scholarly journals 2353

2017 ◽  
Vol 1 (S1) ◽  
pp. 48-48
Author(s):  
Megan Hoffman ◽  
Jennifer Maas ◽  
Lisa Johnson

OBJECTIVES/SPECIFIC AIMS: To increase knowledge and application of clinical research coordinator competencies among Research Professionals at the University of Minnesota. METHODS/STUDY POPULATION: The UMN’s CTSI developed and piloted a Foundations for Research Professionals training program comprised of: a baseline assessment, 7 online modules, 4 in-person training sessions, video and reading assignments and a post assessment, which totaled 30–35 hours of training and covered the following topics: preparing for a study, study management, participant recruitment and engagement, assessing capacity to consent and the informed consent process. This course also provides valuable resources and connections to online references and materials. The competencies for this program were based on work of the Joint Task Force for Clinical Trial Competency. RESULTS/ANTICIPATED RESULTS: 30 clinical research professionals completed the pilot program and averaged an increase of 6.5% from baseline assessment to post assessment. Participants were asked to rate their confidence on a variety of role-based competencies at the time of preassessments and postassessments. Trends show an increase in confidence for all competency areas after completion of the training program. DISCUSSION/SIGNIFICANCE OF IMPACT: Developing a workforce of competent research professionals is integral to improve the efficiency, quality, and ethics of research. The Foundations for Research Professionals training program increased knowledge of clinical research coordinator competencies. We will assess impact on application of the competencies 6 months after completion of the program. Our next steps include offering the training program as a 2-week session on an ongoing basis for new coordinators at the University of Minnesota.

2020 ◽  
Vol 4 (s1) ◽  
pp. 58-58
Author(s):  
Jennifer Maas ◽  
Megan Hoffman ◽  
Jessica Wright

OBJECTIVES/GOALS: Coordinating research studies is multifaceted and requires a foundational level of research knowledge, skills and abilities in order to contribute to high-quality, ethical research projects that adhere to local and federal regulations as well as Good Clinical Practice. Oftentimes, coordinators who are new to research or new to an institution have trouble navigating the research landscape. Departments within the University of Minnesota have limited resources to devote to developing robust training programs above and beyond protocol or department-specific training. Therefore, UMN’s CTSI created a comprehensive training and support program for research professionals at the University of Minnesota. METHODS/STUDY POPULATION: CTSI employs several strategies to provide a comprehensive training program for the University of Minnesota Research Workforce. The offerings are based on the The Joint Task Force for Clinical Trial Competency (JTF). In addition to training programs, valuable resources, materials, and connections are provided to trainees.An Onboarding process for new coordinators that includes a welcome email upon hire that provides resources as well an opportunity to meet face-to-face to get their questions answered about where to start with research training.Foundations for Research professionals, two week (20 hour) training program, provides a foundational level of knowledge to new coordinators via in-person and online training modules.Informed Consent 1 & 2 provides in-person training on the informed consent including the process, documentation, and ethical issues around consenting vulnerable populations.Over 40 on-line research training modules that coordinators can take at anytime.An active list serv that connects >600 research professionals with training updates and opportunities.Bi-weekly seminar series that provides a forum to share current regulations, best practices, resources, and guidelines pertaining to clinical research at the University.An online training “Roadmap” tool that customizes individual research training plans, and includes an inventory of training available.RESULTS/ANTICIPATED RESULTS: 218 research professionals participated in our Foundations blended training program with 191 completing (88% completion rate) the entire training. A comprehensive assessment based on national competencies is completed by all participants at Baseline and Post training. Baseline scores average at 75% and Post scores average at 82% (7% increase). Satisfaction is measured and participants are overall satisfied with the training, 4 out of 5 on a Likert Scale.353 research professionals have participated in our Informed Consent Session 1 & 2 in-person training. Satisfaction is measured and participants are overall satisfied with the training, 4.5 out of 5 on a Likert Scale.Over 190 research professionals have utilized our research on-line training modules.Training participants have been from 27 different departments across the University.The Clinical Research Professional Development Seminar Series has offered over 87 seminars with 4907 total attendees. These seminars are offered in-person and live stream.DISCUSSION/SIGNIFICANCE OF IMPACT: Establishing a comprehensive training program at the University has streamlined the training that research professionals receive across departments. It also ensures that all coordinators have access to research training, a network of other research professionals, resources, and continuing education opportunities.


