The Importance of a Clinical Data Manager in Clinical Data Management Strategies
The handling and presenting of data is critical for any clinical trial's success. Most people think drug approval takes only a couple of years, but it actually takes anywhere between eight to ten years, and authorities (FDA, EUA, PDMA) take considerable time to review and approve any drug for human use or consumption. Within this process, clinical data management and the clinical data manager play a vital role in clinical trial success. In this article, you’ll learn answers to a series of questions on clinical data management, the role of a clinical data manager and why this role is so connected to effective data management.
What Is Clinical Data Management?
Clinical data management is a key group within the clinical trial process. It plays an essential role in the data collection phase of clinical research. The process of collecting and managing research data is done in accordance with regulatory standards to obtain quality information that is complete and error-free. Therefore, clinical data management is different from traditional data management.
Why Is the Clinical Data Manager Role Important?
The clinical data manager collaborates with various groups (clinical operations, medical experts, clinical sites) to get the highest data quality. He/She plays a vital role in the success of a clinical trial and is the point of contact for data. The role is like a punching bag—the clinical data manager is appreciated or punched in a second on any data issue!
What Skills Are Required to Be an Effective Clinical Data Manager?
Clinical data managers work closely with other groups within a clinical trial to ensure that data is collected, managed and reported in a timely manner, accurately, and securely.
The clinical data manager must understand good clinical practices (GCP), protocol, protocol deviations, metadata, basic SDTM mapping, programming and Excel. In addition, the clinical data manager must communicate data issues to team members and the other key groups promptly throughout the trial.
How Does the Clinical Data Manager Review and Communicate Data Within a Clinical Team?
From day one, clinical data is being reported on an ongoing basis to the clinical data management team. The clinical data manager focuses on delivering quality reports rather than quantity to all groups within the trial. One size doesn't fit all when it comes to customizing report formats. Taking the end-user into consideration rather than one report to all (i.e., identifying the right columns in a report and proper sorting order) is key.
When it comes to formatting and distributing the data, clinical data managers can decide to use operational data for some reports, but for baseline comparison data, the report has to be in SDTM simple format and not at the submission level. Baseline value comparison reports are critical if clinical data is collected within multiple cycles or visits. Some reports can be grouped by study, country, site and subject to obtain a more holistic data review. Patient profiles should be simplified with a limited number of columns, sorted by domain/table and variables, highlighting changes and/or new records in different colors.
How Should Clinical Data Managers Handle Clinical Data Reconciliation in a Study?
The basic step in reconciliation in a study (i.e. lab data, SAE, PK, PD, diary, tumor data..) is to focus at a high level, such as subject and demographic details. If they don't match, the programming team should skip the reconciliation of other fields. Separating section level reconciliation will help data managers do it faster.
Since the outbreak of COVID-19 in 2020, people worldwide have realized the importance of clinical trials. Within any clinical trial the clinical data manager plays a pivotal role in its success. A clinical data manager should know basic SDTM mapping skills, programming, Excel and should understand metadata. The clinical data manager should also be adept at communicating and managing among multiple clinical trials simultaneously, at the compound, project and study level. When reviewing the data, the clinical data manager must always think at a broad level (i.e study level, country level, site level and subject level). They collaborate with all groups to assure that data is formatted and delivered in a timely manner with the highest data quality.