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Topic 1 : Introduction to Clinical trials
Topic 2 : Why Cant we submit the data to FDA as it is?
Topic 3 : Role of CDM in the CT process
Topic 4 : Overview of CT and CDM
Topic 5 : Indroduction to CDM process
Topic 6 : Study Step activities
Topic 7 : Study Conduct activities
Topic 8 : Study Closeout activities
Topic 9 : Clinical trial process : Preclinical trials
Topic 10 : INDA Application
Topic 11 : Designs of Clinical trials
Topic 12 : Phases of the Clinical Trials
Topic 13 : NDA Application
Topic 14 : CRF Indroduction
Topic 15 : CRF contents
CDM Trainer Introduction.
Glossary of Clinical Trials.
What are clinical trials?
Why we need clinical trials?
what is the Clinical Trial Process?
what is Clinical Trial Phases?
What is Clinical Data Management (CDM)?
What is Data capture?
what is data entry?
what clinical manager do?
Clinical Data management Overview.
Objectives of clinical data management.
Interdependent groups in CDM.
CDM Activities Phase wise.
different roles and responsibilities in the study setup?
Different clinical Data management systems.
Clinical data managers' salaries.
Question and answers?