Enhancing Clinical Research Professionals’ Training and Qualifications (ECRPTQ): Recommendations for Good Clinical Practice (GCP) training for investigators and study coordinators
Introduction The translation of discoveries to drugs, devices, and behavioral interventions requires well-prepared study teams. Execution of clinical trials remains suboptimal due to varied quality in design, execution, analysis, and reporting. A critical...
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| Format: | Article |
| Language: | English |
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Cambridge University Press
2017-02-01
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| Series: | Journal of Clinical and Translational Science |
| Subjects: | |
| Online Access: | https://www.cambridge.org/core/product/identifier/S2059866116000017/type/journal_article |
| _version_ | 1811156841634201600 |
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| author | Thomas P. Shanley Nancy A. Calvin-Naylor Ruthvick Divecha Michelle M. Wartak Karen Blackwell Jonathan M. Davis Edward F. Ellerbeck Karl Kieburtz Margaret J. Koziel Katherine Luzuriaga Jennifer Maddox Nancy A. Needler Susan Murphy Kieran Pemberton Catherine Radovich Eric P. Rubinstein Harry P. Selker Pamela Tenaerts Kelly Unsworth Kay Wilson Jonelle E. Wright Richard Barohn |
| author_facet | Thomas P. Shanley Nancy A. Calvin-Naylor Ruthvick Divecha Michelle M. Wartak Karen Blackwell Jonathan M. Davis Edward F. Ellerbeck Karl Kieburtz Margaret J. Koziel Katherine Luzuriaga Jennifer Maddox Nancy A. Needler Susan Murphy Kieran Pemberton Catherine Radovich Eric P. Rubinstein Harry P. Selker Pamela Tenaerts Kelly Unsworth Kay Wilson Jonelle E. Wright Richard Barohn |
| author_sort | Thomas P. Shanley |
| collection | DOAJ |
| description |
Introduction
The translation of discoveries to drugs, devices, and behavioral interventions requires well-prepared study teams. Execution of clinical trials remains suboptimal due to varied quality in design, execution, analysis, and reporting. A critical impediment is inconsistent, or even absent, competency-based training for clinical trial personnel.
Methods
In 2014, the National Center for Advancing Translational Science (NCATS) funded the project, Enhancing Clinical Research Professionals’ Training and Qualifications (ECRPTQ), aimed at addressing this deficit. The goal was to ensure all personnel are competent to execute clinical trials. A phased structure was utilized.
Results
This paper focuses on training recommendations in Good Clinical Practice (GCP). Leveraging input from all Clinical and Translational Science Award hubs, the following was recommended to NCATS: all investigators and study coordinators executing a clinical trial should understand GCP principles and undergo training every 3 years, with the training method meeting the minimum criteria identified by the International Conference on Harmonisation GCP.
Conclusions
We anticipate that industry sponsors will acknowledge such training, eliminating redundant training requests. We proposed metrics to be tracked that required further study. A separate task force was composed to define recommendations for metrics to be reported to NCATS.
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| first_indexed | 2024-04-10T04:57:51Z |
| format | Article |
| id | doaj.art-36478c92f6344be3ad375e74d91b3a19 |
| institution | Directory Open Access Journal |
| issn | 2059-8661 |
| language | English |
| last_indexed | 2024-04-10T04:57:51Z |
| publishDate | 2017-02-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | Journal of Clinical and Translational Science |
| spelling | doaj.art-36478c92f6344be3ad375e74d91b3a192023-03-09T12:29:30ZengCambridge University PressJournal of Clinical and Translational Science2059-86612017-02-01181510.1017/cts.2016.1Enhancing Clinical Research Professionals’ Training and Qualifications (ECRPTQ): Recommendations for Good Clinical Practice (GCP) training for investigators and study coordinatorsThomas P. Shanley0Nancy A. Calvin-Naylor1Ruthvick Divecha2Michelle M. Wartak3Karen Blackwell4Jonathan M. Davis5Edward F. Ellerbeck6Karl Kieburtz7Margaret J. Koziel8Katherine Luzuriaga9Jennifer Maddox10Nancy A. Needler11Susan Murphy12Kieran Pemberton13Catherine Radovich14Eric P. Rubinstein15Harry P. Selker16Pamela Tenaerts17Kelly Unsworth18Kay Wilson19Jonelle E. Wright20Richard Barohn21Department of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USAInstitute for Research on Innovation and Science (IRIS), University of Michigan, Ann Arbor, MI, USAMedical Affairs, University of Michigan, Ann Arbor, MI, USABroad Institute of MIT, Boston, MA, USAHuman Research Protection Program, University of Kansas, Kansas City, KS, USAFrontiers: The Heartland Institute for Clinical and Translational Science, Fairway, MA, USADepartment of Preventive Medicine and Public Health, University of Kansas, Kansas City, KS, USAClinical and