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Clinical Data Management

With this online /in-person practical training, you will be able to apply for Clinical Data Management positions including:

S.no Theoretical Training
1
Introduction to Clinical Research, Roles & Responsibilities of Key Stakeholders
2
Preparations, Planning for Clinical Trials and Essential Documentation in Clinical Research & Regulatory Submissions
3
Clinical Data Management Process / Workflow
4
CRF Design & Design Considerations
5
Data Management Plan
6
Paper based and Electronic / Remote studies
7
Electronic Data Capture
8
Identifying and Managing Discrepancies
9
Tracking CRF Data
10
Managing Lab Data
11
Collecting Adverse Event Data
12
Medical Coding (MedRA, WHODD)
13
Creating Reports and Transferring Data
S.no Practical Training using Clinevo EDC
1
Clinevo EDC Overview
2
CDM Process and how a Clinevo EDC maps to CDM process
3
Study Build:
a. Global library management including creation of Domains, Questions etc.
b. Database build and Entry screen design
c. Medical Coding Setup
d. Edit Check Programming and Lab ranges setup
e. Testing and releasing to Production
4
Study Conduct:
a. Data entry
b. Discrepancy management
c. Medical Coding (MedRA, WHODD)
d. Source Data verification and Data Reviews
5
Study Closeout:
a. Data Lock and Freeze
b. Data Export

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