Clinical data management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. Clinical data management assures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). The ultimate goal of CDM is to assure that data support conclusions drawn from research. Achieving this goal protects public health and confidence in marketed therapeutics.
Course Duration: 165 Hours
ROLE OF THE CLINICAL DATA MANAGER IN A CLINICAL TRIAL
Job profile acceptable in CDM: clinical researcher, clinical research associate, clinical research coordinator etc. The clinical data manager plays a key role in the setup and conduct of a clinical trial. The data collected during a clinical trial forms the basis of subsequent safety and efficacy analysis which in turn drive decision making on product development in the pharmaceutical industry. The clinical data manager is involved in early discussions about data collection options and then oversees development of data collection tools based on the clinical trial protocol. Once subject enrollment begins, the data manager ensures that data is collected, validated, complete, and consistent. The clinical data manager liaises with other data providers (e.g. a central laboratory processing blood samples collected) and ensures that such data is transmitted securely and is consistent with other data collected in the clinical trial. At the completion of the clinical trial, the clinical data manager ensures that all data expected to be captured has been accounted for and that all data management activities are complete. At this stage, the data is declared final (terminology varies, but common descriptions are “Database Lock” and “Database Freeze”), and the clinical data manager transfers data for statistical analysis.
CONTENTS AND OVERVIEW
This course is designed to introduce the concept of clinical data management and data management activities for beginners in healthcare industry .
- Section 1 starts with an overview of clinical data management,discussing what is clinical data management and regulations,standards implemented in CDM.
- Section 2 outlines CDM process,data management plan and describe activities involved in different phases of data management.
- Section 3 gives an overview of variable tools used in CDM and key members involved in CDM team with their responsibilities
At the end of the course,you will able to
- Understand clinical data management and it’s role in clinical research
- Describe activities involved in CDM process
- Demonstrate functions of key members in CDM and variable tools available for CDM