Basic of Clinical Data Management

Name: Basic of Clinical Data Management
Rating: 4.2 (456 reviews)

Clinical Data Management

Created bySurabhi Jain

Last updated 1/2020

English

What you'll learn

After enrolling for the course, you will learn about the basic of clinical data management. This course includes lots of examples on how a clinical data manager works. The course covers the topics right from the protocol review, CRF preparation to the database lock activities.

Course content

1 section • 11 lectures • 1h 23m total length

Introduction of Clinical Data Management-4:01
Learn how clinical data management ensures high quality, reliable data by overseeing data collection and cleaning, ensuring completeness, consistency, and compliance with good clinical practice throughout clinical trials.
Module 1- Clinical Data Management Basics8:24
Discover core clinical data management practices, including data collection and cleaning per the protocol, and uphold the three c's: complete, consistent, and compliant.
Module 2 Clinical Trial Phases in Clinical Data Management clinlearn7:35
Explore how clinical data management divides a trial into initialization, execution, and closure, covering study setup, conduct, close-out, protocol, standard operating procedures, vendor audits, data collection, cleaning, and data lock.
Module 3 Case Report Form clinlearn12:56
Learn how to design and review case report forms (CRFs) in clinical data management, align CRFs with the protocol, specify data fields, and compare offline and online CRF workflows.
Module 4 Clinical Data Management System clinlearn11:46
Prepare and program clinical data management systems, covering offline and online CDM design, database programming, and automated edit checks to ensure protocol-aligned data.
Module 5 Data Entry clinlearn3:46
Learn how clinical data management handles data entry from source documents to electronic capture, using double data entry, source data verification, and site monitoring to ensure accurate data in ECF/EDC.
Module 6 Data Cleaning clinlearn15:58
Learn data cleaning for clinical trials, resolve discrepancies, and manage auto and manual queries and data clarification forms to ensure compliant, accurate datasets.
Module 7 Medical Coding clinlearn6:13
Learn how medical coding supports adverse events, concomitant medications, and medical history by applying MedDRA and the WHO drug dictionary, with automated and manual coding workflows in CDMs.
Module 8 Data Cleaning External Data clinlearn5:37
Reconcile external data through data cleaning to ensure consistency, and compare central lab versus local lab data workflows while managing acquisition forms, edc, iwrs, and cdm queries.
Module 9 SAE Reconciliation clinlearn2:59
Learn how to reconcile SAE data points between safety and clinical databases, identify mismatches, and document corrections to ensure accurate CDM data.
Module 10 Database Lock clinlearn4:34
Master the final database lock in clinical data management, ensuring closed data, verified source data, and approved medical coding and reconciliation. Distinguish partial versus complete database lock for regulatory submission.

Requirements

Life Science, Nursing, Pharmacy or similar graduates

Description

The course would give you a detail of all crucial topics related to Clinical Data Management and it’s basics. The 10 modules would lead to systematically to the depth of each specific subject. At the end you will come out with filled with knowledge about Clinical Data Management which would be extremely useful when you start working in CRO or Pharma companies as clinical research professional.

1)Introduction to CDM

2)Clinical Trial Phases in Clinical Data Management

3)Case Report Form

4)Clinical Data Management System

5)Data Entry

6)Data Cleaning

7)Medical Coding

8)Data Cleaning External Data

9)SAE Reconciliation

10)Database Lock

Who this course is for:

Life Science, Nursing, Pharmacy or similar graduates