Kathy Yeager, BioClinica’s head of Data Management, is a very busy person. Her team of data managers, data reviewers, clinical coders, quality control associates, and forms designers has worked with over fifty sponsors and CROs in multiple therapeutic areas to provide quality data for their clinical trials. I recently sat down with Kathy to learn more about the importance of data management and how she ensures quality results for our customers.
Her team is a full service data management group who is responsible for a variety of such activities including:
1. What are your daily tasks as head of Data Management at BioClinica?
As the head of Data Management my daily tasks are to ensure that all projects are appropriately resourced and are meeting all client deliverables. I assist the project teams in troubleshooting process and system issues as well as working with clients in identifying system and process enhancements in making BioClinica’s tools better all around.
Her team is a full service data management group who is responsible for a variety of support activities for clinical trial including:
- Generation of the Data Management Plan (DMP) includes manual data review conventions
- Creation of eCCGs (eCRF Completion Guidelines)
- e-CRF preparation and edit check creation and maintenance
- Data review
- Reconciliation of SAEs and vendor data
- Medical coding
- Coding report generation
- Quality management
2. What do you think are the most effective way to communicate with sponsors?
Client communication is always a challenge and needs discussion at the beginning of a study the client’s preferred communicated method. Some clients like email, some like a phone call. In order to have effective communication with the client and the study team is to develop a communication matrix and post in the project communication plan. The matrix will identify the:
- Communication type
- Objective of communication
There are too many areas where the meaning gets misconstrued and is taken out of context which results in finger pointing or miscommunication. A discussion is always more beneficial with follow-up documentation thru minutes or email.
3. What type of metrics does your group use to track their productivity and quality?
The Data Management staff utilizes a dashboard of tasks that provide me and our senior managers with metrics necessary to manager projects and workload. These include the number of electronic case report forms (eCRF) processed, query generation and resolution, and medical coding completion. Data review metrics are based on the number of eCRFs that are populated within Express EDC (electronic data capture) by the site. The number of eCRFs is used to track against budget, identify resourcing needs based on the number of forms able to be reviewed daily, and to track against work that still needs to be done.
The BioClinica team also looks for trend in queries firing. The lead data manager will review the top and bottom 5% of queries to ensure that queries are firing appropriately. If trends are found, they will be reviewed and brought to the attention of our customer. The lead data manager and customer will then discuss the proper course of action.
BioClinica’s Data Management department has also implemented an internal quality management process where the Quality Management / Data Management staff performs a review on a subset of enrolled patients at multiple time points throughout a project. The review will be performed by reviewing the manual data review conventions with the queries generated within the database as well as query responses. Findings will be documented, researched, and updated as necessary. Any process modifications will also be performed at that time.
4. Since your group is also responsible for forms design, are there challenges when sponsors want to design a form that goes against your best practices? How do you handle this?
This occurs more often than one would think. Our data management team utilizes the system on a daily basis and continually looks for improvements. Sometimes they will see a design that can be improved upon, will not work within Express EDC, or will cause a burden on the site and study team. When this occurs, the data manager will seek out the necessary BioClinica resources, review the customer requirements, and provide the customer with the pros and cons of why their design will not work as well as a design that will streamline data collection and decrease burden.
5. How important is it that the data reviewers have experience with the protocols therapeutic area? Why?
Staff training is very important to ensure your lead data manager and data reviewers understand the protocol objectives in order to clean the data appropriately. Coming from a CRO environment, at times it is left up to the project manager or lead data manager to train data reviewers on the protocol. But who trains the project manager and lead DM? Upon coming to BioClinica, I found that the DM teams were not getting trained on the protocol by the customer. Since then, we have implemented a new process where we request that customers train the DM team on the protocol to ensure quality. If we don’t know the objectives of the protocol, we may be reviewing things differently than the customer and statistician expectations.
6. Are there any trends you are seeing in the industry when it comes to data management?
With the new risk-based monitoring approach, customers are reducing the amount of data they are collecting and focusing on only the critical areas where more time is spent on simple eCRFs where edit checks can be developed.
7. You have worked for many years with different EDC systems, what do you feel are the benefits of BioClinica’s Express EDC?
The first thing that comes to mind is how easy it is to use. Express EDC utilizes the Microsoft tree structure design which allows you start at the site level and drill down to the form level. I could go on and on, but some of the highlights for me that I did not see in other systems is ability to export data directly from the database utilizing either the listing export or the export functionality, the RECIST module for oncology trials, the local laboratory entry for sites with the derivations into the laboratory form, the push pin functionality that can be utilized for tracking of internal processes such as the completion of data review and medical coding as well as SAE triage to name a few.
8. What to you wish sponsors understood better about data management or forms design?
That there are more streamlined data collection designs that would improve data quality. Customers have standard forms and formats that are required to be used that do not fit into the EDC environment.