The Role Of A Clinical Data Manager

Every clinical trial generates abundant amounts of data like patient reports, medical history, age, gender, consent forms, laboratory notes, trial design, dose regimen, transcriptions copies, and much more. With such immense of data, and each piece being so important, it is highly crucial for all this data to be completely organized. Databases that are specially designed for the particular set of trials are used to achieve this.

The data is entered into the database and stored in a rows and columns format, after which it is checked for any discrepancies, which are then corrected. This data is then analyzed using statistical analysis methods before being presented to the concerned authorities. This entire process of data collection, integration, and validation is collectively known as clinical data management; and the person responsible to execute this role is known as clinical data manager.

It is the quality of data generated that decides upon the approval or disapproval of the drug, which is why it is necessary to adhere to quality standards and practices to eliminate all kinds of errors during data entry.

1)    The first stage of clinical data management involves designing of case report forms, followed by database design.

2)    The second stage of clinical data management includes data entry, validation by edit checks, making notes of queries, and medical coding.

3)    The third and last stage of clinical data management begins with severe adverse event reconciliation, which compares the data management database and that collected through SAE forms, such that there is data consistency in both the systems. After this, a database lock is done to ensure that data is not manipulated during the final analysis stage. This presents a clean database that is ready for analysis and presentation.

A clinical data manager is responsible to supervise and analyze all the aspects of clinical data. His daily tasks involve contribution to compilation, organization and production of protocols, clinical study reports, processing the collected data, and regulatory and controlled documentation. His other duties include framing the work instruction manuals, technological modifications, process modifications, preparing guidelines and operating procedures, performing regular quality control audits, and developing specifications for data management programming. Thus, his main activities include processing the clinical data, auditing the data, protecting the data, documentation, and standardizing the data management procedures.

To execute all his responsibilities well, a clinical data manager requires strong written and verbal communication skills, computer programming sills, team leading skills, and project management skills. Additionally, he must also have the qualities of critical thinking, logical reasoning, problem solving attributes, attentive listening, administration skills, cooperation, analytical thinking, and paying attention to detail.

In addition, in order to take up the role of a clinical data manager, one needs a certain level of educational qualification. This includes a bachelors or masters degree in life sciences, or a doctoral degree. Also, a certification in clinical data management qualified by an organization offering online clinical research courses in Bangalore; one like Avigna Clinical Research Institute is also applicable. Furthermore, an experience of 4-5 years in clinical data management, or a 5-10 years as a clinical research associate is required.