Monitoring Plan Development
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).
Watch a ReGARDD hosted workshop Monitoring responsibilities of sponsor-investigators presented by Sam Sather: