Monitoring

What is Monitoring?

Monitoring is:
•    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.

Is Monitoring Required?

Monitoring of clinical investigations by sponsors is mandatory (not optional) under FDA drug & device regulations.  Monitoring demonstrates that the sponsor-investigator (S-I) is taking steps to ensure the adequate protection of the rights, welfare, and safety of human subjects and the quality of the clinical trial data submitted to FDA.*

*Guidance for Industry: Oversight of Clinical Investigations, A Risk-Based Approach to Monitoring

Is a Monitoring Plan Required?

The Emory IRB requires a monitoring plan for studies which are more than minimal risk.  The study sponsor or S-I is responsible for ensuring an appropriate monitoring plan is part of trial management systems.

What needs to be included in a Monitoring Plan?

An overall Data Safety Monitoring Plan (DSMP) must include a plan for both (1) review of subject safety and welfare; along with (2) site monitoring for data accuracy and protocol compliance.  FDA recommends that sponsors tailor the monitoring plan for the specific human subject protection and data integrity risks of the trial.

Would DSMB Review meet the requirements for monitoring and a monitoring plan?

If a research protocol involves an increased level of risk, the IRB may require a Data and Safety Monitoring Board (DSMB) in order to ensure that subjects are protected, reporting requirements are met, and that the data is kept confidential. Review by a DSMB or medical monitor may be part of the overall monitoring plan but it is not the entire monitoring plan.

What is a Site Monitoring Plan?

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  

What is Self-Monitoring and is it Adequate?

Self-monitoring which is a process for self-assessment of protocol compliance and data integrity can be part of an overall DSMP.  Depending on the degree of risks to subjects, the IRB may consider a monitoring plan which relies on self-monitoring as adequate for a study conducted only at Emory. Click here for a Self-Monitoring Tool.

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.

Are tools available to S-I for Site Monitoring?

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

Resources:
Guidance for Industry: Oversight of Clinical Investigations, A Risk-Based Approach to Monitoring
Data and Safety Monitoring Plan Writing Guidance