What is Clinical Data Management (CDM)?

Clinical data management (CDM) is the process of collecting and managing research data in accordance with regulatory standards to obtain quality information that is complete and error-free. The goal is to gather as much such data for analysis as possible that adheres to federal, state, and local regulations.

The field of clinical data management (CDM) has come about due to demands from both the pharmaceutical industry and the regulatory authorities. As the drive to “fast-track” the development of pharmaceutical products continues to accelerate, regulatory entities have responded by requiring quality-assurance standards to be met in collecting the data used in the drug evaluation process.

Two such standards created by the Clinical Data Interchange Standards Consortium (CDISC) are particularly vital to CDM: the Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG), which is currently mandated for use by the U.S. Food and Drug Administration (FDA). Its counterpart is the Clinical Data Acquisition Standards Harmonization (CDASH) created a standard format for collecting data across studies so that data submissions can be more easily tracked and reviewed.

Specialized software applications are used in CDM to create audit trails that allow discrepancies to be minimized even in large and complex clinical trials. Examples include Oracle Clinical, Rave, eClinical suite, Clintrial, and Macro. Clinical data management systems (CDMS) are especially vital in trials conducted across medical centers in which an enormous amount of data is produced.

CDMSs can be customized and may be tailor-made in the case of large, multinational pharmaceutical companies looking for tools that address the needs of their specific companies. In addition, open-source tools such as TrailDB, open CDMS, OpenClinica, and PhOSCo are freely available and can be just as effective.

Set standards guide the work of CDM professionals because, as mentioned above, the information is used in the pharmaceutical industry to evaluate medicine. In addition, the Code of Federal Regulations (CFR), 21 CFR Part 11, provides the compliance standards to which CDM systems must adhere.

What does it take to become a clinical data manager? According to O*NET OnLine, sponsored by the U.S. Department of Labor, 85 percent of clinical data managers have a bachelor’s degree. In 2023, the U.S. Bureau of Labor Statistics (BLS) shows that clinical laboratory technologists, a similar occupation, typically have bachelor’s degrees in medical technology or biology.

Between 2022 and 2032, the BLS (2023) projects that jobs for clinical laboratory technicians and technologists (a related field) will grow 5 percent nationally, which is faster than the national average for all occupations (3 percent). What’s more, it’s estimated that 16,800 new clinical data management positions will be needed in the coming decade, and the median annual salary for this position is $57,380.

Read on to learn about clinical data management workflow, professions, certifications, degree programs, and specializations.

To maintain data integrity, the CDM process starts at the start of a clinical trial, even before the study protocol is finalized. The CDM team designs a case report form (CRF) and defines the data fields. CRFs specify the data type to be collected, the units of measurement, and CRF completion guidelines. Variables are using annotated coded terms.

A data management plan (DMP) is then developed as a guide, including a description of the trial’s CDM activities. Next, databases are built to support CDM tasks with corresponding compliance tools. Finally, testing is done before using the plan with actual clinical trial data. CFR tracking, data entry, validation, discrepancy management, medical coding, and database locking are subsequent steps in the process.

Case report forms may be used to collect data by paper or electronic means; however, as technology has continued to evolve, the trend towards electronic data collection has followed suit. Furthermore, many pharmaceutical companies have adopted remote data entry or e-CRF as a time-saving measure.

CDM requires a variety of roles and responsibilities of team members and takes the form of:

• Data manager – supervises the CDM process
• Database programmer or designer – performs the CRF annotation, creates the study database, enables data validation, designs data entry screens, and performs edit checks using dummy data
• Medical coder – codes variations such as adverse events and medical history
• Clinical data analyst – designs the CRF, prepares the filling instructions, develops discrepancy protocols
• Quality control associate – checks the accuracy of data entry and performs data audits
• Data entry associate – tracks the receipt of CRF pages and enters data into a database
• Clinical research associate – serves as a go-between for the sponsors funding the research and the clinical participants and employees

To become a certified clinical data manager (CCDM) and be recognized as a trained and qualified professional in this field, the Society for Clinical Data Management offers a certification program.

In addition to the personal and professional benefits that certification provides, such as validation of one’s skills and expertise, earning certification comes with various organizational benefits. These include having a competitive CDM team with the highest level of competence in the industry, stellar professional development opportunities, and optimizing the quality of company practices and outcomes.

To become a certified clinical data manager, applicants must have one of the following:

• A bachelor’s degree or higher and at least two years of full-time CDM experience
• An associate’s degree and three years of full-time CDM experience
• Four years of full-time CDM experience
• Part-time work experience that equals or exceeds the criteria mentioned above

Applicants do not need to be members of the Society for Clinical Data Management, nor must they be currently employed as a manager at the time of application. Once the electronic application and fees have been submitted, approved candidates will receive a letter of acceptance within 14 days and an eligibility number needed to schedule the exam. Candidates will have 30 days from the date stated on their acceptance letters to take the exam. The exam consists of 130 multiple choice questions and must be completed in three and a half hours. SCDM offers a variety of materials to assist candidates in preparing. In 2023, exam fees range from $60 to $325 depending on member status and the income level of an applicant’s country.

