Safety
The purpose of the Safety stop is to establish and document the Safety Data, Signals, and Oversight required to conduct the Clinical Trial.
Description
Safety considerations in clinical trials include the identification, assessment, and minimization of risks to participants. Here are some of the key safety considerations in clinical trials:
- Risk identification: The first step in ensuring safety is to identify all potential risks to participants. This includes risks from the study medication or procedure, as well as risks from the study environment.
- Risk assessment: Once potential risks have been identified, they must be assessed to determine their severity and likelihood. This assessment will help to determine which risks need to be minimized or mitigated.
- Risk minimization: Once risks have been assessed, they must be minimized or mitigated to the extent possible. This can be done through a variety of methods, such as:
DCT-specific Considerations/Inputs
What data Safety Data, Signals and Oversight need to be considered and addressed?
Technology and Data Strategy
Collaborate on Regulatory Gaps
Data Connectivity
Consider developing an automated workflow to alert PIs and study team members to key safety signals (e.g., through eSource notifications) Define key safety risks and how data is collected to assess them, as part of the data flow diagram. Define expected communication plans re:key safety risks, including how study team members at alternative site locations report key safety issues to the site PI.
Here are some of the key safety considerations in decentralized clinical trials:
- Patient access to emergency care: Patients participating in decentralized clinical trials must have access to emergency care in case of an adverse event. This can be challenging in remote areas, and it is important to have a plan in place to ensure that patients can get the care they need.
- Monitoring for adverse events: Decentralized clinical trials must have a system in place to monitor for adverse events. This can be done through electronic data capture (EDC) systems, remote monitoring systems, or patient-reported outcomes (PROs).
- Patient education: Patients participating in decentralized clinical trials must be educated about the risks and benefits of the study medication or procedure. This education should include information about how to report adverse events and how to access emergency care.
Regulatory Documents
U.S. FDA Final Guidance Document: Conducting Clinical Trials With Decentralized Elements Guidance for Industry, Investigators, and Other Interested Parties - September 2024
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