Overview of Clinical Data Management (CDM) in clinical research

Clinical data management (CDM) is vital in clinical research, leading to a generation of high-quality, statistically reliable, and sound data from clinical research courses. CDM ensures integration, availability, and collection of data from these clinical research trials at appropriate costs. The key vital objective of CDM is to ensure that the conclusions drawn from these research studies are accurately drawn from the received data. To gain approval for new drugs, medications, or devices from the FDA, these clinical research trial organizations must ensure that the clinical data obtained are trustworthy.

Clinical data management (CDM) is an important phase in clinical trials that leads to reliable and accurate data collection. CDM involves the entry, verification, validation, and control of the information gathered from these clinical research trials. The CDM uses an array of computer applications and database systems that can handle the collection, cleaning, and management of clinical data from various phases of the clinical research trials. 

Working of Clinical Data Management (CDM)

 To maintain the integrity of the data generated from the clinical trials, the CDM process begins at the beginning of the research trial. This phase commences even before the protocols of the trials are finalized. The CDM team designs a clinical research report defining the details of the data fields being utilized. Clinical research reports give us detailed information regarding the type of data being collected, the various measurement units being used, the guidelines of completion of the clinical trial, etc. The variables in these trial reports are generally annotated.

The following step involves forming a data management plan that behaves as a guide throughout the clinical trial. It also contains a description of the clinical trials' CDM protocols and activities. With the help of the corresponding database tools, special databases are built to support the CDM tasks. 

The three major objectives of CDM include:

1.     Collection of Data: This involves collecting corresponding data from the research trial by paper, electronic, and remote data capturing methods. It should be an optimized group to ensure accurate data collection.

2.     Integration of Data: The collection is followed by combining all the acquired data from the clinical research trials. The integration of all this data into a common database is another major objective of this department. It is generally done to ensure the consistency and accuracy of the data collected.

3.     Validation of the Data: This is done with the help of user acceptance testing (UAT). It is also guided by quality control (QC) and programming. The programming is editing check programs and manual reviews.

The major activities of a CDM include training of the personnel with the best clinical research courses from the best clinical training institute for the superior clinical research training. It also involves a data management plan, data collection, data processing, data monitoring, data safety and security, data archives, audit trails, etc.

The various roles involved in CDM

CDM requires a variety of roles to bring about all of its tasks in an efficient manner. They have several roles, each having its responsibilities. These roles include a data manager who manages and supervises the entire CDM process. The clinical data coordinator prepares the CRF and follows all the instructions while developing discrepancy protocols. CDM also requires a database designer or programmer responsible for performing the CRF annotations, creates the study database, enables validation of the data, performs edit checks, screens, and enters data. 

A medical coder is also needed for code variations such as adverse events and medical history requirements. Apart from these roles, a quality check associate is needed to check the quality and accuracy of the acquired data. Lastly, a data entry associate is needed to retrieve the CRF pages while entering data into the database.

Thus, CDM is a multidisciplinary endeavor involving handling information or data received from clinical research trials. This whole sector has developed in response to the ever-increasing demand from pharmaceutical companies and clinical research organizations to expedite the drug development process or medical treatment testing process. CDM also suffices the demand of the concerned authorities to ensure the quality of the acquired data for the drug or treatment evaluation. The clinical research courses and trial industry also faces the intense pressure of planning, implementing, and monitoring data management systems in various clinical trial research arenas where state-of-art technology swift making the infrastructure redundant. Despite these challenges, data management in clinical research is rapidly developing into a very standardized system. 

The development on the technological front has impacted the CDM protocols and systems positively. It has led to encouraging results on the quality and speed of data acquired from clinical research trials. At the same time, the various CDM professionals must ensure the standards for improving the data quality. By CDM evolving to become a standard entity of any clinical trial, striking a balance between the expectations from CRO and the constraints of the existing system is solely driven by technological development and increasing demands.