2020 ◽  
Vol 4 (6) ◽  
pp. 485-492
Author(s):  
Stephanie Schuckman ◽  
Lynn Babcock ◽  
Cristina Spinner ◽  
Opeolu Adeoye ◽  
Dina Gomaa ◽  
...  

AbstractIntroduction:Acute care research (ACR) is uniquely challenged by the constraints of recruiting participants and conducting research procedures within minutes to hours of an unscheduled critical illness or injury. Existing competencies for clinical research professionals (CRPs) are gaining traction but may have gaps for the acute environment. We sought to expand existing CRP competencies to include the specialized skills needed for ACR settings.Methods:Qualitative data collected from job shadowing, clinical observations, and interviews were analyzed to assess the educational needs of the acute care clinical research workforce. We identified competencies necessary to succeed as an ACR-CRP, and then applied Bloom’s Taxonomy to develop characteristics into learning outcomes that frame both knowledge to be acquired and job performance metrics.Results:There were 28 special interest competencies for ACR-CRPs identified within the eight domains set by the Joint Task Force (JTF) of Clinical Trial Competency. While the eight domains were not prioritized by the JTF, in ACR an emphasis on Communication and Teamwork, Clinical Trials Operations, and Data Management and Informatics was observed. Within each domain, distinct proficiencies and unique personal characteristics essential for success were identified. The competencies suggest that a combination of competency-based training, behavioral-based hiring practices, and continuing professional development will be essential to ACR success.Conclusion:The competencies developed for ACR can serve as a training guide for CRPs to be prepared for the challenges of conducting research within this vulnerable population. Hiring, training, and supporting the development of this workforce are foundational to clinical research in this challenging setting.


2020 ◽  
Author(s):  
Liran Chen ◽  
Zhimin Chen ◽  
Huafang Chen

Abstract Objective: The changes of absolute value and relative value of clinical research coordinator service fee and its influence on the quality of drug clinical trial were analyzed.Methods: This study compared the amount and structural changes of drug clinical trial costs in before 3 years and after 3 years of self-examination and inspection initiated by the China Food and Drug Administration, identified the increase number and composition of each individual cost of a clinical trial research funds which including clinical research coordinator service fee, investigator labor fee, subjects examination fee, subjects traffic subsidy, documents management fee, drug management fee, etc.Result: The most significant appearance and increase in volume and proportion were the clinical research coordinator service fee. From the initial few to the global multicenter tumor drug clinical trials RMB31,624 or 34.92% of the proportion and domestic multicenter tumor drug clinical trials RMB16,500,accounted for 33.74%.Discussion: It has become common for more money to be spent on clinical trials to be accompanied by improved quality, but the occurrence and continuous increase of clinical research coordinator service fee were divided into two aspects, On the one hand, the quality of clinical trials was promoted by the large amount of low-skill trivial work undertaken by clinical research coordinator; on the other hand, the quality of clinical trials was undermined by the fact that clinical research coordinator did too much treatment evaluation work that should have been done by the investigator.


2018 ◽  
Vol 2 (S1) ◽  
pp. 51-51
Author(s):  
Jacqueline Knapke ◽  
Brett Kissela ◽  
Lynn Babcock ◽  
Schuckman Stephanie

