Training
data-management

Clinical Data Management

$500.00 Including TaxesEnroll

This is a Live Course where the classes will be conducted on a specific timing, by an instructor, on web meeting. The details of the course will be sent you  sent to your registered email ID. For any other specific questions, you can reach us at training@pvrtech.com.

Category:

Program Description

Topics covered in this program.

Introduction

– What is Clinical Trials
– Phases of Clinical Trials
– ICH guidelines for Good Clinical Practice
– SOP Development
– Communication with Cross functional teams
– Introduction to Clinical Protocol

 

Clinical Data

– What is Clinical Data Management (CDM)
– Good Clinical Practice (GCP)
– Data Management(DM) Plan
– Clinical data and its Quality
– CDM Systems
– Clinical Data Repositories
– Loading the external data into the CDM system
– Exporting of data to CDM
– Query Management

 

Data Source and Formats

– Data Clarification Form
– Patient Diary and Patient reported outcome
– Remote Data Entry
– Clinical data entry – Single entry, Double entry, SAE Reconciliation, Coding of Adverse Events
– Data Cleaning and Data Validation
– Elements of CRF
– e-CRF designing, Data tracking from CRF

 

Outputs

– Types of Reports generated
– Database locking
– Clinical Data Archiving

 

First Day of Work

– What to expect on First Day?

– What to ask and what not to ask?
– Connecting to Systems and Navigating
– Adding things in Favorite for faster retrieval
– Understanding the terminologies used

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