Table 1 Description of the tools and components of the site performance self-monitoring toolkit

Regulatory binder

A template and guidance document for tracking essential study management documentation associated with the hot flash study. It was designed to help study sites achieve and maintain regulatory compliance and adhere to common standards of practice in the conduct of research involving human subjects

Components: The sections of the regulatory binder were tailored to the planned acupuncture trial and included:

•Protocol

•Curriculum Vitae (CV)

•Licensure

•Study Logs

  oEthics Committee Communication Log

  oPre-Screening Log

  oEnrollment Log

  oDelegation of Responsibility Log/ Staff Signature Log

  oStudy monitoring Log

  oAdverse Event Tracking Log (updated during pandemic)

  oAdverse Event Reporting Form

  oProtocol Deviation/Exception Tracking Log (updated during pandemic)

  oTraining Log

  oUnanticipated Problem Log (newly added during pandemic)

•Ethics Committee (EC)

•Consent Forms

•Acupuncture Protocol

•Data Collection

•Sponsor

•Training

•Scientific Review

•Other

Study start-up checklist

A checklist for investigators/study teams to review all tasks that need to be accomplished before the site is ready to initiate participant recruitment. For example, sites must ensure the appropriate approvals have been received, staff training has been fulfilled, and the site has created data collection forms. In order to ensure site readiness, a checklist of site-specific tasks and documents was created. The study start‐up checklist was tailored to a US site and our collaborators conducted a similar process as described above to modify sections to address requirements for site readiness in China and South Korea

Self-assessment checklist

A checklist for investigators/study teams to periodically evaluate their own compliance with reporting requirements and protocol compliance over the course of the study

Study close-out checklist

A checklist for investigators/study teams to use as a self-monitoring process at end of study enrollment and once the study is ready for final close-out