There are several key members of the Clinical Data Management (CDM) team. Among the specialists on the CDM team are people who will check and analyze all of the clinical report form (CRF) data entered into the EDC. One of the main goals is to minimize errors and missing data. In general, clinical data management responsibilities fall into 5 primary roles.
Clinical Data Management Responsibilities Explained
CDM team members should have a bachelor’s degree in life science and must have solid analytical and computer skills:
1. Data Manager
The data manager oversees the whole CDM process. The data manager approves the CDM procedures and ensures that all internal documents about CDM activities are correct. The data manager also must ensure that team members have access to the database.
2. Database Designer
The database designer annotates the Case Report Form (CRF), forms the study database, and the edit checks for validating the data. They are also in charge of designing the screens for data entry and ensuring that edit checks work with dummy data.
3. Medical Coder
A medical coder will code for things like co-illnesses, medical history, adverse events, and concomitant medications that people took while participating in the study.
4. Clinical Data Coordinator
The clinical data management responsibilities of clinical data coordinator in another important member of the CDM team. The clinical data coordinator is in charge of making the CRF and its instructions and dealing with discrepancies. The clinical data coordinator also makes other CDM-related checklists and documents.
5. Quality Control Associate
The quality control associate ensures correct data entry and data auditing. This role also requires checking the documentation for the procedures used.
6. Data Entry Associate
A data entry associate will keep track of the receiving of CRF pages and enter the data into the database.
Clinical Data Management Responsibilities Summary
Key players in the CDM team can work well with advanced clinical data management software. Clinical Pursuit provides the latest EDC clinical trial software and data management systems to our valued customers, in addition to offering modern electronic patient-reported outcome (ePRO) solutions.
Contact us to benefit from our EDC and streamlined clinical trial data management services.