Clinical data management (CDM) is the process of collecting and managing research data according to regulatory requirements to get high-quality information that is error-free in a Clinical Trial or Clinical Research. The objective is to obtain as much data as possible for analysis while adhering to federal, state, and local regulations.
Why Clinical Data Management is important?
Clinical data management (CDM) was developed in response to both the pharmaceutical industry and regulatory authority demands. In response to the need to accelerate the development of pharmaceuticals, regulatory bodies have established quality-assurance standards that must be met when collecting data for drug evaluation.
These two standards were created by the Clinical Data Interchange Standards Consortium (CDISC) will be particularly important to CDM: the Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG) and the Clinical Data Acquisition Standards Harmonization (CDASH). The former is currently used by the U.S. FDA (Food and Drug Administration). By creating a standard format for collecting data across studies, data submissions can be tracked and reviewed much more easily.
A wide variety of specialized software applications are used in CDM to create audit trails that allow discrepancies to be minimized even in large and complex clinical trials. Some examples are Oracle Clinical, Rave, the eClinical suite, Clintrial, and Macro. Clinical data management systems (CDMS) are especially important in studies conducted across medical centers when a large amount of data is produced.
How does Clinical Data Management work?
Data integrity is maintained by the CDM process at the very beginning of a clinical trial, even before the study protocol is finalized. Case report forms (CRFs) are designed by the CDM team, which defines the data fields to be sent to the client. Data collection forms specify the type of data to be collected, the units of measurement to be used, and completion guidelines (i.e. instructions on how to fill out the data). Each variable is annotated with a code.
This is followed by the development of a data management plan (DMP), which describes the CDM activities in the trial. CDM tasks are supported by databases and compliance tools. We test the plan before implementing it with clinical trial data. There are several steps in the process, including tracking the CFR, entering data, validating, removing discrepancies, and locking the database.
In some cases, case report forms are used to collect data by paper or electronic means; however, as technology continues to advance, electronic data collection is becoming more common. In addition, many pharmaceutical companies use remote data entry to reduce their workloads.
Roles and responsibilities of a Clinical Data Manager
There are a variety of roles and responsibilities of team members in CDM, including:
- CDM manager – supervises the CDM process.
- Designer or programmer of databases – Analyzes the CRFs, develops the study database, enables data validation, designs data entry screens, and performs edit checks using dummy data.
- Medical coder – keeps track of adverse incidents, medical histories, and other variations.
- Coordinates clinical data – designs the CRF, prepares the filling instructions, develops discrepancy protocols.
- Performing data audits and verifications of accuracy.
- The data entry associate tracks the receipt of CRF pages and enters the information into a database.
Educational Qualification required to enter CDM
Clinical data managers should have an undergraduate degree in life sciences and experience with computer applications. However, a combination of formal study (associate’s or bachelor’s) and work experience may be accepted for management and other CDM positions.
A clinical data manager usually holds one or more of the following degrees:
- Associate of Science in life sciences or computer science, pharmacy, mathematics.
- Bachelor of Science in life sciences (e.g., biology, cognitive science, ecology, microbiology, immunology, molecular genetics, neuroscience, physiology, psychobiology, psychology) or clinical research management
- Post-master’s certificate in clinical data management or clinical trials in medical device and drug development
- Organization and management of clinical research master’s degree.
- Nurse practitioner (DNP)
- Doctorate of Philosophy (Ph.D.) in clinical research
How much do clinical data managers make?
The average salary for employees with knowledge of Clinical Data Management is Over 19 lakhs. According to 133 profiles, salaries ranged from *10 lakhs per year to *47 lakhs per year. More than 30% of employees earn more than $30 lakhs a year.
What do you mean by clinical research and why is it important?
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