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GCP SBR Advanced Refresher

Provides retraining on GCP principles suitable for social and behavioral investigators and staff.

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About this Course


GCP SBR Advanced Refresher reinforces the importance of concepts covered in the basic level GCP – Social and Behavioral Research Best Practices for Clinical Research course. This second-level course goes in-depth on more advanced GCP concepts (for example, specific GCP issues like monitoring, audits, inspections, and data and safety monitoring), expands upon the breadth of the investigator’s responsibilities, and explores topics relevant to social sciences research and behavioral trials not traditionally covered in GCP courses (such as when social behavioral research could be considered a clinical trial, social media use in research, and deception in informed consent).

The course may be considered acceptable training by the National Institutes of Health (NIH) in fulfillment of their GCP training policy (Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials; NOT-OD-16-148) that says NIH-funded investigators and staff should be trained in GCP.

This course also meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors when the following modules are completed:

  • Overview of ICH E6 GCP for Behavioral Interventions and Social Science Research
  • Investigator’s Role and Responsibilities in Behavioral Interventions and Social Science Research
  • Informed Consent in Behavioral Interventions and Social Science Research
  • Monitoring, Audits, Inspections, and Data and Safety Monitoring of Behavioral Interventions and Social Science Research
  • In-Depth Review of ICH E6 and TransCelerate Minimum Requirements

Content in the GCP SBR Advanced Refresher is up to date with ICH E6(R2).

Language Availability: English

Suggested Audiences: Social and behavioral investigators and staff

Organizational Subscription Price: Included in organizational subscription
Independent Learner Price: $129 per person


Course Content


When a Social and Behavioral Research Study May be Considered a Clinical Trial New Content

Provides an overview of the various definitions of “clinical trial” from regulatory agencies and organizations, including the implications for researchers. Identifies the key traits of the NIH definition of clinical trial and its applicability to social and behavioral research.

Recommended Use: Required
ID (Language): 17652 (English)
Author(s): Ayn Embar-Seddon O'Reilly, PhD, CIP - Capella University

Overview of ICH E6 GCP for Behavioral Interventions and Social Science Research New Content

Explains the purpose and basic requirements of ICH E6 as applicable to behavioral interventions and social science research. Examines GCP principles that are relevant to behavioral interventions and social science research.

Recommended Use: Required
ID (Language): 17653 (English)
Author(s): Cynthia J. Monahan, MBA, CIP - Boston University

Investigator's Role and Responsibilities in Behavioral Interventions and Social Science Research New Content

Discusses the investigator’s role and responsibilities for behavioral interventions and social science research according to GCP principles, potential pitfalls and areas of noncompliance, and requirements for reporting research results and adverse events. Defines sponsor and sponsor-investigator roles. Reviews special considerations for faculty supervising students as investigators and mandated reporting requirements.

Recommended Use: Required
ID (Language): 17654 (English)
Author(s): Amy West, PhD - University of Southern California; Sally Weinstein, PhD - University of Illinois at Chicago

Informed Consent in Behavioral Interventions and Social Science Research New Content

Describes the process for obtaining and documenting informed consent according to GCP guidelines and regulatory requirements. Explores consent issues in research with deception or incomplete disclosure.

Recommended Use: Required
ID (Language): 17655 (English)
Author(s): Amy West, PhD - University of Southern California

Monitoring, Audits, Inspections, and Data and Safety Monitoring of Behavioral Interventions and Social Science Research New Content

Identifies the oversight activities and responsibilities for monitoring visits, audits, inspections, and data and safety monitoring in accordance with ICH E6 in social and behavioral research.

Recommended Use: Required
ID (Language): 17656 (English)
Author(s): Cynthia J. Monahan, MBA, CIP - Boston University


Additional Modules of Interest


Methods and Risks in Behavioral Interventions and Social Science Research New Content

Examines potential risks of harm from commonly used methods in behavioral interventions and social science research, and discusses strategies to identify and reduce potential risks of harm.

Recommended Use: Supplemental
ID (Language): 17657 (English)
Author(s): Cynthia J. Monahan, MBA, CIP - Boston University

Social Media in Behavioral Interventions and Social Science Research New Content

Defines and gives examples of social and digital media in research and discusses regulatory agency and committee guidance. Presents potential benefits and challenges of using social media in clinical trials and discusses how to manage risks of harm, maintain subject privacy, and protect data security.

Recommended Use: Supplemental
ID (Language): 17658 (English)
Author(s): Ayn Embar-Seddon O'Reilly, PhD, CIP - Cappella University

In-Depth Review of ICH E6 and TransCelerate Minimum Requirements New Content

Fulfills mutual recognition training requirements for the course by reviewing the remaining topics from the ICH E6 guideline not previously covered in this course and required by TransCelerate BioPharma for investigator site personnel training. Defines GCP terms relating to drug and biologic research, identifies the 13 principles of ICH GCP, and explains the investigator role in clinical trials of investigational products. Applies the GCP principles to social sciences research and behavioral trials.

Recommended Use: Supplemental
ID (Language): 17659 (English)
Author(s): Ayn Embar-Seddon O'Reilly, PhD, CIP - Cappella University