on his/her respective side of the overall project. would be optimized, and sponsor/CRO resources Jill Chapman, BHSc, CCRA: These project leads (project managers) ensure that would thus be directed to the other regions that are Employee of ACRP the tasks are carried out appropriately and accord- expected to be ready sooner. ing to the plan. Project management systems are December 2016 12 Clinical Researcher Study Timelines: A Shared TABLE 1: Shared Project Concept Review Responsibility Utilizing a consultative approach by involving all PROJECT MANAGER stakeholders as early in the project development as Sponsor Site possible takes into account the perspectives of the sponsor, the CRO, and the investigative site, thus Is this study Define reasonable eligibility requirements Confirm the site has an adequate targeted Feasible? and sample size for the protocol synopsis. patient population that correlates with the reducing chances of decreased scientific relevance protocol eligibility requirements. resulting from changes in standard-of-care that Clearly state the objectives and required Understand if the study procedures can occur while the clinical project is in development. activities of the protocol, limiting optional be performed appropriately with special Clinical trials guided by strong communication study activities unrelated to the objectives. attention to procedures outside the between sponsors and sites are more successful and standard of care at the site. enjoyable, as they contribute to “pride in ownership.” Specify equipment requirements that may Consider if any special equipment is All stakeholders should prospectively establish not be standard or in routine use at studies needed to perform the study procedures a clear understanding of each party’s responsibil- sites (e.g., research equipment vs. clinical described in the protocol. ities and of the expectations for the conduct of the equipment). project. Often, face-to-face communications about Determine with biostatistics and medical Evaluate
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