Clinical data management (CDM) is the process that involves collecting, cleaning, and managing subject data in compliance with predefined study requirements and regulatory standards.
Data life cycle
The data life cycle in clinical research involves several key stages.
| Data life cycle | Description | Stage of a study |
|---|---|---|
| Data planning | Defining data requirements. Developing data management plans (DMP). Setting up data standards. | Planning of a study |
| Data collection and storage | Collecting clinical data from study participants. Securely storing data in databases, ensuring data integrity and compliance with standards. | Ongoing |
| Data cleaning | Identifying and correcting errors, inconsistencies, and missing values to ensure data quality and consistency. | Ongoing / End of study |
| Data analysis | Analyzing the cleaned data to generate answers to study objectives. | Ongoing / Closure of study |
| Data reporting | Preparing study results for submission to regulatory authorities or publication. | Closure of study |
| Data archiving | Long-term storage of data for future reference and regulatory compliance. | Closure of study |
Data management tools
Clinical Trial Management Systems (CTMS)
CTMS is a software solution focused on managing the overall trial process, including scheduling, tracking, and administrative tasks.
Case Report Forms (CRFs)
A CRF is a standardized form used to collect data from each study participant, which is then used for analysis.
Electronic Data Capture (EDC) systems
EDC is a digital platform that facilitates the electronic entry, validation, and management of clinical trial data.
Differences between CRF and EDC
The eCRF refers to a system used to capture clinical data for research, while EDC refers to the generic process of data capture [1].
See also
Another relevant pages
Links to this page
- Independent data-monitoring committee (← links)
- Sponsor (← links)
- Standard operating procedures (← links)
- Sub-investigator (← links)
- Subject identification code (← links)
- Well-being (← links)
References
- ↑ Rorie DA, Flynn RWV, Grieve K, et al. Electronic case report forms and electronic data capture within clinical trials and pharmacoepidemiology. Br J Clin Pharmacol. 2017;83(9):1880-1895. doi:10.1111/bcp.13285 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5555865/ Accessed Jul 2024
External links
- Oronsky, Bryan et al. Data Management 101 for drug developers: A peek behind the curtain. Clinical and translational science vol. 16,9 (2023): 1497-1509. doi:10.1111/cts.13582 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10499417/ Accessed Nov 2023
- NCI Thesaurus (NCIt) controlled terminology, Data Management (Code C18086), https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&version=24.05d&ns=ncit&code=C18086&key=1254648001&b=1&n=null Accessed Jul 2024