11/21/2019

What is ICH and why is it important? The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) accomplishes its mission to promote public health through global harmonization by creating technical Guidelines that will be implemented by regulatory authorities in Member States. ICH E2A is one of the Guidelines related to clinical trials. Common standards among regions means that data from clinical trials in one region can be used in another, which reduces duplication of efforts and improves efficiency.

What is ICH E2A? ICH E2A provides guidance on how to handle expedited safety reporting and includes important definitions and standards. Following harmonized standards and procedures for safety reporting on investigational products ensures Good Clinical Practice (GCP).

What parts of the Guideline are applicable for investigators and study site personnel? The Clinical Pathways Clinical Safety Data Management: Definitions and Standards for Expedited Reporting interactive eLearning course covers the international Guideline ICH E2A. Content includes a review of ICH, definitions and terminology related to the clinical safety experience, standards for expedited reporting, reporting time frames, procedures for reporting, managing blinded therapy cases, informing Ethics Committees and investigators, and Quality Management Systems. Understanding what is important to include in a clinical safety report can support efforts to follow GCP.

The eLearning course offers:

Interactive content
Knowledge Checks
Post Assessment
Scenarios to apply your knowledge
Certificate of Completion

To sample an interactive demo or to purchase the full course, visit our store here.

- The Clinical Pathways Team

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