Clinical data management (CDM) is the process of collection, cleaning and management ofclinical trial data in accordance with regulatory standards to obtain quality information that is complete and error-free. The goal is to check the data compliance and ensuring that the data collected during a clinical trial is Accurate, complete, logical, consistent as per GCP, CRF, Protocol and as per study documents. The field of clinical data management (CDM) hasdemands from both the pharmaceutical industry and the regulatory authorities. Data reviewed will submitted to regulatory authorities for approval and marketing.

To maintain data integrity, the CDM process starts at the start of a clinical trial, even before the study protocol is finalized and participate in kick-off meetings. The CDM team designs a case report form (CRF) and defines the data fields and checks the data compliance. CRFs specify the data type to be collected, the units of measurement, and CRF completion guidelines. CDASH principles used for designing CRF. 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, many pharmaceutical companies have adopted remote data entry or e-CRF as a time-saving measure.

Various documents will be prepared by Data Managers, aData Management Plan (DMP) is a document that describes how clinical data will be handled during the course of the study. This guide, includes a description of the trial’s CDM activities study setup, CFR tracking, data entry, validation, discrepancy management, vendor reconciliation, medical coding, database locking and archival of clinical data are subsequent steps in the process.