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Compliance In Focus
Posted by John Lehmann on Thu, Nov 19, 2020

3 Steps Data And Safety Managers Should Take Before A Clinical Trial

In our last post, we talked about the problems that can arise when data and safety managers aren’t aligned.


At IMARC Research, we’re fortunate to have managers with expertise in both areas. Safety manager Melanie Miller and data manager Deborah Rovniak have many years of experience working with clinical trials, and they know what it takes to set a project up for success.

Here are three best practices they shared for improving collaboration between data and safety management personnel before a trial begins.

1. Discuss data needs

You don’t want to be surprised later by assuming a critical piece of data wasn’t captured. Creating a “shell” report for the safety monitoring board or committee that includes every data point they will be expected to review, based on the study protocol, helps to set expectations.

Gather input from all parties involved to determine what types of reports they need and how often so the data manager can plan to compile them on a regular basis.

2. Establish project timelines

Both the data and safety managers should be familiar with the project schedule and key deadlines. Consider creating a spreadsheet that includes each task, who is responsible, when it will begin and when it must be complete.

3. Train sites to use the data capture system

While the data manager can compile regular reports and provide other information as needed, it’s also a good idea to empower site personnel to use the electronic data capture system. They should know how to view data and access information quickly. They also need to know when data locks will occur.

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How IMARC Research Can Help

While these best practices can go a long way to set your clinical trial up for success, there are clear advantages to outsourcing both operations to a contract research organization (CRO) like IMARC.

IMARC offers full-service data management and safety monitoring.

We can help you select the right electronic data capture system and work with site monitors to ensure timely, accurate data entry.

We also serve as a liaison between your team and your data safety monitoring boards or clinical events committee to ensure good communication throughout the project.

For more best practices for improving collaboration throughout your trial, download our latest whitepaper.


Topics: Clinical Data Management


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