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Clara Fargo
EBMT Clinical Research Quality Assurance Coordinator
I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...
Social & Behavioral Research Best Practices for Clinical Research Course & Certification
Intermediate
4.7
★★★★★
97% Recommended
Updated 2026
3 hour
95 active users
2 points
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About
The Social & Behavioral Research Best Practices for Clinical Research Course is designed to provide a comprehensive understanding of ethical, scientific, and regulatory considerations in social and behavioral research conducted within clinical settings. The course focuses on ensuring participant protection, data quality, and compliance with research standards.
This course covers study design principles, informed consent, privacy and confidentiality, participant recruitment, risk assessment, data collection methods, ethical considerations, and regulatory requirements. Upon successful completion, learners receive a certification demonstrating competency in social and behavioral research best practices.
Who Should Enrol?
- Clinical Research Professionals
- Researchers and Study Coordinators
- Clinical Trial Managers and Coordinators
- Principal Investigators and Research Staff
- Regulatory Affairs and Compliance Professionals
- Public Health and Behavioral Science Professionals
- Pharmaceutical, Biotechnology, and CRO Employees
- Life Science, Pharmacy, Nursing, Medical, and Social Science Graduates
What you will learn
Understand the evolving regulatory landscape of Social & Behavioral Research (SBR), including when studies are classified as clinical trials and key ethical and compliance considerations.
Learn how ICH E6(R3) principles apply to behavioural research, including Quality by Design, proportionality, data integrity, and risk-based monitoring approaches.
Gain knowledge of advanced informed consent practices in SBR, including deception, waiver of consent, debriefing, eConsent, and ethical considerations in vulnerable populations.
Develop an understanding of safety monitoring, digital recruitment ethics, and modern quality systems in SBR, including DSMBs, adverse event handling, social media recruitment, and audit readiness.
Course Syllabus
- The New Regulatory Threshold for SBR
- The NIH Definition of a Clinical Trial
- Delta Content: The BESH Shift (2026)
- Identifying the 'Intervention' in SBR
- Defining 'Health-Related Outcomes'
- The 'Prospective Assignment' Nuance
- Risk Alert: When Minimal Risk Studies Are Clinical Trials
- The Single Aim Rule
- ClinicalTrials.gov and SBR
- Decision Framework Part 1: Participant & Assignment
- Decision Framework Part 2: Effect & Outcome
- Risk Alert: Programme Evaluation vs. Research
- Practice Insight: Documenting Classification
- Ethical Imperative: Justice in SBR Classification
- Common Compliance Risks in SBR Trial Setup
- ICH E6(R3) for Behavioural Science
- Quality by Design (QbD) in SBR
- The Principle of Proportionality
- 'Investigational Product' (IP) in SBR
- Treatment Fidelity Monitoring
- R3 and Service Providers
- Data Integrity in SBR: ALCOA++
- Monitoring Non-Traditional Trials
- Investigator Responsibility for Team Qualifications
- Medical Oversight in SBR
- Quality Tolerance Limits (QTLs) for SBR
- Risk Alert: The 'Standard of Care' Trap
- Practice Insight: The Behavioural Investigator's Brochure
- Audit Readiness: Documenting Quality Systems
- Ethical Foundation of R3
- Decentralised Conduct in SBR
- Digital Health Technology (DHT) Validation
- Consent in the SBR Landscape
- Deception vs. Incomplete Disclosure
- Regulatory Criteria for Consent Waivers
- The Science of Deception Justification
- Debriefing: The Dehoaxing Process
- The Right to Withdraw Post-Debrief
- Timing and Study Contamination
- eConsent in SBR: ICH E6(R3)
- Designing Reader-Friendly Consent Documents
- Consent in Social Media Recruitment
- Active Deception and Confederates
- Risk Alert: Deception for Enrollment
- Practice Insight: Scripted Oral Consent
- Vulnerable Populations and Deception
- Ethical Conflict: When Debriefing Causes Harm
- Advanced eConsent Nuance: Remote Witnessing
- Decision Framework: How to Decide on Deception
- Safety Monitoring in the SBR Context
- SBR-Specific Adverse Events
- Defining SAEs in Behavioural Research
- The Data & Safety Monitoring Plan (DSMP)
- Psychological 'Stopping Rules'
- The Role of the Safety Officer (SO)
- The SBR DSMB: When is it Mandatory?