Translational Science Institute, University of Rochester, Rochester, NY, USAUMass Center for Clinical and Translational Science, University of Massachusetts, Lowell, MA, USAUMass Center for Clinical and Translational Science, University of Massachusetts, Lowell, MA, USAFrontiers: The Heartland Institute for Clinical and Translational Science, Fairway, MA, USAClinical and Translational Science Institute, University of Rochester, Rochester, NY, USAMichigan Institute for Clinical & Health Research, University of Michigan, Ann Arbor, MI, USAFrontiers: The Heartland Institute for Clinical and Translational Science, Fairway, MA, USAMichigan Institute for Clinical & Health Research, University of Michigan, Ann Arbor, MI, USAClinical and Translational Science Institute, University of Rochester, Rochester, NY, USAClinical and Translational Science Institute, Tufts University, Boston, MA, USAClinical Trials Transformation Initiative, Durham, NC, USAHuman Subject Protection Program, University of Rochester, Rochester, NY, USAMichigan Institute for Clinical & Health Research, University of Michigan, Ann Arbor, MI, USAClinical and Translational Science Institute, University of Miami, Miami, FL, USAFrontiers: The Heartland Institute for Clinical and Translational Science, Fairway, MA, USA Introduction The translation of discoveries to drugs, devices, and behavioral interventions requires well-prepared study teams. Execution of clinical trials remains suboptimal due to varied quality in design, execution, analysis, and reporting. A critical impediment is inconsistent, or even absent, competency-based training for clinical trial personnel. Methods In 2014, the National Center for Advancing Translational Science (NCATS) funded the project, Enhancing Clinical Research Professionals’ Training and Qualifications (ECRPTQ), aimed at addressing this deficit. The goal was to ensure all personnel are competent to execute clinical trials. A phased structure was utilized. Results This paper focuses on training recommendations in Good Clinical Practice (GCP). Leveraging input from all Clinical and Translational Science Award hubs, the following was recommended to NCATS: all investigators and study coordinators executing a clinical trial should understand GCP principles and undergo training every 3 years, with the training method meeting the minimum criteria identified by the International Conference on Harmonisation GCP. Conclusions We anticipate that industry sponsors will acknowledge such training, eliminating redundant training requests. We proposed metrics to be tracked that required further study. A separate task force was composed to define recommendations for metrics to be reported to NCATS. https://www.cambridge.org/core/product/identifier/S2059866116000017/type/journal_articleClinical research trainingGood Clinical Practice (GCP)CTSA |
| spellingShingle | Thomas P. Shanley Nancy A. Calvin-Naylor Ruthvick Divecha Michelle M. Wartak Karen Blackwell Jonathan M. Davis Edward F. Ellerbeck Karl Kieburtz Margaret J. Koziel Katherine Luzuriaga Jennifer Maddox Nancy A. Needler Susan Murphy Kieran Pemberton Catherine Radovich Eric P. Rubinstein Harry P. Selker Pamela Tenaerts Kelly Unsworth Kay Wilson Jonelle E. Wright Richard Barohn Enhancing Clinical Research Professionals’ Training and Qualifications (ECRPTQ): Recommendations for Good Clinical Practice (GCP) training for investigators and study coordinators Journal of Clinical and Translational Science Clinical research training Good Clinical Practice (GCP) CTSA |
| title | Enhancing Clinical Research Professionals’ Training and Qualifications (ECRPTQ): Recommendations for Good Clinical Practice (GCP) training for investigators and study coordinators |
| title_full | Enhancing Clinical Research Professionals’ Training and Qualifications (ECRPTQ): Recommendations for Good Clinical Practice (GCP) training for investigators and study coordinators |
| title_fullStr | Enhancing Clinical Research Professionals’ Training and Qualifications (ECRPTQ): Recommendations for Good Clinical Practice (GCP) training for investigators and study coordinators |
| title_full_unstemmed | Enhancing Clinical Research Professionals’ Training and Qualifications (ECRPTQ): Recommendations for Good Clinical Practice (GCP) training for investigators and study coordinators |
| title_short | Enhancing Clinical Research Professionals’ Training and Qualifications (ECRPTQ): Recommendations for Good Clinical Practice (GCP) training for investigators and study coordinators |
| title_sort | enhancing clinical research professionals training and qualifications ecrptq recommendations for good clinical practice gcp training for investigators and study coordinators |
| topic | Clinical research training Good Clinical Practice (GCP) CTSA |
| url | https://www.cambridge.org/core/product/identifier/S2059866116000017/type/journal_article |
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