Clinical data managers sit at the intersection of busy information highways in clinical trials. But they do more than just direct traffic. Clinical data management is work at the infrastructure level. It includes an array of time-sensitive activities serving various stakeholders. It’s no wonder burnout and mental health problems are growing more common in clinical research.1
And yet, there are some who seem to do it all. We sat down with Justine Pierson, a battle-tested clinical data manager. While working within a leading biotech company, Justine achieved alone what it often takes whole teams to achieve.
Q: Electronic data capture systems have been around for a while. COVID-19 amplified the need for technology. This changed the role Clinical Data Managers play in clinical research. Can you tell us how this impacted you as a Data Manager?
Justine: I was a user of OpenClinica at the biotech company I worked for at the onset of COVID-19. I realized then how much we needed reliable software to capture our clinical research data. Some of our sites were relatively new to research. So, we needed user-friendly software to train staff remotely. Also, we needed flexibility to design our own reports so we could lead with real-time metrics. As a CDM, I used OpenClinica to build, test, and deploy new studies and revisions. This took less time than when our teams used a contract research organization (CRO). There is typically a lot of back-and-forth between sponsor and CRO in EDC development. That can drive up costs. OpenClinica’s self-service ability saved me tons of time.
Using OpenClinica and its modules, I could monitor data trends and queries. I could view high-level metrics like enrollment progress, average time for a site to close queries, SDV completion rates, and number of queries open at a site. My leadership team liked having this information at their fingertips. This kind of user experience made my life much easier. I could do everything I needed to meet deadlines, keep data clean, and report on the things that mattered.
Q: What impact does managing a large volume of clinical data have on a Clinical Data Manager?
Justine: The main study I was managing was a randomized trial that followed about 100 subjects for a year. There were 25 forms with varying degrees of complexity. I needed to review the queries every day to close them out or re-query as needed. I had to monitor how long it took sites to respond to these queries. This might mean conducting weekly calls with sites to close out the complex ones. I developed EDC and eCRF training materials for new sites and team members. I developed start-up documents, such as eCRF guidelines, annotated CRFs, and validation logs. I was building new databases for additional studies. One was a feasibility study, and another was going to be a large registry. The point is: managing a large volume of data is a lot for one person. You have to work hard to identify and review any data trends. You must keep it as “clean” as possible to streamline the database lock/freeze process. Plus, there is a risk that simple things will get missed. If things get missed, you have to do more data cleaning. The more data cleaning needed at database lock, the longer it takes to send clean data to the analysts. If the data is not clean, the trial and its results may come into question. That’s why Data Managers need a great technology solution. With growing volumes of data, it’s harder than ever to ensure things go off without a hitch. Without OpenClinica, my job would have been impossible for one person to do successfully.
Q: What is your advice to clinical data managers who are struggling to stay afloat due to the massive amounts of data they manage?
Justine: Automate as much as you can. OpenClinica lets you develop and test edit checks and constraints efficiently. You don’t have to depend on sites to do manual scheduling. You can set auto-scheduling rules to schedule events for when they should take place. You can generate auto-queries using edit checks. You can set up reports and queries in Insight. Just one set-up means you don’t have to do it every time a question comes up. I regularly used all these fantastic automation tools from OpenClinica to keep everything organized.
Using simple auto-queries reduces the time it takes to add, review, and close manual queries. That leaves more time to monitor the primary safety and efficacy endpoints. Rather than waiting for the site to log in to check queries, queries should be pushed to them automatically.
By using OpenClinica Insight dashboards study teams keep apprised of data quality issues in real time. The Insight reports (questions) can be set up one time and then remain in an up-to-date state. Then, instead of re-running those questions, the team can refer to them at any time. For example, it’s much easier to track questions like “Where are we with SDV?” or “What’s the most common query?”
Alerts have many uses. You can use alerts to auto-push notifications to users, based on study events. Alerts can support timely response to safety events, facilitate adjudication workflows, and much more.
Q: There are other CDMs in your position, people tasked with doing single-handed what a team would normally do. What else might you recommend doing to relieve some pressure while maintaining quality?
Justine: I’d recommend that Data Managers cross-train their teams. This keeps the data cleaning processes moving in studies that are on maintenance. Meanwhile, other teammates can focus on studies in the database lock phase. During COVID-19 some teams may experience cutbacks in human resources. In some cases, teams are simply evolving. Cross-training can make a huge difference. Without cross-training, losing someone who works on a single study means precious time lost playing catch-up. You need to learn a whole new protocol and orient yourself to the previous Data Manager’s documentation. All these things cause delays and put you at risk for errors.
I also recommend that you use your EDC’s support team. You’ll want to work with a vendor that offers professional services when and where you need them. OpenClinica did a great job with that. I worked with a Solutions Consultant at OpenClinica who was amazing. Not only do the consultants know about the software, but they also understand the clinical research space. That was incredibly helpful.
We’d like to thank Justine for offering up her experiences as a Data Manager in this interview.
- Combatting the burnout among clinical research workers. Stat News. September 13, 2021.