- Managing 'Incidental Findings'
- Confidentiality Breaches as Safety Risks
- Vulnerable Populations and Safety
- Reporting Timelines for SBR Adverse Events
- Risk Alert: 'Medicalising' the SBR Adverse Event
- Practice Insight: Distress Scales as Safety Tools
- Audit Readiness: The Safety Log
- Delta: DSMB Charters for SBR
- Enacted vs. Felt Stigma
- Social Media in the SBR Portfolio
- Predictive Targeting: The Invisible Risk
- Privacy by Design (PbD) for Recruitment
- The Comment Moderation Mandate
- Digital Unblinding and Community Sites
- Ethics of 'Lurking' and 'Creeping'
- The HIPAA/HITECH Delta in Digital Ads
- Digital Literacy and Vulnerability
- Managing Misinformation Online
- Terms of Use vs. GCP Ethics
- Risk Alert: Digital Consent Fatigue
- Practice Insight: The Social Media SOP
- Audit Readiness: The Recruitment Trail
- Terminating Participation Based on Digital Use
- Digital 'Fairness' and Subject Selection
- Monitoring the Behavioural Trial
- Risk-Based Monitoring (RBM) in R3
- Centralised Monitoring in SBR
- ALCOA++ for Qualitative Data
- Managing the Delegation of Authority (DOA)
- Evidence of Task-Specific Qualification
- Auditing the Consulting Area
- Version Control of Behavioural Scales
- Investigator Oversight in SBR
- Source Documentation Quality
- Corrective and Preventive Action (CAPA)
- Risk Alert: Personal Devices in SBR
- Practice Insight: The Monitor Checklist
- Audit Readiness: The TMF Index
- Managing 'Protocol Deviations'
- GCP and Qualitative Data Integrity
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Frequently Asked Questions
This course is an advanced refresher for experienced investigators and research professionals in social and behavioural research (SBR). Aligned with ICH E6(R3) and the NIH 2026 policy, it addresses key regulatory, ethical, and operational challenges in behavioural trials. The course focuses on Quality by Design, Risk-Based Monitoring, and ethical management of digital and decentralised research, enabling participants to confidently apply GCP standards across various SBR studies.
ul style={{ listStyleType: 'disc' }}>How to determine whether a social or behavioural study qualifies as a clinical trial under NIH 2026 and ICH E6(R3) Application of Quality by Design (QbD) and identification of Critical to Quality (CtQ) factors in SBR trials Designing and managing informed consent, including deception, incomplete disclosure, and eConsent Recognising and reporting SBR-specific adverse events such as psychological, social, and economic harm Developing and managing Data & Safety Monitoring Plans (DSMP) for behavioural research Applying Privacy by Design and managing risks in digital and social media-based research Implementing Risk-Based Monitoring (RBM) and maintaining inspection-ready quality systems Ensuring compliance with documentation standards such as ALCOA++, DOA logs, TMF, and CAPA
This course is designed for professionals involved in social and behavioural research (SBR), including:
- Principal Investigators leading SBR clinical trials
- Research Coordinators and CRAs managing behavioural study operations
- IRB professionals reviewing protocols involving digital or non-traditional methods
- Research compliance officers responsible for GCP oversight and audit readiness
- Behavioural and social scientists transitioning to interventional trial designs
- Graduate students and post-docs entering SBR trial roles
- Advanced GCP training aligned with ICH E6(R3) and NIH 2026 policy
- Practical application of Quality by Design and Risk-Based Monitoring in SBR trials
- Enhanced ability to classify behavioural studies and ensure regulatory compliance
- Expertise in managing informed consent, including deception and digital consent methods
- Improved competence in safety monitoring for psychological, social, and economic risks
- Guidance on digital ethics, privacy by design, and social media recruitment compliance
- Inspection readiness with proper documentation practices such as ALCOA++, TMF, and CAPA
- Real-world insights through scenario-based learning and case studies
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