A crucial stage in clinical research is clinical data management (CDM), which produces high-quality, trustworthy, and statistically sound data from clinical trials. This results in a significantly shorter period of time between drug development and release. From the beginning to the end of a clinical trial, CDM team members are actively involved. They must have sufficient process knowledge to support upholding the CDM processes high levels of quality. At regular intervals throughout a trial, various CDM processes-including Case Report Form (CRF) designing, CRF annotation, database designing, data entry, data validation, inconsistency management, medical coding, data extraction, and database locking are evaluated for quality. To meet regulatory requirements and stay ahead of the market through quicker product commercialization, there is a greater need to strengthen CDM standards in the current environment. The CDM team can achieve these requirements by implementing regulatory-compliant data management technologies. Additionally, submitting data electronically is becoming required of businesses. Professionals in CDM should have the drive to keep up with the fast evolving technology, satisfy reasonable requirements for data quality, and fulfil reasonable expectations.
Published Date: 2022-08-31; Received Date: 2022-08-04