Each year, the RRO randomly selects 10% of active studies to be monitored as part of this program.
Our monitoring visit is conducted on site and includes the review of the following:
- Study files
- Source documentation including clinical charts
- Patient diaries
- Case Report Forms (CRFs)
- Serious Adverse Event (SAE) report
- Consent forms and REC correspondence.
The RRO ensures ongoing and active follow-up on research projects in order to achieve the highest possible ethical practices while offering support to research teams, as well as information sessions on ethical issues.
For any questions please contact us.