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.
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.
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!