A Clinical Data Management system or CDMS is a tool used in clinical research to manage the data of a clinical trial.
The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS.
The CDMS can be broadly divided into paper-based and electronic data capturing systems.
Clinical Data Management system
Clinical data management (CDM) 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.
Regulatory Affairs Courses in
Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, and complementary medicines, and by the companies responsible for the discovery, testing, manufacture, and marketing of these products wanting to ensure that they supply products that are safe and make a worthwhile contribution to public health and welfare.
Regulatory affairs officers ensure that products such as cosmetics, pharmaceuticals, and veterinary medicines meet legislative requirements.
Key duties of the job include:
studying scientific and legal documents. gathering, evaluating, organizing, managing and collating information in a variety of formats.
Program Duration: Two Month, Daily 2Hrs
Module 1 Introduction to Pharmacovigilance
Module 2 Regulatory Guideline in Pharmacovigilance
Module 3 Causality Assessment and Expedited Reporting