This course provides an easy understanding of clinical data management and processes involved for generation of high quality clinical trials data that helps in faster commercialization of product
Learn Basics Of Clinical Data Management With This Comprehensive Course
Get familiar with Clinical data Management
Learn Phases & activities in CDM
Identify tools & roles in CDM
Master to manage clinical data by CDM activities
Clinical Data management is essential to the overall research function,as its key deliverable is the data to support the submission.
CDM has evolved in response to the ever-increasing demand from pharmaceutical companies to fast-track the drug development process and from the regulatory authorities to put the quality systems in place to ensure generation of high-quality data for accurate drug evaluation.
Contents and overview
This course is designed to introduce the concept of clinical data management and data management activities for beginners in healthcare industry covering 24 video lectures with 2 hours content & 2 end of module quizzes.
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 what is clinical data management & it's role in clinical research
Get an overview and understand the regulations,guidelines & standards implemented in CDM
This assessment tests your knowledge on topics covered in Clinical Data Management Overview module
Understand the process of Clinical Data Management
Understand Data Management Plan and it's scope
You will get an overview of study start up phase & it's activities
Understand CRF and it's design considerations
Understand Clinical Database structure & design
Get familiar with types of validation checks & their role in CDM
Understand the considerations in clinical database setup & testing
You will get an overview of study conduct phase & it's activities
Get to know data entry & methods in CDM,explaining it's role
Get an overview of discrepancy management & types of discrepancies
Understand medical coding and it's methods
Understand the process of SAE reconciliation and steps involved in CDM
You will get an overview of study close out phase & it's activities
Get an overview of QC activities in CDM
Get familiar with database lock & it's activities
Understand what components are archived and purpose of electronic archival
This assessment tests your knowledge on topics covered in Clinical Data Management Process & Activities module
Get familiar with various free & commonly used tools in CDM
Understand the roles & responsibilities of key members in CDM team
With over 2+yrs of cross-functional experience across various industry verticals,got expertise with
1. Writing SAS programs to generate tables, listings, and figures and analysis datasets.
3. Knowledge of clinical and pharmaceutical drug development and associated ICH/GCP guidelines
4. Converting the legacy data into CDISC-SDTM data standards
5.Experience of extracting,manipulating,summarizing,analyzing and presenting data using SAS procedures