Compliance Monitoring

An Institution (NTU) has the responsibility to protect the rights and welfare of human research participants through proactive monitoring of its research activities. Under the Research Involving Human Subjects Policy, the Compliance Monitoring (CM) programme was established to:

1. Ensure the safety and well-being of human research participants
2. Ensure that research involving human subjects is being conducted, recorded, and reported in accordance with IRB-approved protocols and with prevailing ethical guidelines and procedures
3. Ensure research standards are maintained across NTU

The CM programme applies to all ‘Expedited’ and ‘Full Board’ research projects approved by NTU-IRB and conducted at NTU. This includes studies regulated under the Human Biomedical Research Act (HBRA), which states that the research institution is required to “supervise, review and proactively monitor its human biomedical research studies”.

CM Process Workflow

Scope of review

• IRB and regulatory approvals
• IRB approved documents (e.g. protocols, informed consent forms, recruitment flyers, questionnaires)
• Study team composition and training
• Subject recruitment procedures
• Signed consent forms and consent taking process
• Logs and tracking sheets (e.g. Training log, Delegation log, Eligibility screening log). Click Here for log templates
• Protocol adherence
• Data collection methods, data handling and protection
• Incident reporting
• Procedures to safeguard vulnerable populations
• Collection, use and storage of biological specimens