• An ongoing process of overseeing the progress of a clinical trial from start to finish.
• A quality control tool for determining whether study activities are being carried out as planned, so that deficiencies in the conduct, record keeping or reporting can be identified and corrected.
*Guidance for Industry: Oversight of Clinical Investigations, A Risk-Based Approach to Monitoring
Site Monitoring is conducted to ensure that the study is conducted in accordance with the protocol including study procedures, study intervention, and data collection processes.
The site monitoring plan should include:
• Monitoring methods (may include centralized, on-site and self-monitoring).
• Timing, frequency, and intensity of monitoring
• Reference to any tools used (i.e. checklists)
• Identification of events that may trigger changes
• Identification of deviations or failures that would be critical to study integrity
• Categorization of activities done centrally and those on-site
If the S-I has more than one site (making him/her a sponsor at an external site), self-monitoring by the on-site investigator likely will not be considered adequate. The monitoring plan may be required to include use of a Contract Research Organization (CRO) or other monitoring alternatives before IRB approval can be obtained.
The following links provide self-monitoring tools for Emory sponsors and sponsor-investigators which can be incorporated as part of a monitoring plan:
• S-I IND/IDE Trial Initiation Checklist
• S-I IND/IDE Regulatory Documentation Checklist Item Descriptions
• Emory Sponsor Regulatory IND Checklist
• Emory Sponsor Regulatory IDE Checklist (coming soon)
• Emory Sponsor IND/IDE Multi-site Regulatory documentation Checklist