CLINICAL DATA
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 reports of quality, rather than quantity, to the various groups within the trial. One size doesn’t fit all when it comes to customising report formats. Taking the end user into consideration, rather than producing one report for all (ie identifying the relevant columns in a report, and the 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 colours.
How should clinical data managers handle clinical data reconciliation in a study? The basic step in reconciliation in a study (ie lab data, SAE (serious adverse event), PK (pharmacokinetics), PD (pharmacodynamics), diary, tumour 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 managers speed up. Since the outbreak of COVID-19 in 2020, people worldwide have realised the importance of clinical trials. Within any clinical trial the clinical data manager plays a pivotal role in their success. They should know basic SDTM mapping skills, programming, Excel and should understand metadata. A manager should also be adept at communicating and managing 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 (ie study, country, site and subject levels). They collaborate with all groups to assure that data is formatted and delivered in a timely manner with the highest data quality.
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