Good Clinical Practice for Social and Behavioral Research – eLearning Course
In September 2016, the NIH issued a Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html). Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials. The principles of GCP help assure the safety, integrity, and quality of clinical trials. Investigators and clinical trial staff who are competent in GCP principles will be better able to assure that the rights, safety and well-being of human subjects are protected; that clinical trials are conducted in accordance with approved plans and with rigor and integrity, and that data derived from clinical trials are reliable.
The National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), through the Clinical and Translational Science Awards (CTSA) Program initiated a project in 2014 to streamline and standardize GCP training for clinical study personnel, including researchers conducting clinical trials. Ample GCP training exists for investigators conducting drug-, device-, or biologic-related studies, but it does not address clinical trials using behavioral interventions and social science research.
The CTSA Program project team recognized a critical need for training in applying GCP principles to social and behavioral research and thus developed the Best Practices in Social and Behavioral Research e-Learning Course for GCP to fill the gap. In 2016, the Best Practices in Social and Behavioral Research Course e-Learning Course for GCP was released to provide researchers with training that applies GCP principles to social and behavioral research.
The e-Learning course is comprised of nine video course modules. These courses are specifically developed to run in a Learning Management System (LMS), which is typically centrally managed at an institution. Contact your institution's Learning Management System Information Technology (IT) or general IT group in order to upload and add these files to your institution’s LMS. These files are SCORM 1.2 compliant packages that were created in Articulate Storyline 2. The modules cannot be viewed or used on a personal computer without a LMS.
Take the course here or scroll to the bottom of the page for instructions on downloading and uploading the modules to your LMS.
All nine modules must be viewed and completed within an institution’s Learning Management System. The LMS should create a certificate of completion for the learner upon successful completion of the modules. Successful completion requires the learner to work through all nine module and successfully complete the knowledge tests and exercises along the way. The course is designed to track progress within your Institution’s LMS, and offers an option to print or save a certificate of completion from you institution’s LMS.
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Researchers at select CTSA Program-funded universities are conducting an evaluation of the Best Practices in Social and Behavioral Research e-Learning Course for GCP. If your institution is interested in learning more about the design of this course or its evaluation, please email email@example.com for details.
The development of the Best Practices in Social and Behavioral Research e-Learning Course for GCP was supported by the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), through the Clinical and Translational Science Awards (CTSA) Program, grant number 3UL1TR000433.”
All nine modules must be downloaded, and set up within an institution’s Learning Management System.
The LMS should create a certificate of completion for the learner upon successful completion of the modules. Successful completion requires the learner to work through all nine module and successfully complete the knowledge tests and exercises along the way. The course is designed to track progress within your Institution’s LMS, and offers an option to print or save a certificate of completion from you institution’s LMS.
Module 1: Introduction - Download zip file 35 MB
Module 2: Research Protocol - Download zip file 111 MB
Module 3: Recruitment and Retention - Download zip file 102 MB
Module 4: Informed Consent Communication - Download zip file 181 MB
Module 5: Confidentiality and Privacy - Download zip file 76 MB
Module 6: Participant Safety and AE Reporting - Download zip file 101 MB
Module 7: Quality Control and Assurance - Download zip file 112 MB
Module 8: Research Misconduct - Download zip file 141 MB
Module 9: Conclusion/wrap-up - Download zip file 18 MB