Adverse Event CONTENT Package

This comprehensive package includes a content reference article, SOP, powerpoint presentation, and trainer instructional notes. Includes:

➢1. Drug Safety and Adverse Events for Clinical Trials: An Introduction (Content Reference Article)

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➢2. Serious Adverse Event Processing, Reporting, and Safety Review for Clinical Trials SOP

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➢3. Adverse Event (PDF PowerPoint Training Presentation)

➢4. Adverse Event (Trainer Instructional Notes)

1. Drug Safety and Adverse Events for Clinical Trials: An Introduction (Content Reference Article)

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This 11 page article takes a life cycle approach to this subject matter content by reviewing how to define adverse events and serious adverse events, characteristics, types of adverse events, defining roles and responsibilities in managing adverse events, through to FDA reporting requirements for serious adverse events.

➢Defining an Adverse Event

-The basics – 21 CFR 312.32

-Characteristics of an adverse event

-Eliminating apparent adverse events

➢Defining Roles and Responsibilities in the Management of Adverse Events

-Types of adverse events

-Subject welfare and rights

-Institutional review boards

-Principal investigation sites

-Monitoring subjects

-Assessment of causality

-Assessment of outcome

-Follow-up of adverse events and serious adverse events

-Prompt reporting of serious adverse events to the sponsor

➢FDA Reporting Requirements for Serious Adverse Events

-CFR regulations

-Dear investigator letters

➢FDA Top Five GCP Inspectional Observations (Chart)

2. Serious Adverse Event Processing, Reporting, and Safety Review for Clinical Trials SOP

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This nine (9) page SOP defines the process, review and evaluation requirements for adverse event information and requirements to maintain compliance with regulatory reporting requirements.

➢Provides definitions for 20 key terms.

➢The procedure section of this SOP is divided into the following sections below:

➢Source of SAE information

➢Forwarding of SAE information from clinical trial sites

➢Acknowledgment and processing of SAE information

➢Medical review

➢Follow-up requests for SAE information

➢Regulatory reporting of clinical trial SAEs

➢Attachment included: SAE Clinical Trials Details Reporting Form

3. & 4. Adverse Event (PDF PowerPoint Training Presentation & Trainer Instructional Notes)

12 slide PDF PowerPoint Training Presentation based on the subject matter presented in the reference content article above. This PDF ready made presentation provides “core” subject matter content, and allows you to customize specific information within your presentation. Trainer instructional notes, which contain 40+ discussion points related to the PowerPoint training presentation, are also included. Trainer instructional notes are designed to help focus your presentation on key points, engage attendees and encourage their participation in your training.

Adverse Event CONTENT Package is only $109.00...