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GXP283 Clinical Data Management

GXP283 Clinical Data Management

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:

GXP283 Clinical Data Management
Dr. Faheem S. Khawaja
Dr. Faheem S. Khawaja (PharmD, MS) is an E-Learning content specialist, working as a Research Manager at Prime Foundation Pakistan, with 5 years of professional experience in healthcare and academia with a research interest in pharmaceutical nanotechnology and drug delivery systems. He is a highly capable and motivated Healthcare professional with superior analytical and problem-solving skills. Faheem possesses extensive knowledge of Pharmaceuticals and their regulatory bodies, database design, and medical informatics.

$144.00 $240

3 days left at this price!

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General info:

Duration :

2

hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

Reviews:

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.

Alex S

-

Chief Operations Officer

$144.00 $240

3 days left at this price!

Buy now
GXP283 Clinical Data Management

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