Routine: Routine audits involves randomly selecting studies from any of our ministries and reviewing them for compliance. This audit is Non-punitive, rather, it creates an interactive forum to help refine our processes.
For Cause: For-cause audits are not a routine compliance review and are usually triggered by the following events:Participant ComplaintWhistleblowerIRB request due to new information that might affect the rights and welfare of research subjects
Directives: This is when the IRB or Institutional Official feels that there is a need to probe further to determine if a particular trend found at a site or with a specific study necessitates an audit.