Table 1.

Updates for the social and behavioral research training course by module

Course Modules	Major Changes
Introduction	Added context to highlight skills learners need to have to conduct a research study with rigor and outlined all course module topics. Clarified roles and responsibilities of study team, such as the role of a data safety monitor in a behavioral research study Added Data Safety Monitoring Board and Advisory Board to roles Removed Office of Research Integrity to add elsewhere
Research Protocol	Rewrote the module to focus on protocol document as the foundational study document and how it informs supporting documents Reframed the module to better reflect a best practice in the video learning scenario and a more common issue that study teams might encounter Eliminated potentially confusing terms “clinical protocol,” and “IRB protocol” to the more general term of protocol document Clarified that the protocol is a living document that needs to be updated and amended as needed Removed details about protocol deviation reporting to add elsewhere Added resources for protocol document writing, such as the NIH behavioral clinical trial protocol template
Recruitment and Retention	Added information about including community advisory boards or stakeholders into developing recruitment strategies Added information about social media and online recruitment Added practical strategies in best practices regarding accommodating research participants
Informed Consent Communication	Changed knowledge check question feedback to be more accurate Updated confidentiality information and information about incentive payments Added information about e-Consent Added considerations in the consent process for people with cognitive impairments or hearing/visual disabilities
Privacy and Confidentiality	Updated knowledge check responses to remove old technology (thumb drives) and provide better explanations when a wrong answer is selected Added information about data sharing, including a data sharing plan Added information about password protection such as two factor authentication Updated images of outdated technology, like a mini cassette recorder
Participant Safety and Adverse Events	Changed knowledge check questions around the video to be more nuanced and provide more information for learners Added information about data safety and monitoring plans and study-specific adverse event reporting Added an “unanticipated problems” section Added clarifying information about classifying and reporting adverse events
Quality Control and Assurance	Revised knowledge check responses Added regulations for reporting requirements of results and importance of logging issues affecting data quality
Research Misconduct	Changed the guidance to reflect contacting Office of Research Integrity to discuss potential research misconduct instead of IRB
Conclusion	Added CASE module to course summary