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About

This course is an advanced refresher on Good Clinical Practice (GCP) for social and behavioural research (SBR), aligned with ICH E6(R3) and NIH 2026 policies. It focuses on the correct classification of behavioural studies using established regulatory frameworks and introduces Quality by Design principles along with identification of Critical to Quality (CtQ) factors. The course also covers Risk-Based Monitoring approaches tailored to behavioural research settings and highlights advanced informed consent processes, including deception and incomplete disclosure. It addresses safety monitoring for psychological, social, and economic risks in SBR trials and explores digital research ethics, including Privacy by Design and risks associated with online environments. Overall, the course emphasises practical application, regulatory compliance, and inspection readiness in real-world behavioural trials.

Course Syllabus

  1. The New Regulatory Threshold for SBR
  2. The NIH Definition of a Clinical Trial
  3. Delta Content: The BESH Shift (2026)
  4. Identifying the 'Intervention' in SBR
  5. Defining 'Health-Related Outcomes'
  6. The 'Prospective Assignment' Nuance
  7. Risk Alert: When Minimal Risk Studies Are Clinical Trials
  8. The Single Aim Rule
  9. ClinicalTrials.gov and SBR
  10. Decision Framework Part 1: Participant & Assignment
  11. Decision Framework Part 2: Effect & Outcome
  12. Risk Alert: Programme Evaluation vs. Research
  13. Practice Insight: Documenting Classification
  14. Ethical Imperative: Justice in SBR Classification
  15. Common Compliance Risks in SBR Trial Setup

  1. ICH E6(R3) for Behavioural Science
  2. Quality by Design (QbD) in SBR
  3. The Principle of Proportionality
  4. 'Investigational Product' (IP) in SBR
  5. Treatment Fidelity Monitoring
  6. R3 and Service Providers
  7. Data Integrity in SBR: ALCOA++
  8. Monitoring Non-Traditional Trials
  9. Investigator Responsibility for Team Qualifications
  10. Medical Oversight in SBR
  11. Quality Tolerance Limits (QTLs) for SBR
  12. Risk Alert: The 'Standard of Care' Trap
  13. Practice Insight: The Behavioural Investigator's Brochure
  14. Audit Readiness: Documenting Quality Systems
  15. Ethical Foundation of R3
  16. Decentralised Conduct in SBR
  17. Digital Health Technology (DHT) Validation

  1. Consent in the SBR Landscape
  2. Deception vs. Incomplete Disclosure
  3. Regulatory Criteria for Consent Waivers
  4. The Science of Deception Justification
  5. Debriefing: The Dehoaxing Process
  6. The Right to Withdraw Post-Debrief
  7. Timing and Study Contamination
  8. eConsent in SBR: ICH E6(R3)
  9. Designing Reader-Friendly Consent Documents
  10. Consent in Social Media Recruitment
  11. Active Deception and Confederates
  12. Risk Alert: Deception for Enrollment
  13. Practice Insight: Scripted Oral Consent
  14. Vulnerable Populations and Deception
  15. Ethical Conflict: When Debriefing Causes Harm
  16. Advanced eConsent Nuance: Remote Witnessing
  17. Decision Framework: How to Decide on Deception

  1. Safety Monitoring in the SBR Context
  2. SBR-Specific Adverse Events
  3. Defining SAEs in Behavioural Research
  4. The Data & Safety Monitoring Plan (DSMP)
  5. Psychological 'Stopping Rules'
  6. The Role of the Safety Officer (SO)
  7. The SBR DSMB: When is it Mandatory?
  8. Managing 'Incidental Findings'
  9. Confidentiality Breaches as Safety Risks
  10. Vulnerable Populations and Safety
  11. Reporting Timelines for SBR Adverse Events
  12. Risk Alert: 'Medicalising' the SBR Adverse Event
  13. Practice Insight: Distress Scales as Safety Tools
  14. Audit Readiness: The Safety Log
  15. Delta: DSMB Charters for SBR
  16. Enacted vs. Felt Stigma

  1. Social Media in the SBR Portfolio
  2. Predictive Targeting: The Invisible Risk
  3. Privacy by Design (PbD) for Recruitment
  4. The Comment Moderation Mandate
  5. Digital Unblinding and Community Sites
  6. Ethics of 'Lurking' and 'Creeping'
  7. The HIPAA/HITECH Delta in Digital Ads
  8. Digital Literacy and Vulnerability
  9. Managing Misinformation Online
  10. Terms of Use vs. GCP Ethics
  11. Risk Alert: Digital Consent Fatigue
  12. Practice Insight: The Social Media SOP
  13. Audit Readiness: The Recruitment Trail
  14. Terminating Participation Based on Digital Use
  15. Digital 'Fairness' and Subject Selection

  1. Monitoring the Behavioural Trial
  2. Risk-Based Monitoring (RBM) in R3
  3. Centralised Monitoring in SBR
  4. ALCOA++ for Qualitative Data
  5. Managing the Delegation of Authority (DOA)
  6. Evidence of Task-Specific Qualification
  7. Auditing the Consulting Area
  8. Version Control of Behavioural Scales
  9. Investigator Oversight in SBR
  10. Source Documentation Quality
  11. Corrective and Preventive Action (CAPA)
  12. Risk Alert: Personal Devices in SBR
  13. Practice Insight: The Monitor Checklist
  14. Audit Readiness: The TMF Index
  15. Managing 'Protocol Deviations'
  16. 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.

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  • 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
    This course is intended for individuals with foundational GCP knowledge who want to apply advanced principles in SBR contexts.

    • 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