The desired requirement for clinical data managers is an undergraduate degree in life sciences and knowledge of computer applications. However, schools may accept a combination of formal study (associate’s or bachelor’s) and work experience for management and other CDM positions.

Ideally, medical coders are med-tech program graduates, but employers may recruit paramedical and other healthcare professionals for such roles. Clinical data managers usually have one or a combination 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
• Master of science in clinical research management
• Doctor of nursing practice (DNP)
• Doctor of philosophy (PhD) in clinical research

Here is a list of sample programs that can lead to a career in clinical data management.

Arizona State University offers an online bachelor of science in business data analytics. This 120-credit program teaches students to manipulate big data sets and translate their significance into data-driven decisions. These skills are helpful in all private, public, and non-profit employment settings. Courses include Introduction to Business Data Analytics, Introduction to Information Systems, and Business Data warehouses and dimensional modeling.

To apply, students must be admitted to ASU and have already completed 30 semester hours of courses in mathematics, computer and information science, and economics. In addition, students can be accepted as direct admits if they meet SAT or ACT score minimums and have a high school GPA of 3.4 or higher. Graduates from this program go on to become business intelligence analysts and clinical data managers.

• Location: Phoenix, AZ
• Duration: Two to four years
• Accreditation: Higher Learning Commission (HLC)
• Tuition: $714 per credit

Southern New Hampshire University offers an online bachelor’s degree in data analytics that teaches students to create data sets that meet organizational goals. This program emphasizes tools such as Python, SQL, and Tableau and R, which scripts, manipulates, and visualizes statistics for analysis.

Courses in this 120-credit program include emerging technologies and big data, single-variable calculus, gathering requirements and collecting data, and applied statistics. In addition, students in this program can choose to earn a concentration in project management for STEM, which explores real-life scenarios in data analytics administration.

• Location: Manchester, NH
• Duration: Four years
• Accreditation: New England Commission on Higher Education (NECHE)
• Tuition: $330 per credit

Drexel University’s nationally-ranked College of Medicine offers two fully online programs in clinical research management. The post-bachelor’s clinical research certificate is 15-credits and is designed for a wide range of professionals to earn clinical research credentials to move into a new career. Students can complete this online program in one to two years, and students can choose to apply these credits towards a master’s of science in clinical research organization & management. Applicants must already have a bachelor’s degree.

The master’s of science in clinical research organization & management is a fully-online 36-credit graduate-level program ideal for experienced clinical research professionals wanting credentials and management skills. The curriculum is customized for each student to meet specific career goals, and industry experts teach courses. This program can be completed in two to three years and lead to a career in clinical data management.

• Location: Philadelphia, PA
• Duration: One to three years
• Accreditation: Middle States Commission on Higher Education (MSCHE)
• Tuition: $1,255 per credit

Certificate and degree programs in CDM offer coursework in computational tools for clinical research, clinical trials management, applied biostatistics in clinical trials, and drug development from discovery to commercialization.

Master’s programs are focused on clinical research as a whole with the following specializations and coursework:

Specializations

• New product research and development
• Regulatory compliance, ethics, and law
• Biostatistics and data management
• Clinical research management and safety surveillance
• New therapeutic product business and strategic planning

Coursework

• Business processes and contemporary concerns in pharmaceutical R&D
• Worldwide regulatory submissions
• Introduction to clinical trials
• Introduction to clinical pharmacology
• Ethical issues in research
• Medical device combination product regulation
• The history of misconduct in biomedical research
• Current issues in review boards
• Current federal regulatory issues in biomedical research
• Patient recruitment and informed consent
• Pharmaceutical law
• International regulatory affairs
• Compliance and monitoring issues
• Contemporary issues in human research protection
• Quality assurance audits
• Epidemiology
• Applications of clinical research biostatistics
• Clinical data management
• Designing the clinical trial
• Health policy and economics
• Clinical outsourcing

The Society for Clinical Data Management (SCDM) produces the Good Clinical Data Management Practices (GCDMP) guidelines outlining the standard of practice in the field. Last revised in July 2009, this document guides CDM professionals on the best practices that align with regulatory procedures.

SCDM also administers the International Association for Continuing Education and Training (IACET) accredited certification program for clinical data managers, online and in-person educational opportunities, and career resources for job-seekers and employers.

The Association for Clinical Data Management (ACDM) has been operating for 30 years. In addition to hosting annual conferences, the association offers online training, resources, and professional development for those involved in all aspects of clinical data management in the pharmaceutical, biotechnology, and academic research. The ACDM website also has a job board where corporate members can post CDM employment opportunities.

Rachel Drummond, MEd

Writer

As a contributor on MHAOnline, Rachel Drummond has brought her expertise in education and mindfulness to the healthcare management field since 2019. She writes about integrating innovation into healthcare administration, emphasizing the importance of mental and physical well-being for effective leadership and decision-making in the fast-paced world of healthcare management.

Rachel is a writer, educator, and coach from Oregon. She has a master’s degree in education (MEd) and has over 15 years of experience teaching English, public speaking, and mindfulness to international audiences in the United States, Japan, and Spain. She writes about the mind-body benefits of contemplative movement practices like yoga on her blog, inviting people to prioritize their unique version of well-being and empowering everyone to live healthier and more balanced lives.