Clinical trials involve mountains of data. Researchers collect data from clinical trial participants to study the effects of a new drug or medical device. Usually, they gather information to understand how different body physiologies react to a new drug or device. Managing data is easier said than done, and in this article, we feature a primer to Clinical Data Management.
Clinical data management refers to the process of collecting and managing data from clinical trials. While that might seem straightforward, it isn’t. That’s because clinical trial investigators have to ensure they collect data while adhering to data privacy regulations. In addition, they also want to ensure the collected data is accurate and error-free, which is another job that is much more difficult than it would seem.
Clinical trial data management would usually require researchers to use pen-and-paper methods in the past. However, electronic data capture systems and clinical trial data management solutions have changed the game.
Steps in Clinical Data Management
Here are some steps in the clinical data management process. They include:
- Generating source data is the first step in the clinical data management process. Typically, researchers and CROs will generate data from clinical site medical records, lab results, and patient files.
- Some researchers still use case report forms for collecting data. If a clinical trial has these reports, researchers will need to transcribe them for electronic entry.
- Researchers then insert the case report forms and other source data into their clinical trial data management software’s database.
- Researchers also need to ensure data is accurate and complete. Hence, they’ll perform source data verification.
- The researchers then lock the database once they’ve verified the source data is accurate and thus is finalized.
- Once data is finalized, researchers reformat the data for reporting and analysis. Most clinical trial data management solutions automate this process.
- Researchers begin analyzing data after reformatting it. They generate a conclusion after analyzing the data.
- Researchers may also insert data into documentation like Investigator’s Brochures (IBs) and Clinical Study Reports (CSRs).
- The final step of the clinical data management process involves archiving the data. The EU GDPR requires researchers and investigators to archive master documents for at least 25 years.
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