Prelude recently presented at the Society of Clinical Data Manager’s Annual Conference held in Orlando, Florida. Alicia Browner, Ph.D., our CTO, was joined on a speaking panel by Karen Lane, Ph.D. from John Hopkins University and Jess Wofford, DVM from Aratana Therapeutics. Together, they provided an overview of the changing role of Data Managers in a technology-infused clinical trial environment. For those that did not have the opportunity to attend, we would like to share some of the key points presented:

  • Early engagement of the data manager(s) for an EDC-implemented study is imperative – especially in the initial phases of electronic study development and design. Data managers are experts for cleaning data, quality-controlling data input and entry, and are invaluable in testing an EDC system against data capture compliance and regulations and adherence to protocol.
  • One of the roles of data managers is to become the knowledgeable advisor that can look at the EDC critically and leverage all of it’s functionality to clean data as it is entered, in real-time. This is achieved through automatic edit checks, custom calculations and algorithms. All this reduces the amount of monitoring necessary and improves the quality of the data.
  • When it comes to monitoring, the data managers are instrumental in identifying risk within the study. If risk-based monitoring will be implemented, the data managers could help identify areas in which there might be a protocol deviation, where data might not be entered contemporaneously and how that might be monitored. Data managers could find what fields should be strategically scrutinized to ensure patient safety. This includes requiring certain users to be automatically notified if certain criteria are met and how to identify fraudulent data or deal with missing data.
  • Data managers can also influence day to day operations by helping the team understand and use other EDC functionality such as inventory management, automatic reordering, invoicing, document management, and more. These automated functions can streamline operations while improving data quality dramatically – definitely a winning strategy!

During the panel, Karen Lane of John Hopkins University shared how they used the system to track performance and enrollment metrics. One graph showed the significant increase of efficiency they experienced in enrollment when they moved to EDC. They also created a friendly competition among sites to encourage enrollment and had a dashboard where sites could quickly view their ranking. The result was a dramatic improvement in enrollment.

 

Jess Wofford of Aratana Therapeutics shared their lessons learned in adopting EDC. One issue they had previously experienced was that sites used different units of measurement for weight and the subsequent human errors in converting those to a consistent unit. They solved this with EDC by enabling the sites to select only lbs or kgs and the system automatically calculating the conversions (lbs to kgs and vice versa.) While this might sound simple, it really was genius; some scales measuring in lbs read out both lbs and ounces while others provide lbs with decimal points. To account for this two text fields were provided in the EDC. The fields for lbs could be used to enter whole lbs or lbs with decimals depending on what the scale displayed, and for those scales showing ounces, the information was entered into the corresponding field. (See Figure 1) This was extremely helpful in helping accurately track the weight.
Figure 1. Body weight measurements and automatic conversions.

Aratana also took advantage of the EDC capability which hides forms once they’ve been signed off. Why is this so important? It helps to reduce bias when conducting repeated measures. During the session, Dr. Wofford also mentioned that they added a function where the monitor could make the form reappear if there was an outstanding query so the query could be answered and resolved. They thought of everything!

We greatly appreciate Aratana’s Dr. Wofford and Johns Hopkins’ Dr. Lane for sharing their experiences and providing lessons learned from their own perspective and illustrating the importance of the data manager role in EDC-driven studies. One thing is clear from the presentation: Data Managers can serve a crucial role in the development, design and risk assessment of EDC-driven clinical studies and we at Prelude look forward to working alongside DMs to deliver study data capture that is clean, accurate, risk-averse and quality-driven.