How Is the Role of Clinical Data Manager Changing and Why?
Clinical data managers (CDMs) have experienced a significant change in their duties over the past 20 years as the industry has shifted toward more detailed protocols and data gathering needs. The senior clinical data manager notes that if someone has been in data management for the last 20 years, it’s likely that they began by using paper (CRO). However, with the arrival of electronic medical records, CDMs found themselves in charge of a never-ending list of additional data sources, including e-Source, electronic clinical outcome assessment, and bring your device all of which were controlled by competing software platforms.
Many of the latest data gathering and analytics developments fell to CDMs to figure out over time because they are one of the only positions in the clinical research sector with the term “data” in the title.
CDMs suddenly started to wear many hats: computer programmer, clinical data management, clinical operations expert, and biostatistician, all in one, as the function grew to keep up with the rapid rate of technological development.
How have the COVID-19 pandemic’s effects on data gathering for clinical trials and data managers’ daily lives changed?
The COVID-19 pandemic significantly altered how we conducted clinical trials, including nil or very limited communication with the sites and no opportunity for onsite clinical trial data management. As a result, we determined that we lacked the tools or procedures necessary to conduct a proper data oversight remotely.
We had to act swiftly to implement changes to the eCRF that would permit telephone visits, modify validation checks to allow longer time windows, collect more information to support missed appointments or examinations when a patient underwent a telephone interview rather than an in-person visit, and reconsider protocol deviations that the pandemic might have brought on. We had to be quick and adaptable to implement all of these modifications in clinical data management.
At the same time, we had to look into the advice and guidelines provided by several regulatory agencies, including the FDA and EMA, and put their advice into practice for handling pandemic issues for clinical studies.
Clinical Trials Data Management That Are Remote and Distributed
CROs have persisted with remote and decentralized clinical trials in the years after the lockdowns and limitations caused by the COVID-19 outbreak. As a outcome, these researchers were able to go from following emergency procedures to seizing new chances for clinical data management.
Clinical data managers are also making changes to how they handle remote teams. It takes a lot of coordination to manage multiple researchers who are spread out across the nation. Leaders must take precautions to avoid overwork or burnout and increase communication and preparation while using remote management.
Burnout is risky for any business, but it may be particularly fatal in clinical trials. Team leaders cannot afford to overwork their staff because the data is inaccurate and useless.
Clinical data managers are altering how trials are developed and operate today. However, it’s not necessary for the data manager position to cover all tangentially linked areas of information. Instead, these professionals may help sponsors and CROs enter the future of clinical trial operations by investing in greater human resource management and technical advancements.
Why Is the Role of the Clinical Data Manager Important?
To obtain data of the greatest quality, the clinical data manager works in conjunction with numerous organisations ( clinical sites, clinical operations, medical professionals). They are the main contact for data and are crucial to a clinical trial’s success. Unfortunately, the clinical data manager’s position is like a punching bag. Depending on the data issue, they may be praised or derided instantly.
What Qualities Make a Successful Clinical Data Manager?
Clinical data managers collaborate closely with other teams during a clinical trial to guarantee that data is gathered, handled, and reported promptly, correctly, and securely.
Protocol deviations, metadata, Good clinical practices (GCP), protocol, basic SDTM mapping, programming, and Excel are all concepts that clinical data management must be familiar with. Additionally, the clinical data manager must swiftly inform the trial’s key groups and team members of any data concerns.
What Review and Communication Processes Does the Clinical Data Manager Use Within a Clinical Team?
The clinical data management team has received ongoing reports of clinical data since the beginning. The clinical data manager emphasizes providing high-quality reports to all trial groups more than quantity. Therefore, customizing report formats is not a one-size-fits-all proposition.
Instead of creating one report for everyone, keeping the end user in mind is important. This means choosing the right report columns and using the correct sorting order.
Clinical data managers may choose to format and disseminate operational data for some reports. Still, baseline comparison data reports must be in SDTM simple format and not at the submission level. Baseline value comparison reports are essential if clinical data is gathered throughout numerous cycles or visits. A more comprehensive data evaluation can be obtained by grouping some papers by study, country, site, and subject. Patient profiles should be made as simple as possible with a minimal amount of columns, sorted by domain/table and variables, and colored to indicate modifications and new data.
An arsenal for clinical data management managers
Tools that make decision-making easier are essential for clinical data management.
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