Association of Clinical Research Professionals (ACRP)

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.

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Education and training of clinical and translational study investigators and research coordinators: A competency-based approach

Journal of Clinical and Translational Science ◽

10.1017/cts.2016.2 ◽

2017 ◽

Vol 1 (1) ◽

pp. 16-25 ◽

Cited By ~ 21

Author(s):

Nancy A. Calvin-Naylor ◽

Carolynn Thomas Jones ◽

Michelle M. Wartak ◽

Karen Blackwell ◽

Jonathan M. Davis ◽

...

Keyword(s):

Clinical Research ◽

New Technologies ◽

Standardized Assessments ◽

Translational Study ◽

Clinical Research Coordinators ◽

Working Groups ◽

Competency Based ◽

Research Workforce ◽

And Training ◽

Research Professionals

IntroductionTraining for the clinical research workforce does not sufficiently prepare workers for today’s scientific complexity; deficiencies may be ameliorated with training. The Enhancing Clinical Research Professionals’ Training and Qualifications developed competency standards for principal investigators and clinical research coordinators.MethodsClinical and Translational Science Awards representatives refined competency statements. Working groups developed assessments, identified training, and highlighted gaps.ResultsForty-eight competency statements in 8 domains were developed.ConclusionsTraining is primarily investigator focused with few programs for clinical research coordinators. Lack of training is felt in new technologies and data management. There are no standardized assessments of competence.

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Ethical implications of procedural or protocol adjustments to clinical research involving the participation of human subjects during the COVID-19 pandemic

Ethics & Bioethics ◽

10.2478/ebce-2021-0018 ◽

2021 ◽

Vol 11 (3-4) ◽

pp. 181-195

Author(s):

Anetta Jedličková

Keyword(s):

Clinical Trials ◽

Clinical Research ◽

Human Subjects ◽

Subject Matter Experts ◽

Ethical Challenges ◽

Wide Audience ◽

Ethical Implications ◽

The Subject ◽

Research Professionals ◽

Trial Participants

Abstract The current coronavirus disease 2019 (COVID-19) pandemic has led to essential adjustments in clinical research involving human subjects. The pandemic is substantially affecting most procedures of ongoing, as well as new clinical trials related to diseases other than COVID-19. Procedural changes and study protocol modifications may significantly impact ethically salient fundamentals, such as the risk-benefit profile and safety of clinical trial participants, which raise key ethical challenges the subject-matter experts must face. This article aims to acquaint a wide audience of clinical research professionals, ethicists, as well as the general public interested in this topic with the legal, ethical and practical considerations in the field of clinical trials during the COVID-19 pandemic and to support the clinical researchers and study sponsors to fulfil their responsibilities in conducting clinical trials in a professional way that does not conflict with any legal or ethical obligations.

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Incorporating Competencies Related to Project Management into the Joint Taskforce Core Competency Framework for Clinical Research Professionals

Therapeutic Innovation & Regulatory Science ◽

10.1007/s43441-021-00369-7 ◽

2022 ◽

Author(s):

Stephen A. Sonstein ◽

Lisa Palladino Kim ◽

Nita Ichhpurani ◽

Roshan Padbidri ◽

Sarah A. White ◽

...

Keyword(s):

Project Management ◽

Clinical Research ◽

Core Competency ◽

Competency Framework ◽

Research Professionals

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2479 Acute care research competencies for clinical research professionals: A practitioner inquiry approach and assessment

Journal of Clinical and Translational Science ◽

10.1017/cts.2018.194 ◽

2018 ◽

Vol 2 (S1) ◽

pp. 51-51

Author(s):

Jacqueline Knapke ◽

Brett Kissela ◽

Lynn Babcock ◽

Schuckman Stephanie

Keyword(s):

Clinical Research ◽

Acute Care ◽

Task Force ◽

Care Research ◽

Joint Task ◽

Research Competencies ◽

Joint Task Force ◽

Trial Competency ◽

New Hire ◽

Research Professionals

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.

