Ich e2a clinical safety data management: definitions and standards for expedited reporting

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Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (ICH E2A)
LEARNING OBJECTIVES
ONBOARDING OR ANNUAL REVIEW CURRICULUM
E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting March 1995
Submit Comments
What are the Standards for expedited reporting?
What is E2A guideline?
What does expedited reporting mean?
Which guidelines we use for clinical safety data management?

Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (ICH E2A)

$199.00

INTERACTIVE DEMO AVAILABLE BELOW

This course covers the international Guideline ICH E2A, which relates to Clinical Safety Data Management. Sections include a review of ICH and an introduction to ICH E2A; Definitions and Terminology related to the clinical safety experience; standards for expedited reporting; reporting time frame, the procedures for reporting, managing blinded therapy cases, miscellaneous issues, and informing Ethics Committees and Investigators; and Quality Management Systems.

This course can be used alone or as part of the full curriculum; for more information refer to the additional information below.

Course Length: 45 minutes

INCLUDES:

Unlimited access to the content for 45 days from your initial day of purchase.
Certificate of completion
Case Studies
Post-Assessment
Knowledge Checks

LEARNING OBJECTIVES

Apply critical thinking techniques for effective implementation of the ICH E2A guidelines.
Reflect on how the ICH E2A global guideline affects your role in clinical research.
Discuss challenges and opportunities in implementing the ICH E2A guideline.

AUDIENCE

All clinical research personnel

ONBOARDING OR ANNUAL REVIEW CURRICULUM

This course can be used alone or as part of the full curriculum, including:

GCP Training: ICH E6(R2) - Available HERE
Good Documentation Practices and ALCOA-C - Available HERE
Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (ICH E2A) - Available HERE
Structure and Content of Clinical Study Reports (ICH E3) - Available HERE
Overview of 21 CFR 312 Investigational New Drug Application (IND) and 21 CFR 314 Application for FDA Approval to Market a New Drug (NDA) - Available HERE
Overview of 21 CFR Part 50 Human Subject Protection and 21 CFR Part 56 IRB/IEC - Available HERE
Overview of 21 CFR Part 11 Electronic Data / Signatures & 21 CFR Part 54 Financial Disclosure - HERE

The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

Internet:

https://www.gmp-compliance.org/files/guidemgr/E2A_Guideline.pdf

Origin/Publisher:

ICH

Content:

This document gives standard definitions and terminology for key aspects of clinical safety reporting. It also gives guidance on mechanisms for handling expedited (rapid) reporting of adverse drug reactions in the investigational phase of drug development.

GUIDANCE DOCUMENT

E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting March 1995

Final

Docket Number:FDA-1993-D-0128Issued by:

Guidance Issuing Office

Center for Drug Evaluation and Research

It is important to harmonize the way to gather and, if necessary, to take action on important clinical safety information arising during clinical development.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-1993-D-0128.

This document aims to develop standard definitions and terminology for key aspects of clinical safety reporting. I also provides guidance on the appropriate mechanism for handling expedited (rapid) reporting, in the investigational (i.e. pre-approval) phase.

Keywords: Clinical development, clinical safety reporting, expedited reports, adverse drug reaction (ADR)

What are the Standards for expedited reporting?

The minimum information required for expedited reporting purposes is: an identifiable patient, the name of a suspect medicinal product, an identifiable reporting source, and an event or outcome that can be identified as serious and unexpected and for which, in clinical investigation cases, there is a reasonable ...

What is E2A guideline?

What does expedited reporting mean?

The purpose of expedited reporting is to make regulators, investigators, and other appropriate people aware of new, important information on serious reactions.

Which guidelines we use for clinical safety data management?

The Note for Guidance on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (CPMP/ICH/377/95) is an internationally accepted standard for the reporting of important clinical safety information principally arising during clinical development of medicines.