Tags

Type your tag names separated by a space and hit enter

Enhancing Clinical Research Professionals' Training and Qualifications (ECRPTQ): Recommendations for Good Clinical Practice (GCP) training for investigators and study coordinators.
J Clin Transl Sci. 2017 Feb; 1(1):8-15.JC

Abstract

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.

Authors+Show Affiliations

Department of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.Institute for Research on Innovation and Science (IRIS), University of Michigan, Ann Arbor, MI, USA.Medical Affairs, University of Michigan, Ann Arbor, MI, USA.Broad Institute of MIT, Boston, MA, USA.Human Research Protection Program, University of Kansas, Kansas City, KS, USA.Frontiers: The Heartland Institute for Clinical and Translational Science, Fairway, MA, USA.Department of Preventive Medicine and Public Health, University of Kansas, Kansas City, KS, USA.Clinical and Translational Science Institute, University of Rochester, Rochester, NY, USA.UMass Center for Clinical and Translational Science, University of Massachusetts, Lowell, MA, USA.UMass Center for Clinical and Translational Science, University of Massachusetts, Lowell, MA, USA.Frontiers: The Heartland Institute for Clinical and Translational Science, Fairway, MA, USA.Clinical and Translational Science Institute, University of Rochester, Rochester, NY, USA.Michigan Institute for Clinical & Health Research, University of Michigan, Ann Arbor, MI, USA.Frontiers: The Heartland Institute for Clinical and Translational Science, Fairway, MA, USA.Michigan Institute for Clinical & Health Research, University of Michigan, Ann Arbor, MI, USA.Clinical and Translational Science Institute, University of Rochester, Rochester, NY, USA.Clinical and Translational Science Institute, Tufts University, Boston, MA, USA.Clinical Trials Transformation Initiative, Durham, NC, USA.Human Subject Protection Program, University of Rochester, Rochester, NY, USA.Michigan Institute for Clinical & Health Research, University of Michigan, Ann Arbor, MI, USA.Clinical and Translational Science Institute, University of Miami, Miami, FL, USA.Frontiers: The Heartland Institute for Clinical and Translational Science, Fairway, MA, USA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31660210

Citation

Shanley, Thomas P., et al. "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, vol. 1, no. 1, 2017, pp. 8-15.
Shanley TP, Calvin-Naylor NA, Divecha R, et al. Enhancing Clinical Research Professionals' Training and Qualifications (ECRPTQ): Recommendations for Good Clinical Practice (GCP) training for investigators and study coordinators. J Clin Transl Sci. 2017;1(1):8-15.
Shanley, T. P., Calvin-Naylor, N. A., Divecha, R., Wartak, M. M., Blackwell, K., Davis, J. M., Ellerbeck, E. F., Kieburtz, K., Koziel, M. J., Luzuriaga, K., Maddox, J., Needler, N. A., Murphy, S., Pemberton, K., Radovich, C., Rubinstein, E. P., Selker, H. P., Tenaerts, P., Unsworth, K., ... Barohn, R. (2017). 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, 1(1), 8-15. https://doi.org/10.1017/cts.2016.1
Shanley TP, et al. Enhancing Clinical Research Professionals' Training and Qualifications (ECRPTQ): Recommendations for Good Clinical Practice (GCP) Training for Investigators and Study Coordinators. J Clin Transl Sci. 2017;1(1):8-15. PubMed PMID: 31660210.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Enhancing Clinical Research Professionals' Training and Qualifications (ECRPTQ): Recommendations for Good Clinical Practice (GCP) training for investigators and study coordinators. AU - Shanley,Thomas P, AU - Calvin-Naylor,Nancy A, AU - Divecha,Ruthvick, AU - Wartak,Michelle M, AU - Blackwell,Karen, AU - Davis,Jonathan M, AU - Ellerbeck,Edward F, AU - Kieburtz,Karl, AU - Koziel,Margaret J, AU - Luzuriaga,Katherine, AU - Maddox,Jennifer, AU - Needler,Nancy A, AU - Murphy,Susan, AU - Pemberton,Kieran, AU - Radovich,Catherine, AU - Rubinstein,Eric P, AU - Selker,Harry P, AU - Tenaerts,Pamela, AU - Unsworth,Kelly, AU - Wilson,Kay, AU - Wright,Jonelle E, AU - Barohn,Richard, Y1 - 2017/01/13/ PY - 2016/05/10/received PY - 2016/07/27/accepted PY - 2019/10/30/entrez PY - 2017/1/13/pubmed PY - 2017/1/13/medline KW - CTSA KW - Clinical research training KW - Good Clinical Practice (GCP) SP - 8 EP - 15 JF - Journal of clinical and translational science JO - J Clin Transl Sci VL - 1 IS - 1 N2 - 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. SN - 2059-8661 UR - https://www.unboundmedicine.com/medline/citation/31660210/Enhancing_Clinical_Research_Professionals'_Training_and_Qualifications__ECRPTQ_:_Recommendations_for_Good_Clinical_Practice__GCP__training_for_investigators_and_study_coordinators_ L2 - https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/31660210/ DB - PRIME DP - Unbound Medicine ER -
Try the Free App:
Prime PubMed app for iOS iPhone iPad
Prime PubMed app for Android
Prime PubMed is provided
free to individuals by:
Unbound Medicine.