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Updated on Friday, August 14th by Seth Preston.
Recently, our Clinical Data Management team has been growing! Here at Trial Runners, having the right people in the right place is one of our keys to success in clinical research, and Clinical Data Management is no different. While remaining just a portion of our services, our experienced data management team ensures accurate databases, proper records, and is a key-player in trial success. So what exactly does our team deal with? What roles make this team? Our Clinical Data Management team took a short break to discuss this and more.
What is Clinical Data Management?
Clinical Data Management (CDM) is an essential part of the data collection phase in clinical research. This key-component’s purpose is to organize clinical trial data into a database that completely and accurately reflects the findings and events of the trial ensuring validated data is available for analysis.
CDM is critical in establishing the process for collecting and managing data with the ultimate goal of maintaining data integrity and producing a high-quality database for analysis. CDM’s primary deliverables are Case Report Form (CRF) Development, CRF Completion Guidelines, Data Management Plan, Medical Coding, Database Development, Listing Reviews, Query Management, and ultimately archival of the study database.
What Roles Are Involved In CDM?
CDM requires a variety of roles and responsibilities of team members and take the form of:
- Data manager – serves as the functional team lead for CDM and oversees all deliverables on a project, including but not limited to database development, query management, data reviews and database lock.
- 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 – performs coding of adverse events, medical history, and concomitant medications to further categorize study data for analysis.
- Clinical data associate – designs the CRF, prepares the filling instructions, develops discrepancy protocols, participate in query management process, tracks the completion of CRF pages, and enters data into the database (for paper-based studies)
What Standards Are Vital To CDM?
Two standards created by the Clinical Data Interchange Standards Consortium (CDISC), are particularly vital:
- The Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG) – mandated for use by the U.S. Food and Drug Administration (FDA)
- Clinical Data Acquisition Standards Harmonization (CDASH) – a standard format for collecting data across studies so that data submissions can be more easily traced and reviewed.
The Society for Clinical Data Management (SCDM) has created a comprehensive document that provides guidance on accepted practices of clinical data management (CDM) that are not totally covered by current guidelines and regulations. This document is entitled Good Clinical Data Management Practices (GCDMP) and updated by Subject Matter Experts on a continuous basis.
What Systems And Tools Are Used In CDM?
Clinical data management systems (CDMS) are especially vital in trials conducted across medical centers in which an enormous amount of data is produced. Case report forms are used as the primary method of collecting data either by paper or electronic means; however, as technology has continued to evolve, the use of paper CRFs is very limited and the industry commonly uses electronic CRFs where sites enter the data directly into the CDMS. Examples of CDMS include the following: iMedNet, Medrio, Oracle Clinical, Medidata Rave, Clintrial, and OpenClinica.
Trial Runners has 2 in-house CDMS solutions: Medrio and iMedNet, although Medrio is our recommended system for Sponsors that need a solution because of the easy interface and preference for this system by sites. Alternatively, Trial Runners sells adaptability which is why our CDM team will work with any system the client prefers whether they have another database vendor or their own in-house solution! In cases where the Sponsor has their own in-house CDMS, our team is able to operate in line with the functional service provider (FSP) model and work under their system processes.
Clinical Data Management plays a key part in the success of many clinical trials. Proper data management ensures accuracy, maintains regulatory standards, and ultimately plays a key role in determining the outcome of clinical studies.