Clinical Data Management – A Process of clinical Research

Clinical Data Management – A Process of clinical Research is a process in clinical research, where it leads to the generation of high-quality, reliable, and statistically sound data from clinical trials. Clinical Data Management plays a crucial role in the data collection phase of clinical research and it is the process of collecting and managing research data is done in accordance with regulatory standards to obtain quality information that is complete and free from error.
Clinical Data management ensures collection, integration, and availability of clinical data at appropriate quality and it also supports conducting, manages, and analysis of studies across the spectrum of clinical research. The field of clinical data management (CDM) has come about due to the requirement from both the pharmaceutical industry and the regulatory authorities for the development of pharmaceutical products to continue to accelerate, regulatory entities by requiring quality-assurance standards to be met in collecting the data used in the drug evaluation process.

Such standards are created by the Clinical Data Interchange Standards Consortium (CDISC), are particularly vital to CDM, the Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG) and the Clinical Data Acquisition Standards Harmonization (CDASH).

The former one is currently mandated for use by the U.S. Food and Drug Administration (FDA) and the latter created a standard format for collecting data across studies so that data submissions can be more easily traced and reviewed. Specialized tools are used in CDM to create audit trails that allow the discrepancies should be minimized even in large and complex clinical trials.

Clinical data management systems (CDMS) are especially vital in clinical trials conducted across medical centers in which a huge amount of data is produced. Examples include Oracle Clinical, rave, eClinical suite, Clintrial, and Macro. The clinical data manager plays a key role in the setup and conduction of a clinical trial where the data collected during a clinical trial forms the basis of subsequent safety and efficacy.

The analysis which in turn leads to decision making on product development. The clinical data manager is also involved in early discussions about data collection sources and then oversees the development of data collection tools based on the clinical trial protocol.

The computer systems used in the processing and management of clinical trial output data must undergo validation to ensure that they perform as intended and that results are reproducible.