OBJECTIVES/SPECIFIC AIMS: Acute care research is a unique area of clinical research that demands specialized skills, knowledge, and talents from empathetic professionals working in the field. Building off existing competencies for clinical research professionals, the Cincinnati Acute Care Research Council (ACRC) developed additional areas of competency for professionals working in the acute care research discipline. METHODS/STUDY POPULATION: Qualitative data obtained from job shadowing, clinical observations, and interviews were analyzed to understand the educational needs and desires of the acute care research workforce. We then utilized Bloom’s Taxonomy to build acute care research competencies that are measurable for job performance and build off of foundational clinical research professionals’ domains and competencies developed by the Joint Task Force of Clinical Trial Competency. RESULTS/ANTICIPATED RESULTS: Results suggest 35 special interest competencies for acute care clinical research professionals under 8 common domains set by the Joint Task Force of Clinical Trial Competency. Additionally an approved ACRC tactic, from actionable learnings through community assessments throughout 2017, is the creation of a Task Force made up of acute care research Principal Investigators and Clinical Research Directors to focus on the identified training and professional development obstacles in the clinical research enterprise. DISCUSSION/SIGNIFICANCE OF IMPACT: The competencies developed for acute care research should serve as guidelines for training a workforce prepared for the challenges of conducting research with each acute audience, as its own vulnerable population. These competencies will guide development of a multi-pronged program of professional development that will include new hire onboarding, new hire on-job training, and ongoing on-job training.


2018 ◽  
Vol 2 (S1) ◽  
pp. 51-52
Author(s):  
Jennifer Maas ◽  
Megan Hoffman ◽  
Janet Shanedling ◽  
Jason Kadrmas ◽  
Trung Ngo ◽  
...  

OBJECTIVES/SPECIFIC AIMS: To respond to the need for a simple tool to answer individual researchers questions: Exactly what training do I need to complete for my study and my role? Where can we go to find a comprehensive record of my research training? METHODS/STUDY POPULATION: Identify the factors that determine what training is required for each role (i.e., PI, coordinator, biostatistician) at the University, their role on the research study, type of funding, population being studied and responsibilities/duties on the research team. Develop an inventory of training required according to federal and local regulations and guidelines. Identify other related factors that ensure ongoing compliance for research professionals (i.e., medical licenses, CVs, immunizations, and credentials). Collaborate with programming professionals to explore and confirm the feasibility of such a Web site. Incorporate formal usability and pilot testing as part of the programming design process. Develop User Guide and Marketing and Launch plan for users and supervisors. Implement phased launch of the site with Google analytics, and evaluate the experience of phase I users. RESULTS/ANTICIPATED RESULTS: Three months user data and evaluation results demonstrated: 149 users created Training Roadmaps on the site. Users were from 67 different department codes, with the Department of Psychiatry the primary user. 20 users responded to a survey three months after launch. Research coordinators were the primary focus for phase I and represented almost half of the users. Survey respondents rated the site ease of use and clarity of the site as its greatest benefit. DISCUSSION/SIGNIFICANCE OF IMPACT: In September 2017, CTSI launched a new web-based training tool exclusively for University of Minnesota clinical research professionals who work with human participants, and their supervisors. The Human Research Training Web site is a free, easy-to-use tool to help identify and maintain the appropriate training, certification, credentials, and immunizations needed to perform University of Minnesota research with human participants. The Web site offers the University’s first systematic way to identify which research training is necessary for each research professional, and a system to track and maintain training compliance. Training records and information from the University of Minnesota’s central databases are securely integrated into this tool. Our Web site tool enhances research compliance. Any given study team member’s training requirements vary based on several criteria such as: role at the University, role on the research study, type of funding, population being studied and responsibilities/duties on the research study. The research training Web site generates required and optional training based on individuals’ responses to these questions. This Web site also links to the training, which decreases error in taking the wrong training. Furthermore, it provides completion data for research training and is a repository for vital study information such as: medical licenses, CVs, and credentials. Supervisors are able to view training and credentials. They are alerted when one of their employee’s licenses or certificates are about to expire. Uses-to-date and evaluation feedback have informed the need for a second phase of Web site enhancements. This site will reside in both the CTSI Web site and the HRPP Web site. A link will be sent to all new University research employees upon hiring. The Human Research Training Web site will likely have applicability to other universities in addition to the University of Minnesota.


2020 ◽  
Vol 54 (1) ◽  
pp. 1-20 ◽  
Author(s):  
Stephen A. Sonstein ◽  
Rebecca J. Namenek Brouwer ◽  
William Gluck ◽  
H. Robert Kolb ◽  
Carmen Aldinger ◽  
...  

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