Multidisciplinary cooperation in multi trial centers needs an organized data management, configuration to ensure true progress monitoring and high quality research data. So, that Clinical Data Management (CDM) is an essential tool in the medical study, leads to produce high-quality, reliable, and statistically significant data from multiple clinical trials and diminish time phase of drug development to marketing. CDM’s members are extremely active during all stages of clinical trial or drug development, from inception to completion and maintain the quality standards of CDM processes On the other hand, multiple procedures in CDM, including Case Report Form (CRF) designing, CRF annotation, database designing, data-entry, data validation, discrepancy management, medical coding, data extraction, and database locking are assessed for quality at regular intervals during a multi centric clinical trial. Presently, CDM is becoming compulsory for drug development companies to submit the data electronically. This review article spotlight on the processes involved and provides the reader an overview of the tools and protocols adopted as well as the roles and responsibilities in CDM.
Key Words:- Clinical data management; data management; Multi centric trial; Good clinical data management practices.
Multi-center clinical trial (MCCT) is a group of several discipliner, deliberated to find answers to the research question by means of generating data for proving or disproving a hypothesis and performed at many clinic center. Most large clinical trials, particularly Phase III trials, are conducted at different clinical research centers. MCCT include a larger number of participants, different geographic locations, the possibility of inclusion of a wider range of population groups, and the ability to compare results among centers, all of which increase the generalizability of the study. In various cases, efficacy will vary significantly between population groups with different genetic, environmental, and ethnic. It is very important to generate quality data to evaluate the benefit of therapies for the treatment of disease, therefore, MCCT needs a formalized data management structure to ensure true progress monitoring and high quality research data, consequently, MCCT require such a computerized tools i.e. Clinical Data Management (CDM) involve in organizing and managing of the different clinical data, generated from multidisciplinary collaboration. clinical data gathered at the investigator site in the case report form (CRF) are stored in the CDMS and to reduce the possibility of errors due to human entry, the systems employ various means to verify the data. CDM can be self-contained or part of the functionality of a CTMS (clinical trial management system). A CTMS with clinical data management functionality can help with the validation of clinical data as well as the help the site employs the data for other important activities (building patient registries and assist in patient recruitment efforts) [1-2].
CDM is a very applicable and essential part of an any type of clinical trial (fig-1). It is a multidisciplinary activity, including research nurses, clinical data managers, investigators, support personnel, biostatisticians and database programmers. Presently, CDM is highly accepted that the design, implementation, coordination and analysis of clinical trials require a multidisciplinary specialist approach .
CDM have several responsibilities from the handling of data to finish with data management or information. During course of work CDM have followed given protocol – to be collected or analyzed along with database design, design of electronic case report forms (CRFs), recruiting patients, collection of data, and statistical analysis .