Table 2.

Data and Safety Monitoring Plan

Data type and description	Frequency of review
Practice recruitment and retention	Weekly, with monthly summaries for PI including a graphic of projected vs. actual
Study performance (via Practice Facilitator contact logs, we will capture number and types of personnel working with practices to support implementation, number, and type of interactions between project staff/consultants and practices, number of practices reached by the implementation, number of clinicians engaged, and percentage of PF contacts with a practice that are in-person)	Monthly summary to the PI All significant protocol deviations will be reported to the IRB during the annual review process
Implementation effectiveness (assessed via required measures.)	A monthly summary, including run charts, will be prepared from uploaded encrypted and secure data submitted from the practices to our database
Risks to participating practices (practice facilitators will be trained to monitor the time commitment of the practice to the project and to note any disruption in practice workflow or functions)	Monthly summary to the PI
Adverse events (AEs), such as breach of confidentiality	Practice facilitators will be trained to identify and report AEs as they occur to the AHEC project manager and overall project manager. The PI will be responsible for reporting AEs, as they occur, to the IRB, using UNC IRB definitions, standards, and forms
Stopping rules regarding benefits and harms	Not applicable to the study
Stopping rules regarding statistical power	Not applicable to the study