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

 Clinical Research:

Here We are going to see the following:

1.Clinical Research process

:  Divided basically into Phases

•  Pre-Clinical
• Phase I  
•   Phase II
•   Phase III
•    Phase IV.

• 2. Clinical Research Organizations:

• Introduction and Role of Key organizations involved in Approval and Monitoring of  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.

• 3. Structure of Clinical Trial:

• 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).

Clinical Data Management(CDM):

In CDM we are going to study in depth process of  Data Management right from beginning of creating Data management plan(DMP) till the end of database closure and data archiving.

•  Data Management Plan(DMP):

which contains All the details of Data Management Process.

• Designing CRF and Electronic Data Capture:

CRF is a data collection instrument, CRF design ensures quality data, avoid data redundancy, Minimizing errors by coding. Electronic Data Capture is done using EDC Tools such RedCap, Oracle Clinical, RAVE etc.

• Trial Database Set Up:

It is done to Ensure ease and speed of Data entry, Prevention of Errors, Efficient Creating of Datasets , Following GCP.

• Validation Checks:

It includes Missing Values checks and Range checks, done to avoid data inconsistencies.

• Training:

Qualified and Trained Personnel are required as per GCP.

• Data Collection:

Done by Paper CRF Manually or e-CRF

• Data Processing:

Includes Data Receipt, Data Review, Data coding, Data Entry, Data Validation and Query Management.

• Monitoring data Quality:

Includes Progress Reports, Site Monitoring, Auditing

• Monitoring Safety:

Includes Adverse Event Reporting and Data safety Monitoring Board

• Audit Trail:

Documentation changes are recorded.

• Database Closure:

Prevents Unauthorised changes to data.

• Data Storage:

Store Clinical Data, Making BackUp copies, Minimizing Data corruption ,Accidental or Intentional Manipulation of Data.

• Security and Confidentiality:

Restricting Access to subject identifying data.

• Data Archive:

Archiving Clinical Data in a secure and stable areas

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!