Clinical Data Management

Categories: Pharma IT
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About Course

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. Clinical data management ensures collection, integration and availability of data at appropriate quality and cost.

Overall, clinical data managers are responsible for collecting data from a variety of medical research projects, such as clinical and pharmaceutical trials. They work collaboratively to make sure data is collected, managed and reported clearly, accurately and securely.

There is massive career development in clinical data management. Candidates have tremendous career development in CDM. There is a great deal of job opportunity in this field, and it has even more economic advantages.

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Course Content

ROLE OF THE CLINICAL DATA MANAGER IN A CLINICAL TRIAL

  • ROLE OF THE CLINICAL DATA MANAGER IN A CLINICAL TRIAL

STANDARD OPERATING PROCEDURES

DATA MANAGEMENT PLAN

CASE REPORT FORM DESIGN

DATABASE DESIGN AND BUILD

VALIDATION RULES

USER ACCEPTANCE TESTING

DATA ENTRY

DATA VALIDATION

DATA QUERIES

CENTRAL LABORATORY DATA

SERIOUS ADVERSE EVENT RECONCILIATION

PATIENT RECORDED DATA

DATABASE FINALISATION AND EXTRACTION

METRICS AND TRACKING

QUALITY CONTROL

PROFESSIONAL ORGANISATIONS FOR CLINICAL DATA MANAGEMENT

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