Clinical Research and Clinical Data Management:

• Clinical research is a branch of healthcare science that determines the safety and efficacy of medications, devices, diagnostic products and treatment regimens intended for human use.
• Clinical Data Management(CDM): is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials.It ensures collection, integration and availability of data at appropriate quality and cost.

COURSE STRUCTURE

In Clinical Research We are going to study the following:

• Clinical Research process:  Divided basically into Phases  Pre-Clinical, Phase I,

    Phase II, Phase III, Phase IV.

• Introduction and Role of Key organizations involved Approval and Monitoring  Clinical Trials such as IRB/IEC,ICH and FDA.
• Introduction to Sponsor and CRO(Contract  Research Organization)involved in Arranging and Managing the Clinical Trials.
• Introduction and Role of Investigator who is the head of Research team.
• Description of Investigator Brochure.
• Description of Clinical Trial Design which may be Parallel or Cross-Over designs.
• Details of Clinical  Trial Protocol which enclosed basic and complete plan of the study.
• Details of Randomization process which include the information of assigning subjects to different groups.
• Designing and capturing data in Case Report Form(CRF).

In Clinical Data Management we are going to study

In CDM we are going to study:

• Electronic Data Capture.
• Creating Database, Database Validation ,Programming and Standards.
• Data Entry Process.
• Data Storage.
• Medical Coding Dictionaries(MEDDRA).
• Safety Data Management And Reporting
• Serious Adverse Events Data Reconciliation
• Database Closure or Database Lock.

CERTIFICATION

Upon successful completion and Assesment through tests and practices certificate will be provided.

Now it’s time to check out of this course. Have fun!