We provide support to Principle Investigators in the ongoing monitoring of clinical trials and studies.

• Development of data and safety monitoring plans
• Review grants for adequacy of human subject protection
• Appropriateness of using a data and safety monitoring board
• Audit preparation
• Guidance on Adverse Event and Unanticipated Problem reporting

Study monitoring is assuming responsibility for reviewing events and outcomes during the implementation of a study in two domains: 1) the safety of participants (protecting the rights of subjects, monitoring for the occurrence of adverse events, continuing to assess the risk/benefit ratio). 2) the integrity and quality of the data (monitoring the trial data for accuracy/completeness, ensuring the data is verifiable, verifying that the trial was conducted in compliance with the protocol, GCPs, local regulatory requirements and approvals).

The level of monitoring should be commensurate with the size and complexity of the trial, the level of risk to study participants, and phase of the trial. Learn more about developing a Data and Safety Monitoring Plan or need for a Monitoring Group/Board (.docx).

Watch a ReGARDD hosted workshop — Monitoring responsibilities of sponsor-investigators presented by Sam Sather: