A Unified Approach to Distributing Safety Notifications

Safety is paramount when conducting clinical research. It is crucial to ensure that study sites are well-equipped to handle safety events efficiently, which can ensure the success of the study. With newer technologies available that can streamline the safety notification distribution process for clinical trials, sponsors and CROs now have the ability to better equip their sites and maintain a perpetual state of inspection-readiness.

In the past, the clinical research community relied heavily on paper-based records for safety notifications. Implementing a unified safety portal, such as WCG’s InvestigatorSpace®, takes a significant step forward by digitalizing this process, which enhances the speed and efficiency of safety reporting from activation to close-out.

4 Steps to Simplify Delivery of Safety Notifications

By implementing a unified safety distribution process, not only do sponsors and CROs benefit, so do their clinical research sites. Let’s explore what clinical trial sites are looking for to efficiently handle safety notification acknowledgment and reporting and how they can benefit from a unified safety reporting system.

1. Reduce the amount of redundant notifications due to overreporting

Clinical trial sites are historically burdened with the overdistribution and redundancy of safety notifications. When sites are flooded with excess information, there is a greater chance of missing critical safety alerts buried in the data. Clear and effective communication can prevent overdistribution and ease site burden. Sponsors using a single portal to quickly deliver notifications of safety events (SUSARs, AEs, and SAEs) increases efficiency and improves site communication.

Furthermore, for sponsors and CROs, harmonizing global reporting with automated country rules systematizes the process, simplifies compliance, and offers real-time reporting, significantly decreasing the overdistribution to sites by only sending what is required.

2. A streamlined process for review and acknowledgment of safety notifications

Clinical trial sites often rely on disparate systems and communication channels, making it challenging to ensure that critical safety information reaches all relevant stakeholders promptly. Centralizing safety report distribution through one system allows sponsors to delegate tasks easily and ensures that only those who need to review specific documents receive them. Also, a streamlined process on one system can enable sponsors and CROs to track site compliance and site acknowledgment of notifications efficiently.

Sites benefit from a streamlined safety notification process with features like site-level assignment, delegation of signature, and multi-letter acknowledgment. Sponsors and CROs can enhance site management by allowing the site to specify how they want letters delivered to their site, including acknowledge/sign, browse with email notifications, browse only, or no access. Additionally, an automated multi-letter acknowledgment tool can consolidate safety information so that the same information across several studies only requires one acknowledgment. This ensures that all study sites and personnel receive the required safety information in a standardized and timely manner to respond to safety events promptly and appropriately.

3. Capability to acknowledge at the compound level

Many clinical trials involve multiple compounds, each with its unique safety considerations. Because most principal investigators are active in three studies at a time, there is a need to streamline the complexity of managing multiple studies with various compounds. Using a unified approach, safety notifications are documented across all applicable studies, making it easy for sites to acknowledge at the compound level.

4. Minimize safety risks in clinical trials with thorough training

It’s essential to keep studies active and ensure that study-specific training is readily available. Sponsors and CROs should make training available for sites and facilitate ongoing communication in one location to support those sites. This keeps investigators and their teams current on the latest safety protocols and specific study requirements to reduce the risk of deviations and compliance gaps. By reducing the time sites must dedicate to safety and training requirements, sites can spend more time with their patients and focus on their safety.

A Unified Approach to Distributing Safety Notifications Using InvestigatorSpace

To simplify the distribution of safety notifications and ensure regulatory compliance, it is crucial to build a strategic safety notification distribution system. WCG’s InvestigatorSpace safety portal brings together all the components necessary for efficient delivery, providing a central hub for all safety-related documentation. Study sites and investigators can access what they need quickly and confidently, ensuring the success of the study.

InvestigatorSpace offers a unified approach with safety reference tools and smart country rules for 136 countries to accelerate clinical trial activation while ensuring that safety remains at the forefront of your clinical research endeavors.

Learn more about training and safety solutions offered by InvestigatorSpace technology.