Clinical Data Management

4.5/5
40
Clinical Data Management

Duration :

2

hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Gain a recognized and traceable certificate after completing the course :ย 

All our certificates are unique, authentic, CPD/CEU accredited, and FDA 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker.

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:

patricia kay
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 worked as Clinical Research Associate at Pfizer, GSK, AstraZeneca and she takes part in many startups boards.

Reviews:

4.5/5
40
USD: United States (US) dollar ($)

$48.00 $60

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Certificate of completion

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