Seminars & Workshops
Good Clinical Practice for Social and Behavioral Research: Confidentiality and Privacy

After completing this lecture, you will be able to:

  1. Differentiate concepts of confidentiality and privacy
  2. Select strategies to ensure data are collected and managed in ways that assure participant confidentiality and privacy
  3. Identify instances when confidentiality or privacy are compromised
  4. Identify when and to whom reporting is necessary
Seminars & Workshops
Good Clinical Practice for Social and Behavioral Research: Informed Consent Communication

After completing this lecture, you will be able to:

  1. Outline the Informed Consent process
  2. List the required elements of informed consent process per GCP guidelines
  3. Identify key aspects of communication strategies for the consent process to ensure participants’ (including vulnerable participants’) rights, safety, and well-being are prioritized
  4. Critique informed consent communication between a study team member and participant to determine areas for improvement
Seminars & Workshops
Good Clinical Practice for Social and Behavioral Research: Introduction

After completing this lecture, you will be able to:

  1. Define the role and context of ICH in providing guidelines for regulations
  2. Show how ICH guidelines are applied to social and behavioral research
  3. Define GCP
  4. List the goals of GCP
  5. Explain how GCP relates to the regulation of clinical trials in social and behavioral research
  6. Compare the roles and responsibilities of the sponsor, institutional review board (IRB), research investigator, research coordinator, and other team members
Seminars & Workshops
Good Clinical Practice for Social and Behavioral Research: Participant Safety and AE Reporting

After completing this lecture, you will be able to:

  1. Develop communication strategies for detecting adverse events that can be used by the entire study team
  2. Develop common strategies for reporting adverse events
  3. Define the role and responsibilities of a data safety and monitoring board in a behavioral clinical trial
Seminars & Workshops
Good Clinical Practice for Social and Behavioral Research: Quality Control and Assurance

After completing this lecture, you will be able to:

  1. Explain the importance of quality control/assurance in a clinical trial
  2. Select strategies that can help systematically monitor participant progress through a study, including identifying incomplete/missing and out-of-range data
  3. Identify sources of bias that can affect data quality
  4. Assess how different biases can affect data quality using a case-based example
Seminars & Workshops
Good Clinical Practice for Social and Behavioral Research: Recruitment and Retention

After completing this lecture, you will be able to:

  1. Identify potential recruitment strategies and best practices for recruitment
  2. Assure methods are appropriate for achieving adequate participation of populations under-represented in research
  3. Identify potential strategies for participant retention
Seminars & Workshops
Good Clinical Practice for Social and Behavioral Research: Research Protocol

After completing this lecture, you will be able to:

  1. Describe the elements of clinical and IRB protocols
  2. Explain the importance of standard operating procedures (SOPs)
  3. Explain and evaluate treatment fidelity
  4. Recognize protocol deviations, identify strategies to minimize them and prevent re-occurrence, and list reporting requirements