With progressive enhancement in Clinical Research technology over recent years, from the deployment of wearable devices to the exploration of artificial intelligence, the role of a Data Manager is once again evolving as we navigate through an increasingly complex environment. Robots can now issue our once manually raised queries directly from data review tools. They have the capability to freeze and lock eCRFs using pre-defined criteria. As we look to automate such traditional data management activities, the DM role does not go away but rather the responsibilities of this role become far more technical in their nature. With any new technology, there is a learning curve for both the vendor and the users, but are we allowing sufficient time and contingency in our planning for delivery?!

In these times where EDC databases can act as eCOA systems with Data Managers creating patient facing screens, we need a shift in our mindset, a willingness to adapt and some thoughtful database design. Our responsibilities are also broadening into the management of multiple data sources and multiple data flows and there is a definite requirement for specific Data Management systems to:

– Manage queries
– Data review
– Discrepancy review
– Listing review
– Managing and loading external data
– Data Mapping to SDTM and other formats