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Compliance In Focus
Posted by Melanie Miller on Fri, Nov 13, 2020

Why Safety and Data Management Silos Can Be Dangerous

When it comes to collecting and reviewing clinical trial data, your data and safety management teams need to be closely aligned.

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In many clinical trials, however, they work in parallel to each other rather than collaborating effectively.

This can result in miscommunication, inefficiencies, and potential risks to patient safety.

Here’s a closer look at these two vital functions and what can happen when they aren’t on the same page.

Data And Safety Management Roles

The data manager develops a statistical analysis plan and plays an important role in selecting, preparing, and maintaining your electronic data capture (EDC) system. They serve as the main point of contact for providing data related to the trial and should work closely with all team members to ensure they have the information they need.

The safety manager works closely with the Data Safety Monitoring Board (DSMB) and Clinical Events Committee (CEC) to review safety-related data.

That includes recruiting, onboarding, and training safety board or committee members. They also establish meeting times and processes.

3 Big Problems With Data And Safety Silos

Without strong communication between data and safety managers from the beginning, your clinical trial can encounter several issues later.

Here are three of the most significant ones.

1. Not gathering the right data

Whether you’re working with a DSMB, CEC or both, they will likely have expectations about the type of data they will review, how often they will receive it, and what format it will be in.

Your data manager likely has similar expectations based on the work they’ve done for previous projects. However, if the safety manager and data manager haven’t explicitly discussed this, the safety manager may make certain assumptions about what information is being collected.

For instance, if they need to monitor specific endpoints that the data manager has not outlined in the statistical analysis plan, they may be unable to effectively do their job. They need to understand what data is being collected and how to access it using the electronic data capture system.

2. An inefficient process

Both the data and safety manager need to receive certain information in a timely manner to fulfill their responsibilities. For instance, the CEC will need access to your EDC system to complete adjudications at certain endpoints. Your data manager will also need to manage data locks. If both of these functions are happening at the same time, you’ll run into roadblocks.

Make sure you’ve established key milestones upfront and you know how long each task will take to complete so you can develop the most efficient processes.

3. A lack of data integrity

When the safety board or committee meets, they rely on the data manager to compile reports.

At the same time, if the safety monitoring boards or committee has established its own process for collecting and reviewing data, their process may differ from those of the data manager. For instance, a safety monitoring board may rely on phone calls or emails to discuss adverse events. This may make it difficult to maintain data integrity.

Eliminate Silos With A Full-Service CRO

As a full-service contract research organization, IMARC offers both data management and safety monitoring services using consistent, well-established processes.

We can help you select the right electronic data capture system, build it according to your specifications, and work with site monitors to ensure data is entered accurately and in a timely manner. We can sort, clean, and analyze your clinical trial data and assist with database locking as your trial comes to a close.

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We can also help you recruit qualified physicians for a data safety monitoring board or clinical events committee and serve as a single point of contact between them.

Outsourcing your data and safety management to us eliminates silos so you can focus on bringing your device to market faster.

For practical tips on how to improve collaboration between data and safety management, download our latest whitepaper.

Topics: Clinical Data Management

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