Frequency and plans for auditing trial conduct {23}
To ensure compliance with GCP, all applicable regulatory requirements, as well as the protocol, ISGlobal, Unitaid (the funder), RAs, and/or ethics committees may conduct a routine quality assurance audit or regulatory inspection of this study. Additionally, in instances where there is a high occurrence of non-compliances at a trial site or misconduct is suspected, any one of the parties may institute a for-cause audit/inspection.Such audits/inspections can occur at any time during or after the completion of the study. If an audit or inspection occurs, the investigator and the research institution agree to allow the auditor/inspector direct access to all relevant documents and to allocate his/her time and the time of his/her staff to discuss findings and any relevant issues.