Clinical Data Management is a systematic approach to collect, organise and manage the large amount of the clinical information in compliance with regulatory guidelines and SOPs provided by the sponsors.
Large amount of info generated in clinical studies is tedious to handle manually as it requires lot of expertise and manpower. The solution to this problem is to use electronic tools which can easily handle a huge amount of work with no time lag. Such tools used by the clinical expertise personnels are termed as CDMS. CDMS stands for clinical data management system which provides high quality info arrangement solution by reducing or minimizing the chances of error and missing data.
In order to achieve high end data, CDM uses software that completes, updates, processes and stores the crude data in the databases for further analysis. These softwares also facilitate the maintenance of audit trials by providing easy resolutions and identification of data discrepancies.
Clinical data management softwares are updated and validated systems which implement step to step methods and contribute in finalization and review of the study protocol, database designing and system validation, infomation collection, CRF tracking, data entry, validation of info, discrepancy management, medical coding and database locking.
Innovations that are now been introduced to CDM worldwide have enabled the researchers to manage and conduct large and complex clinical trials with ease. CDMS tools are commercial but some are also available widely as open sourced. They are more or less similar in the function and there is not much significance of one over the other.
Data of the patient is usually collected in the paper/digital CRF at investigator site, whose entries are viewed, monitored and validated by the CRA (Clinical Research Associate). Thus, CRF is used as first step in translation of protocol activities.
Clinical study data collection through paper CRF is then translated to the databases in the form of electronic CRF. Data entry from paper CRF to the system is done by CDM personnel for updating eCRF databases. CRF is then further retrieved and forwarded to the CDM team where CDM personnel perform CRF tracking and archive it for analysis and future records. System validation is another important step in CDMS which is used to ensure the system specifications and data security. Subsequent steps include data validation through which data is tested in accordance to the specifications of protocol.
To identify the discrepancies in the entered infomation; program edit checks are written and fed into the databases to ensure validation of the data. Review and queries (DCF) are then communicated by the CDM team to the investigator team and resolution of the data queries, answered by investigator side is retrieved, implemented and archived finally for statistical analysis through databases. After a thorough check on quality and assurance, databases are finalized and locked, which is the final step of clinical data management.