Table 3.

Training modules for social and behavioral best practices course

Module topics	Learning objectives By the end of this module, the participant will:
Introduction	Be familiar with the role of ICH in providing guidelines for regulations Be able to define GCP and the goals of GCP Be able to articulate how GCP relates to regulations of clinical trials in social and behavioral research
Research protocol	Describe elements of a research protocol Articulate the importance of standard operating procedures Gain knowledge in aspects of treatment fidelity as they apply to behavioral trials Be familiar with protocol violations and how to handle them
Roles and responsibilities	Understand roles and responsibilities of the sponsor, IRB, research investigator, and clinical research coordinator
Informed consent	Identify key aspects of the consent process that ensure participants rights, safety, and well-being are prioritized Analyze an informed consent process between study team member and participants to determine areas needing improvement
Confidentiality/privacy	Differentiate concepts of confidentiality and privacy Select strategies to ensure confidentiality and privacy Identify instances when confidentiality or privacy are compromised and when to report to IRB
Recruitment/retention	Identify best practices for recruitment including appropriate wording on flyers and in advertisements and ensuring adequate representation from women and diverse populations Identify strategies to retain participants
Participant safety/adverse event reporting	Be familiar with aspects of seriousness and relatedness as they relate to an adverse event Choose appropriate strategies to detect adverse events Define the role of a data safety and monitoring board
Quality control/assurance	Articulate the importance of quality assurance in a clinical trial Select strategies that can help systematically track participant progress through a study Define sources of bias that can affect data quality in a behavioral trial Assess how different biases can affect data quality from a case-based example
Research misconduct	Define research misconduct and who this applies to Describe the process for reporting an instance of misconduct Name consequences of research misconduct

GCP, Good Clinical Practice.