GCP Essentials

Essential Documents in Clinical Trials

Learn about the critical documents required throughout the clinical trial lifecycle and their purpose.

7 min read•about 4 hours ago

9

Source Documentation and Data Integrity

Understand the principles of source documentation and data integrity that form the foundation of credible clinical trial data.

9 min read•about 3 hours ago

11

Clinical Trial Monitoring Visits

Understand the purpose and procedures of monitoring visits and how to prepare effectively for monitor interactions.

9 min read•about 7 hours ago

18

Introduction to Good Clinical Practice (GCP)

Learn the fundamental principles of GCP and why these guidelines are essential for ethical clinical research.

8 min read•31 minutes ago

255.0

The Informed Consent Process in Clinical Trials

Master the principles and practices of obtaining ethically valid informed consent in clinical research.

8 min read•about 7 hours ago

16

Roles and Responsibilities in Clinical Trials

Explore the distinct roles of sponsors, investigators, ethics committees, and regulators in clinical research.

8 min read•about 3 hours ago

22

Adverse Event Reporting and Safety in Clinical Trials

Master the critical requirements for identifying, documenting, and reporting adverse events to ensure participant safety.

10 min read•about 4 hours ago

27

Quality Management in Clinical Trials

Implement effective quality management systems using risk-based approaches and proactive quality assurance strategies.

9 min read•about 9 hours ago

235.0

ICH E6(R3) Overview and Key Changes

Understand the structure and key changes in ICH E6(R3) and how they impact clinical trial conduct.

8 min read•26 minutes ago

42

Protocol Development and Amendments

Learn the essential elements of protocol development and best practices for managing amendments during trial conduct.

9 min read•about 1 hour ago

15

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GCP Essentials

Core Good Clinical Practice knowledge including ICH E6(R3) guidelines, fundamental principles, and essential terminology

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Showing 10 of 10 resources

Essential Documents in Clinical Trials

Learn about the critical documents required throughout the clinical trial lifecycle and their purpose.

7 min read•about 4 hours ago

9

Source Documentation and Data Integrity

Understand the principles of source documentation and data integrity that form the foundation of credible clinical trial data.

9 min read•about 3 hours ago

11

Clinical Trial Monitoring Visits

Understand the purpose and procedures of monitoring visits and how to prepare effectively for monitor interactions.

9 min read•about 7 hours ago

18

Introduction to Good Clinical Practice (GCP)

Learn the fundamental principles of GCP and why these guidelines are essential for ethical clinical research.

8 min read•31 minutes ago

255.0

The Informed Consent Process in Clinical Trials

Master the principles and practices of obtaining ethically valid informed consent in clinical research.

8 min read•about 7 hours ago

16

Roles and Responsibilities in Clinical Trials

Explore the distinct roles of sponsors, investigators, ethics committees, and regulators in clinical research.

8 min read•about 3 hours ago

22

Adverse Event Reporting and Safety in Clinical Trials

Master the critical requirements for identifying, documenting, and reporting adverse events to ensure participant safety.

10 min read•about 4 hours ago

27

Quality Management in Clinical Trials

Implement effective quality management systems using risk-based approaches and proactive quality assurance strategies.

9 min read•about 9 hours ago

235.0

ICH E6(R3) Overview and Key Changes

Understand the structure and key changes in ICH E6(R3) and how they impact clinical trial conduct.

8 min read•26 minutes ago

42

Protocol Development and Amendments

Learn the essential elements of protocol development and best practices for managing amendments during trial conduct.