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Clinical Data Management

 4.5/5

40

Duration :

2

hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Successful completion provides learners with a dated, traceable and downloadable certificate for the course :

Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.

Description:

Clinical trials take time and consume a lot of resources, hence, they must be conducted after adequate consideration of the whole process. Structures must be put in place to ensure the consistency of conditions as much as possible since this will greatly reduce errors and make the research findings reliable. This course exposes the basics of clinical data management outlining the goals, tools, and processes involved. If the data obtained from a clinical research exercise is deemed unreliable the purpose is defeated and the resources wasted. You will also learn about the CDISC which is an organization that regulates clinical trial operations to ensure compliance with international standards.

This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

Curriculum:

Lesson 1: Overview of Good Clinical Practice

13 Principles of GCP

Lesson 2: What is Clinical Research and Clinical Trial?

Lesson 3: Types and Phases of Clinical Trials

Lesson 4: Clinical Trial Data Management and Professionals

What is Clinical Trial Management?
What is a Clinical Trial Management System (CTMS)?
How to Compare Clinical Data Management Systems

Lesson 5: What is Clinical Data Management?

Model for Data Management in Clinical Trials
Clinical Research Data Areas of Responsibility

Lesson 6: The Roles and Responsibilities in Clinical Data Management

What is Clinical Trial Data Management (CDM)?
Clinical Data Management Plans

Lesson 7: Clinical Trial Data Validation Plan

Data Management Workflow
Clinical Trial Data Audits

Lesson 8: Quality Management in Clinical Data Management

Regulations, Guidelines, and Standards in Clinical Data Management
Case Report Forms in Data Management
Introduction to Electronic Clinical Trial Management Systems
The Business Need for CTMSs
Basic Structure, Contents, and Functioning of CTMS
Electronic System Requirements
Outputs

Glossary

Quiz

Author:

Dr. Patricia Kay

Dr. Patricia Kay is a results focused senior research management professional with over 20 years experience in the life sciences. She has a significant expertise in clinical development, health program management, strategic planning, stakeholder management, business unit operations and personnel management. Dr. Kay has a broad knowledge of cardiovascular disease, immunology, infectious diseases. She takes part in many startups boards.

Reviews:

 4.5/5

40

Data is a major driving force for research. The team has been introduced to data management and data interpretation. Thanks to Dokeos, we can now communicate in terms of reliable data.

$60

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This course includes:

One-year access

Updated content every month

Certificate of completion

GxP-Training Benefits

Experts : We work with the world's top experts in GMP, GLP, GCP, GDP, regulatory affairs, QA and pharmacovigilance.
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