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GCP – Social and Behavioral Research Best Practices for Clinical Research

This course is suitable for social and behavioral investigators and staff who must be trained in GCP.


About this Course


The GCP – Social and Behavioral Research Best Practices for Clinical Research course introduces GCP principles and discusses how they apply to clinical trials using behavioral interventions and social science research. This course is presented in a dynamic, nine-module format with narration, interactive features, and downloadable resources.

It covers key topics in clinical research:

  • Research Protocol
  • Recruitment and Retention
  • Informed Consent Communication
  • Confidentiality and Privacy
  • Participant Safety and Adverse Event Reporting
  • Quality Control and Assurance
  • Research Misconduct

The National Institutes of Health’s (NIH) “Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials” establishes the expectation that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in GCP. This course helps behavioral and social science researchers meet that expectation.

The development of the GCP – Social and Behavioral Research Best Practices for Clinical Research course 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.

Language Availability: English

Suggested Audiences: IRB Members, Clinical Research Coordinators, Clinical Research Organizations (CROs), Researchers, Investigators, Key Study Personnel, Principal Investigators, Research Nurses, Research Staff, Sponsors, Study Coordinators

Organizational Subscription Price: Included in organizational subscription
Independent Learner Price: Coming Soon


CE Credits and Units


Physicians

AMA PRA Category 1 Credit

3 Credits
(6 CE certified modules)
$60

1 August 2017
31 July 2020

Psychologists

CE Credit/Hour

3 Credits
(6 CE certified modules)
$60

1 August 2017
31 July 2020

Other Participants

Certificate of Participation

3 Credits
(6 CE certified modules)
$50

1 August 2017
31 July 2017


Course Content


Toggle Content Introduction New/Updated Badge

Covers the importance of social and behavioral research best practices, and introduces common roles within research teams. Introduces GCP principles and reviews the definition of clinical trials in the context of social and behavioral research.

Recommended Use: Required
ID (Language): 17531 (English)

Toggle Content Research Protocol CME/CEU Badge New/Updated Badge

Discusses the elements of a social and behavioral research Institutional Review Board (IRB) protocol and standard operating procedures (SOPs). Introduces the concept of treatment fidelity and discusses strategies to minimize protocol deviations.

Recommended Use: Required
ID (Language): 17532 (English)

Toggle Content Recruitment and Retention CME/CEU Badge New/Updated Badge

Presents a number of best practices for recruiting participants, and keeping them enrolled and engaged in the study.

Recommended Use: Required
ID (Language): 17533 (English)

Toggle Content Informed Consent Communication CME/CEU Badge New/Updated Badge

Identifies the required elements of informed consent, provides a set of tools to use to prepare for and conduct informed consent, and discusses special situations that may have different consent requirements (such as, research involving children). Describes the purpose of the informed consent document and strategies to obtain consent.

Recommended Use: Required
ID (Language): 17534 (English)

Toggle Content Privacy and Confidentiality CME/CEU Badge New/Updated Badge

Defines privacy and confidentiality, provides strategies to protect participant privacy and confidentiality, and discusses how to identify and report breaches in privacy and confidentiality.

Recommended Use: Required
ID (Language): 17535 (English)

Toggle Content Participant Safety and Adverse Event Reporting CME/CEU Badge New/Updated Badge

Identifies adverse events and describes how to record and report them. Provides strategies for defining adverse events for a study and developing an adverse event reporting plan.

Recommended Use: Required
ID (Language): 17536 (English)

Toggle Content Quality Control and Assurance CME/CEU Badge New/Updated Badge

Explains the basics and importance of good quality control throughout the course of a study. Discusses the importance of identifying potential bias and implementing strategies geared toward upholding data integrity.

Recommended Use: Required
ID (Language): 17537 (English)

Toggle Content Research Misconduct CME/CEU Badge New/Updated Badge

Discusses research misconduct and reporting requirements. Illustrates misconduct through examples and consequences of misconduct. Reviews steps for reporting misconduct.

Recommended Use: Required
ID (Language): 17538 (English)

Toggle Content Conclusion New/Updated Badge

Revisits key ideas learned throughout the modules, as well as resources and job aids that learners may utilize while conducting social and behavioral research.

Recommended Use: Required
ID (Language): 17539 (English)