Sciences Procedural Outline of Clinical Data Management Under Clinical Research Trials

Abstract

Clinical data management is a systematic informative process to generate high quality data that gets converted into information and knowledge essential for decision making [1]. The importance of CDM is highlighted initial role to ensure sufficient integrity in valid results and conclusions with high quality standards that in-turn helps in review and approval of new drugs by regulatory agencies that trust clinical trials. So, rigorous training is induced for all key players involved in clinical trials. Hence, clinical data management is a critical task for collection, integration and validation of clinical trial data [2]. The end result of CDM is to provide a study database that is accurate, secure, reliable and ready for analysis. It accelerates the timeline from data collection to analysis [3]. Multidisciplinary team should be well versed from stage of inception to completion with CDM process under high quality standards. The principle of ICH GUIDELINES, GCP describes that clinical trials should be scientifically sound and should have clear, detailed protocol in the form of data management plan or statistical analysis plan. ICH is a joint venture by both regulators and industry as equal partners in scientific and technical discussions of testing procedures to ensure and assess the safety, quality and efficacy of medicines [1]. The primary objective of CDM is to provide high quality reliable data for randomized controlled trials in line with good clinical practices. These trials are conducted according to GCP standards to ensure internal and external validity with CDM conducted by team members [4]. The procedure under CDM includes development of case report form, CRF designing CRF annotation, data designing, data entry, data validation, discrepancy management, medical data coding, data extraction and database locking [5]. Regulatory compliant data management tools like Open Clinica and QMS PLUS are available for substantial reduction in time and error between the data entry and database locking. It is becoming mandatory for companies to submit electronic data through EDC (Electronic Data Capture) [6]. This review article would focus on the procedure, tools and standards adopted as well as the roles and responsibilities of key players of CDM process.