What is Clinical Data Management (CDM)?
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.
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 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) and the Clinical Data Acquisition Standards Harmonization (CDASH). The former is currently mandated for use by the U.S. Food and Drug Administration (FDA). The latter created a standard format for collecting data across studies so that data submissions can be more easily traced and reviewed.
Specialized tools (i.e., software applications) are used in CDM to create audit trails that allow discrepancies to be minimized even in large and complex clinical trials. Clinical data management systems (CDMS) are especially vital in trials conducted across medical centers in which an enormous amount of data is produced. Examples include Oracle Clinical, rave, eClinical suite, Clintrial, and Macro.
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. 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. The Code of Federal Regulations (CFR), 21 CFR Part 11 provides the compliance standards to which CDM systems must adhere.
How Does Clinical Data Management (CDM) Work?
To maintain the integrity of data, the CDM process starts at the very beginning 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 to be utilized. CRFs specify the type of data to be collected, the units of measurement to be used, and CRF completion guidelines (i.e., instructions for filling in data). Variables are annotated using coded terms.
A data management plan (DMP) is then developed as a guide, including a description of the trial’s CDM activities. Databases are built to support CDM tasks with corresponding compliance tools. 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, remote data entry or e-CRF has been adopted by many pharmaceutical companies as a time-saving measure.
What Roles Are Involved in CDM?
CDM requires a variety of roles and responsibilities of team members and take 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 coordinator – 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 Data Management Certification
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 receiving validation of one’s skills and expertise, earning certification comes with a variety of organizational benefits such as 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 afore-mentioned criteria
Applicants do not need to be members of the Society for Clinical Data Management, nor do they need to 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 90 days from the date stated on their acceptance letters to take the exam. A variety of materials are offered by SCDM to assist candidates in preparing.
Clinical Data Management Degree Programs
The desired requirement for clinical data managers is an undergraduate degree in life sciences and knowledge of 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.
Ideally, medical coders are med-tech program graduates, but paramedical and other healthcare professionals may be recruited 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 organization and management
- Doctor of nursing practice (DNP)
- Doctor of philosophy (PhD) in clinical research
Clinical Data Management Coursework & Specializations
Certificate programs in CDM offer coursework in areas such as 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:
- 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
- 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
- Applications of clinical research biostatistics
- Clinical data management
- Designing the clinical trial
- Health policy and economics
- Clinical outsourcing
Associations & Resources for Clinical Data Management
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 practice.
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 both job-seekers and employers.
The Association for Clinical Data Management (ACDM) has been operating for the past 30 years. In addition to hosting annual conferences, the association offers training, resources, and professional development for those involved in all aspects of clinical data management in pharmaceutical, biotechnology, and academic research. The ACDM website also has a job board where corporate members can post CDM employment opportunities.