Establishing Good Clinical Practice Standards in the CTSA Program and Beyond

In response to the NIH Clinical Trial Working Group recommendation to standardize training, NCATS led a Clinical and Translational Science Awards (CTSA)-wide initiative to promote Good Clinical Practice (GCP) training for clinical trial personnel.  GCP is a process that incorporates established ethical and scientific quality standards for the design, conduct, recording and reporting of clinical research involving the participation of human subjects.  The projected was supported through supplemental grant funding to a CTSA Program network project entitled, “Enhancing Clinical Research Professionals’ Training and Qualifications” (3UL1TR000433-08S1).  The goals of the supplement were to (1) develop and implement standardized GCP training and (2) develop and implement a competency-based education curriculum for study teams across the CTSA consortium that equips a highly-qualified workforce with the necessary competencies to effectively, efficiently, and safely execute clinical trials.

 

View the ECRPTQ webpage here.

View the results of this work (PDF – 139KB).

Publications:  [Published in the Journal of Clinical and Translational Science link to journal home ]

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

Nancy A. Calvin-Naylor, Carolynn Thomas Jones, Michelle M. Wartak, Karen Blackwell, Jonathan M. Davis, Ruthvick Divecha, 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, Thomas P. Shanley

  1. Enhancing Clinical Research Professionals’ Training and Qualifications (ECRPTQ): Recommendations for Good Clinical Practice (GCP) training for investigators and study coordinators

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

 

Good Clinical Practice for Social and Behavioral Research – eLearning Course

Click here to access all of the modules.

The goal of this eLearning course is to enable learners to apply good clinical practice (GCP) principles to clinical research investigations involving human subjects as they specifically apply to social and behavioral research.

Audience:

Primary audience:

  • Principal investigators (PI)
  • Research Study Coordinators

Secondary audiences:

  • Community Partners
  • Students
  • Other team members conducting social and behavioral clinical research studies and clinical trials

The following list of eLearning Modules are to be downloaded by a technical representative of a university (etc) within their learning management systems (LMS).  Once the modules are uploaded into the LMS individuals from that Institution or University will be able to log in to their LMS and complete the course within the LMS.  Detailed technical instructions and documentation can be found at the bottom of this page.

 

Module 1: Introduction

The introductory module covers the importance of social and behavioral research best practices and introduces some common roles and responsibilities that people have within research teams. After completing this module, you will understand the International Conference on Harmonization’s (ICH) role in providing guidelines that are applied to social and behavioral research. You will also be familiar with ICH’s development of Good Clinical Practice (GCP) and how to interpret and apply it within the context of social and behavioral clinical trials.

Learning Objectives:

  • Define the role and context of ICH in providing guidelines for regulations
  • Show how ICH guidelines are applied to social and behavioral research
  • Define GCP
  • List the goals of GCP
  • Explain how GCP relates to the regulation of clinical trials in social and behavioral research
  • Compare the roles and responsibilities of the sponsor, institutional review board (IRB), research investigator, research coordinator, and other team members

Module 2: Research Protocol

This module discusses the elements of a social and behavioral research IRB protocol and standard operating procedures (SOPs). The concept of treatment fidelity is introduced, and strategies to minimize protocol deviations are discussed.

Learning Objectives:

  • Describe the elements of clinical and IRB protocols
  • Explain the importance of standard operating procedures (SOPs)
  • Explain and evaluate treatment fidelity
  • Recognize protocol deviations, identify strategies to minimize them and prevent re-occurrence, and list reporting requirements

Module 3: Recruitment and Retention

This module presents a few best practices for recruiting participants and keeping them enrolled and engaged in your study.

Learning Objectives:

  • Identify potential recruitment strategies and best practices for recruitment
  • Assure methods are appropriate for achieving adequate participation of populations under-represented in research
  • Identify potential strategies for participant retention

Module 4: Informed Consent Communication

This module identifies the required elements of informed consent, provides a set of tools to use to prepare for and conduct informed consent, as well as discusses special situations that may have different consent requirements, such as children.

Learning Objectives:

  • Outline the Informed Consent process
  • List the required elements of informed consent process per GCP guidelines
  • Identify key aspects of communication strategies for the consent process to ensure participants’ (including vulnerable participants’) rights, safety, and well-being are prioritized
  • Critique informed consent communication between a study team member and participant to determine areas for improvement

Module 5: Confidentiality and Privacy

This module defines privacy and confidentiality, provides strategies to protect participants’ privacy and confidentiality, and discusses how to identify and report breaches in privacy and confidentiality.

Learning Objectives:

  • Differentiate concepts of confidentiality and privacy
  • Select strategies to ensure data are collected and managed in ways that assure participant confidentiality and privacy
  • Identify instances when confidentiality or privacy are compromised
  • Identify when and to whom reporting is necessary

Module 6: Participant Safety and AE Reporting

This module discusses how to identify, record, and report adverse events in social and behavioral research studies.

Learning Objectives:

  • Develop communication strategies for detecting adverse events that can be used by the entire study team
  • Develop common strategies for reporting adverse events
  • Define the role and responsibilities of a data safety and monitoring board in a behavioral clinical trial

Module 7: Quality Control and Assurance

This module discusses the importance of quality control and assurance in social and behavioral research studies. The module also discusses the importance of identifying potential bias and implementing strategies geared toward upholding data integrity.

Learning Objectives:

  • Explain the importance of quality control/assurance in a clinical trial
  • Select strategies that can help systematically monitor participant progress through a study, including identifying incomplete/missing and out-of-range data
  • Identify sources of bias that can affect data quality
  • Assess how different biases can affect data quality using a case-based example

Module 8: Research Misconduct

This module offers examples and behaviors to watch for, as well as three steps to recognize and report misconduct in a research setting.

  • Define research misconduct
  • Identify behavior that constitutes misconduct
  • Describe the process for reporting an instance of misconduct
  • Explain the consequences of research misconduct

Module 9: Conclusion/wrap-up

This module revisits key ideas learned throughout the modules, as well as resources and job aids that learners can utilize while conducting social and behavioral research.

Technical Instructions and documentation for the Social and Behavioral Research Best Practices for Clinical Research course series

These modules were published with Articulate Storyline 2 Update 9 – Build 1605.1919 (released 5/23/2016) in June 2016

 

These modules are published for the following completion/tracking:

SCORM 1.2

Passed/Incomplete

Completion marked on 100% passing of final assessment (exception for Conclusion module, which marks completion based on viewing all screens within module)

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