PCR 002 Module

PCR 002 Module

PCR-002: Study Start-Up, Data Management, Investigational Product (IP) & Safety Reporting Module

Participants will gain knowledge and principles for Study Start-Up, Research Data Management, and the types of essential documents to be maintained in the investigator file. Participants will also gain a better understanding about the safety reporting requirements for both investigator-initiated and sponsored trials, and an appreciation of the myriad of regulations governing investigational product management in clinical trials. Participants will learn about handling investigational products in accordance with Good Clinical Practice principles.

Agenda

The online module encompasses the following topics:

Core Modules

  • Study Start-Up Overview

  • Research Data Management

  • Essential Documents and Proper Documentation

Supplementary Modules & Readings

  • Investigational Product (IP) Management and Documentation

  • Introduction to Safety Reporting in Research

  • Reportable Safety Events to NHG DSRB

Learning Objectives

Core Modules

  • Gain general understanding of the key steps required for a research study to start-up successfully

  • Learn about the important tasks involved in starting a study (e.g., Study Planning, Resources, Compliance, Training).

  • Learn about the best practices for launching a research study successfully

  • Understanding the overview of post approval reporting requirements

  • Understand the definition of Research Data and Research Data Management

  • Understand the overview of Research Data Management (e.g., Data management plan, data collection & document, data storage, retention, sharing, protection & security)

Supplementary Modules & Readings

  • Maintain the essential documents and investigator file for a research study.

  • Perform proper documentation in a research study.

  • Understand and apply the responsibilities in AE management and safety reporting requirements.

  • Apply the regulatory requirements to investigational product management at the clinical trial site.

  • Ensure proper handling of IP at the study site.

  • Maintain proper documentation related to handling of investigational products in clinical trials.

Schedule

This Online Course Module is available on a continuous basis (via E-Learning).

Registration

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