Monitoring of Investigator-Initiated Trials

Available only for campus staff & students: Familiarise yourself with the what, when and how of monitoring a clinical trial. For externals, contact [email protected] for a case by case review of enrolment capability. 

Good Clinical Practice requires that the Sponsor ensure that their clinical trial is adequately monitored. For Investigator-Initiated Trials (IITs), the Sponsor responsibilities are shared by the institution and the Coordinating Principal Investigator (CPI), so it is essential that the CPI and team understand these obligations and how to fulfil them.

In this workshop, we will explore what is involved in determining the level and type of monitoring required (using a risk-based approach), developing a clinical monitoring plan, conducting the monitoring and reporting on it. This workshop is essential for Study Coordinators and Investigators leading IITs.

Pre-requisites: completion of a TransCelerate-recognised GCP course within the last three years and completion of the CRDO workshop: “Safety oversight, monitoring & reporting”. Please contact CRDO if you would like to discuss further.