Research nurse manager perceptions about research activities performed by non-nurse clinical research coordinators

2015 ◽  
Vol 63 (4) ◽  
pp. 474-483 ◽  
Author(s):  
Carolynn Thomas Jones ◽  
Clare Hastings ◽  
Lynda Law Wilson
Author(s):  
Elizabeth Biswell R ◽  
Michael Clark ◽  
Michela Tinelli ◽  
Gillian Manthorpe ◽  
Joanne Neale ◽  
...  

2021 ◽  
Vol 12 (02) ◽  
pp. 293-300
Author(s):  
Kevin S. Naceanceno ◽  
Stacey L. House ◽  
Phillip V. Asaro

Abstract Background Clinical trials performed in our emergency department at Barnes-Jewish Hospital utilize a centralized infrastructure for alerting, screening, and enrollment with rule-based alerts sent to clinical research coordinators. Previously, all alerts were delivered as text messages via dedicated cellular phones. As the number of ongoing clinical trials increased, the volume of alerts grew to an unmanageable level. Therefore, we have changed our primary notification delivery method to study-specific, shared-task worklists integrated with our pre-existing web-based screening documentation system. Objective To evaluate the effects on screening and recruitment workflow of replacing text-message delivery of clinical trial alerts with study-specific shared-task worklists in a high-volume academic emergency department supporting multiple concurrent clinical trials. Methods We analyzed retrospective data on alerting, screening, and enrollment for 10 active clinical trials pre- and postimplementation of shared-task worklists. Results Notifications signaling the presence of potentially eligible subjects for clinical trials were more likely to result in a screen (p < 0.001) with the implementation of shared-task worklists compared with notifications delivered as text messages for 8/10 clinical trials. The change in workflow did not alter the likelihood of a notification resulting in an enrollment (p = 0.473). The Director of Research reported a substantial reduction in the amount of time spent redirecting clinical research coordinator screening activities. Conclusion Shared-task worklists, with the functionalities we have described, offer a viable alternative to delivery of clinical trial alerts via text message directly to clinical research coordinators recruiting for multiple concurrent clinical trials in a high-volume academic emergency department.


2007 ◽  
Vol 4 (1) ◽  
pp. 10-13 ◽  
Author(s):  
P Chester ◽  
ED Kennedy ◽  
S Hynd ◽  
DR Matthews

2015 ◽  
Vol 2015 ◽  
pp. 1-10 ◽  
Author(s):  
A. Anil Sinaci ◽  
Gokce B. Laleci Erturkmen ◽  
Suat Gonul ◽  
Mustafa Yuksel ◽  
Paolo Invernizzi ◽  
...  

Postmarketing drug surveillance is a crucial aspect of the clinical research activities in pharmacovigilance and pharmacoepidemiology. Successful utilization of available Electronic Health Record (EHR) data can complement and strengthen postmarketing safety studies. In terms of the secondary use of EHRs, access and analysis of patient data across different domains are a critical factor; we address this data interoperability problem between EHR systems and clinical research systems in this paper. We demonstrate that this problem can be solved in an upper level with the use of common data elements in a standardized fashion so that clinical researchers can work with different EHR systems independently of the underlying information model. Postmarketing Safety Study Tool lets the clinical researchers extract data from different EHR systems by designing data collection set schemas through common data elements. The tool interacts with a semantic metadata registry through IHE data element exchange profile. Postmarketing Safety Study Tool and its supporting components have been implemented and deployed on the central data warehouse of the Lombardy region, Italy, which contains anonymized records of about 16 million patients with over 10-year longitudinal data on average. Clinical researchers in Roche validate the tool with real life use cases.


2016 ◽  
Vol 27 ◽  
pp. iv111 ◽  
Author(s):  
C. Cagnazzo ◽  
O. Nanni ◽  
S. Campora ◽  
P. Frati ◽  
R. Camisa ◽  
...  

2017 ◽  
Vol 1 (1) ◽  
pp. 16-25 ◽  
Author(s):  
Nancy A. Calvin-Naylor ◽  
Carolynn Thomas Jones ◽  
Michelle M. Wartak ◽  
Karen Blackwell ◽  
Jonathan M. Davis ◽  
...  

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.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
L. Lee Dupuis ◽  
Allison Grimes ◽  
Emily Vettese ◽  
Lisa M. Klesges ◽  
Lillian Sung

Abstract Background Objectives were to describe barriers to pediatric cancer symptom management care pathway implementation and the impact of the COVID-19 pandemic on clinical research evaluating their implementation. Methods We included 25 pediatric oncology hospitals in the United States that supported a grant submission to perform a cluster randomized trial in which the intervention encompassed care pathways for symptom management. A survey was distributed to site principal investigators prior to randomization to measure contextual elements related to care pathway implementation. Questions included the inner setting measures of the Consolidated Framework for Implementation Research (CFIR), study-specific potential barriers and the impact of the COVID-19 pandemic on clinical research. The Wilcoxon rank sum test was used to compare characteristics of institutions that agreed that their department supported the implementation of symptom management care pathways vs. institutions that did not agree. Results Of the 25 sites, one withdrew because of resource constraints and one did not respond, leaving 23 institutions. Among the seven CFIR constructs, the least supported was implementation climate; 57% agreed there was support, 39% agreed there was recognition and 39% agreed there was prioritization for symptom management care pathway implementation at their institution. Most common barriers were lack of person-time to create care pathways and champion their use (35%), lack of interest from physicians (30%) and lack of information technology resources (26%). Most sites reported no negative impact of the COVID-19 pandemic across research activities. Sites with fewer pediatric cancer patients were more likely to agree that staff are supported to implement symptom management care pathways (P = 0.003). Conclusions The most commonly reported barriers to implementation were lack of support, recognition and prioritization. The COVID-19 pandemic may not be a major barrier to clinical research activities in pediatric oncology.


1985 ◽  
Vol 3 (1) ◽  
pp. 125-137
Author(s):  
Priscilla M. Brady ◽  
Jane E. McCue ◽  
Joseph S. Alpert

Author(s):  
Garrett K Berger ◽  
John C Neilson ◽  
David M King ◽  
Adam N Wooldridge

Aim: To describe the efficacy of clinical research coordinators (CRCs) in terms of research output among faculty, residents and medical students. Materials & methods: We analyzed and reviewed departmental research output from the 3 years prior to the hire of 3 CRCs compared with the 3 years following. Results: From 2014 to 2016, the department output was a total of 27 peer-reviewed publications, 16 oral presentations and 33 poster presentations. From 2017–2019 there was a 52% increase in publications (n = 41), 131% increase in oral presentations (n = 37) and a 61% increase in poster presentations (n = 53). Conclusion: The implementation of CRCs has markedly increased tangible research output and trainee involvement. This role may serve as a valuable model for other academic departments.


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