Drugs

Clinical Trial Monitoring Q & A Guide

FDA has released a draft guidance entitled “A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers” that contains recommendations on monitoring studies involving drugs, biologics and medical devices. It provides input on planning a monitoring approach, developing the monitoring plans content, and communicating monitoring results. The document expands on the 8/2013 guidance entitled “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring.”

The guidance recommends that sponsors identify and perform a risk assessment on “critical data and processes” that are necessary for human subject protection and study integrity. “The risk assessment serves to identify and understand the nature, sources, likelihood of detection, and potential causes of risks that could affect the collection of critical data or performance of critical processes,” it says.

“The risk assessment,” the guidance continues, “informs the development of a monitoring plan and may also support efforts to manage risks across a clinical investigation (for example, through modifying the protocol design or implementation) or across a product’s development program.” It further recommends that sponsors document their risk assessment, including methodologies, conclusions, and how the assessment was used to make decisions on managing risks identified. It says any such documentation should be available for review by FDA invesigators. FDA also says the monitoring plan should include information about identified risks and how monitoring methods will address these risks.

Additionally, the agency says the risk-based monitoring approaches should include processes to ensure that appropriate blinding is maintained. “Specific risks to the maintenance of the blind that are identified during the risk assessment should be mitigated in advance of investigation initiation, when feasible,” the guidance says. “In addition, identifying and tracking deviations during investigation conduct that could result in unintentional unblinding of treatment assignment should be considered as a part of the monitoring plan to ensure that appropriate blinding is maintained at [clinical investigator] sites and by the sponsor.”

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