Clinical Data Management

by Living Wisely
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Clinical Data Management also referred to as CDM is the generation of high-quality, reliable, and statistically sound data from clinical trials. It’s a critical stage of research that that ensures the collection, integration, and availability of data at appropriate quality and cost. Clinical Data Management plays a key role in the setup, arrangement, and conduct of clinical trials. During clinical trials, data is collected and this data forms the basis of further safety and efficacy analysis which drives decision making on product development in the pharmaceutical industry. Clinical trials lay an influential role in the development and manufacturing of new drugs and medication in the pharmaceutical industry. Clinical data management is crucial and leaves little space for error. Hence, Health Catalyst constantly seeks ways to improve clinical data managements. Read more here

Clinical Data Manager

The healthcare individuals involved in a clinical trial and clinical Data Management are; clinical researcher, clinical research associate, clinical research coordinator, and clinical data manager.

The clinical data manager plays a key and arguably most important role in the setup and conduct of a clinical trial. The clinical data manager is involved in early discussions about data collection options and then oversees development of data collection tools based on the clinical trial protocol.

Once subjects for the clinical trials begin to enroll, the data manager ensures that the data collected is validated, uncorrupted, complete and consistent. The clinical data manager then liaises with other data providers (such as the central laboratory or other staff working on the trail) to ensure that the data collected is transmitted securely and that this data is consistent with other data collected during the clinical trial. The clinical data manager then puts the data management plan in motion. The data management plan describes the activities involved in processing the data. A data management plan can be a step by step guide of all the activities to be conducted, a description of data sources, data handling processes, data transfer formats and process, and quality control procedures to be applied.

At the end of the clinical trial, the clinical data manager ensures that all data expected to be captured has been accounted for and recorded and that all data management activities are complete. At this stage, the data is declared final and ready and then the clinical data manager transfers the data for statistical analysis. Clinical data managers usually have a set of terminology the use to indicate that the data is final such as “Database Lock” or Database Freeze”.

Steps of Clinical Data Management

There are various steps involved in clinical data management, the data gotten from clinical trials are very important as mentioned above and so protocol in handling this data must be followed to the tee. These are the steps:

  1. Source data is generated: Source data is the raw data gotten from the trials, it could include, lab results, patient medical records etc 
  2. Case Report Forms (CRFs): If paper Case Report Forms are being used as opposed to electronic report forms, the clinical site records are transcribed onto the paper case report forms. Using paper case forms are not as efficient as using electronic case forms.
  3. Clinical Trial Database: Data from the CRFs, as well as other source data, are entered into the clinical trial database. Electronic CRFs (eCRFs) allow data to be entered directly into the database from source documents. Data from paper CRFs are often entered twice and reconciled in order to reduce the error rate.
  4. Checking for Accuracy: The data is checked for accuracy, quality, and completeness, and any problems found are resolved. This often involves queries to the clinical site.
  5. Database Lock or Database Freeze: The database is locked when the data is considered correct and final.
  6. Reforming the Data: The data is reformatted for reporting and analysis purposes. The database manager generates tools for analysis such as tables, listings, graphs, and figures.
  7. Analysis: The data is analyzed, and the analysis results are reported. When significant results are found, this step may result in the generation of additional tables, listings, graphs, or figures.
  8. Integration: The results are integrated into high-level documentation such as Investigator’s Brochures (IBs) and Clinical Study Reports (CSRs).
  9. Archived: The database and other study data generated are archived for future use and referrals.

It all sounds easy and straightforward but within these steps, tons of error could occur which corrupts the data or result. That’s why Health Catalyst provides improvement strategies for clinical data management.