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2069

Journal of Clinical and Translational Science ◽

10.1017/cts.2017.158 ◽

2017 ◽

Vol 1 (S1) ◽

pp. 43-44

Author(s):

Carlton Hornung ◽

Carolyn Thomas Jones ◽

Terri Hinkley ◽

Vicki Ellingrod ◽

Nancy Calvin-Naylor

Keyword(s):

Clinical Research ◽

Data Management ◽

Core Competencies ◽

Safety Data ◽

The United States ◽

Education And Training ◽

Development Ethics ◽

The Impact ◽

And Training ◽

Research Professionals

OBJECTIVES/SPECIFIC AIMS: Clinical research in the 21st century will require a well-trained workforce to insure that research protocols yield valid and reliable results. Several organizations have developed lists of core competencies for clinical trial coordinators, administrators, monitors, data management/informaticians, regulatory affairs personnel, and others. While the Clinical Research Appraisal Inventory assesses the self-confidence of physician scientists to be clinical investigators, no such index exists to assess the competence of clinical research professionals who coordinate, monitor, and administer clinical trials. We developed the Competency Index for Clinical Research Professionals (CICRP) as a general index of competency (ie, GCPs) as well as sub-scales to assess competency in the specific domains of Medicines Development; Ethics and Participant Safety; Data Management; and Research Methods. METHODS/STUDY POPULATION: We analyzed data collected by the Joint Task Force on the Harmonization of Core Competencies from a survey of research professionals working in the United States and Canada. Respondents reported how competent they believed themselves to be on 51 clinical research core competencies. Factor analyzes identified 20 core competencies that defined a Competency Index for Clinical Research Professionals—General (CICRP-General, ie, GCPs) and 4 subindices that define specialized research functions: Medicines Development; Ethics and Participant Safety; Data Management; and Research Concepts. RESULTS/ANTICIPATED RESULTS: Factor analysis identified 20 core competencies that defined a Competency Index for Clinical Research Professionals—General (CICRP-General, ie, GCPs) and 4 subindices that define specialized research functions: Medicines Development; Ethics and Participant Safety; Data Management; and Research Concepts. DISCUSSION/SIGNIFICANCE OF IMPACT: These indices can be used to gage an individual’s readiness to perform general as well as more advanced research functions; to assess the education and training needs of research workers; and to evaluate the impact of education and training programs on the competency of research coordinators, monitors, and other clinical research team members.

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Leveling the Joint Task Force Core Competencies for Clinical Research Professionals

Therapeutic Innovation & Regulatory Science ◽

10.1007/s43441-019-00024-2 ◽

2020 ◽

Vol 54 (1) ◽

pp. 1-20 ◽

Cited By ~ 2

Author(s):

Stephen A. Sonstein ◽

Rebecca J. Namenek Brouwer ◽

William Gluck ◽

H. Robert Kolb ◽

Carmen Aldinger ◽

...

Keyword(s):

Clinical Research ◽

Task Force ◽

Core Competencies ◽

Joint Task ◽

Joint Task Force ◽

Research Professionals

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Longitudinal Experience With and Impressions of COVID-19–Related Clinical Research Changes

JCO Oncology Practice ◽

10.1200/op.21.00169 ◽

2021 ◽

pp. OP.21.00169

Author(s):

David E. Gerber ◽

Valerie L. Clark ◽

Thomas Y. Sheffield ◽

M. Shaalan Beg ◽

Yang Xie ◽

...

Keyword(s):

Clinical Research ◽

Personal Experience ◽

Research Personnel ◽

Global Pandemic ◽

Perceived Impact ◽

Office Personnel ◽

Research Professionals ◽

Study Monitoring ◽

Research Office

PURPOSE: The COVID-19 pandemic has led to profound changes in clinical research, including remote consent, telehealth, off-site procedures, shipment of therapy, and remote study monitoring. We assessed longitudinal perceptions of these adjustments among clinical research professionals. METHODS: We distributed an anonymous survey assessing experiences, perceptions, and recommendations regarding COVID-19–related clinical research adjustments to cancer clinical research office personnel in May 2020 and again in November 2020. Responses were compared using Fisher's exact and Mann-Whitney U tests. RESULTS: A total of 90 of 102 invited research personnel (88%) responded. Fifty-three (59%) reported participating in both initial and follow-up surveys. The proportion of respondents reporting personal experience with COVID-19–related adjustments increased over time, particularly for remote initial consent (29% v 4%), remote reconsent (24% v 9%), and remote study monitoring (36% v 22%). Perceived impact of COVID-19–related adjustments on data quality ( P = .02) and patient experience ( P = .002) improved significantly. However, perceived effect on patient safety ( P = .02) and respondent's experience ( P = .09) became less favorable. Individuals with personal experience with the adjustment were more likely to recommend continuing remote consent (62% v 38%; P = .04), remote monitoring (69% v 45%; P = .05), and therapy shipment (67% v 35%; P = .01) after the COVID-19 pandemic, with nonsignificant trends for off-site diagnostics (44% v 24%; P = .13) and telehealth visits (66% v 45%; P = .08). CONCLUSION: More than 6 months into the global pandemic, perceptions of COVID-19–related clinical research changes remain favorable. Experienced individuals are more likely to recommend that these changes continue in the future.

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