Monitoring Strategy / Plan
The purpose of the Monitoring Strategy / Plan stop is to develop and document a strategy/plan for complying with Good Clinical Practices of continuously monitoring the rights and well-being of study participants, the conduct of the trial by all research sites, and trial data to ensure protocol compliance and compliance to all regulatory requirements.
Description
Trial monitoring plans are used to ensure that clinical trials are conducted according to the protocol and that the safety and rights of patients are protected.
A trial monitoring plan is a document that describes how a clinical trial will be monitored. It includes information on the frequency and methods of monitoring, the roles and responsibilities of the monitors, and the procedures for addressing any issues that are identified during monitoring.
Trial monitoring is an essential part of clinical trials. It helps to ensure that the trial is conducted according to the protocol, that the safety and rights of patients are protected, and that the data collected is accurate and reliable.
The frequency and methods of monitoring will vary depending on the specific trial. However, all trial monitoring plans should include the following elements:
- A description of the roles and responsibilities of the monitors.
- A description of the procedures for addressing any issues that are identified during monitoring.
- A timeline for the monitoring process.
- Trial monitoring plans are an important tool for ensuring the quality and integrity of clinical trials.
DCT-specific Considerations/Inputs
What is reviewed, queried, verified, and by whom?
What is reviewed and unchanged?
PI oversight for assessments / data collected at alternative sites and / or by HCPs must be monitored and documented.
Per FDA Draft Guidance: Decentralized Clinical Trials for Drugs, Biological Products, and Devices (Section D.1)
Sponsors must ensure proper monitoring of an investigation. As with any trial, sponsors may use a variety of approaches to monitor DCTs, and the monitoring plan for a trial should be based on the sponsor's risk assessment. A trial monitoring plan should:
- describe how monitoring will be implemented to assess protocol compliance and data quality and integrity,
- specify the frequency with which trial records and source documents will be reviewed, and
- note any unique aspects related to the DCT procedures.
FDA encourages risk-based monitoring approaches and use of centralized monitoring to identify and proactively follow up on missing data, inconsistent data, data outliers, and potential protocol deviations that may be indicative of systemic or significant errors.
Tools
Regulatory Documents
FDA/U.S.
U.S. FDA Final Guidance Document: Conducting Clinical Trials With Decentralized Elements Guidance for Industry, Investigators, and Other Interested Parties - September 2024
View21 CFR Part 312 Investigational New Drug Application
ViewFDA Guidance for Industry: Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring
View