Understanding the concept of Clinical Data Management

Clinical Data Management is the process of handling data from clinical trials. The main goal of the a clinical data management process is to produce & maintain quality data.

Steps in the process of Clinical data management

Let’s understand the step by step flow involved in clinical data handling

1. Source data are generated. Common examples of source data are clinical site medical records, laboratory results, and patient diaries.
2. If paper Case Report Forms (CRF) are being used, the clinical site records are transcribed onto the CRF’s

1. 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 and reconciled in order to reduce the error rate.
2. The data are checked for accuracy, quality, and completeness, and problems are resolved. This often involves queries to the clinical site.
3. The database is locked when the data are considered final.
4. The data are reformatted for reporting and analysis. Tables, listings, and figures are generated.
5. The data are analyzed, and the analysis results are reported. When significant results are found, this step may result in the generation of additional tables, listings, or figures.
6. The results are integrated into high-level documentation such as Investigator’s Brochures (IBs) and Clinical Study Reports (CSRs).
7. The database and other study data are archived.

So let’s understand the elements of data quality

Computerized Systems Used in Clinical Investigations defines the fundamental elements of data quality for both paper and electronic records by “ALCOA”

Some of these elements are

• Attributable: The source of data is known.
• Legible: The data is readable & comprehensible to humans
• Contemporaneous: The data is recorded when they are generated
• Original: The data is the first recording from the primary source
• Accuracy: The data is correct.

Clinical data management (CDM) 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; the goal is to gather as much of such data for analysis as possible.

What Roles are involved in a Clinical data management

The following roles & responsibilities are important for team members involved in the process of CDM

• Data Manager – Supervises the overall CDM process
• Database programmer or designer – Performs the CRF annotation, creates the study database by enabling data validation and performs edit checks using dummy data
• Medical Coder – Helps to code the adverse events & medical history
• Clinical data coordinator – Designs the CRF by filling instructions by developing discrepancy protocol
• Quality Control associate – Checks the accuracy of data entry & helps perform data audits
• Data entry associate – Tracks the receipt of CRF pages & enters data into the database