GCP: An Introduction to Clinical Trial Preparation and Design - Product Image

GCP: An Introduction to Clinical Trial Preparation and Design

  • ID: 2861559
  • Training
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Worldwide expenditure on R&D by the pharmaceutical industry is continually increasing. Most of the financial investment in the production of a new drug is allocated to clinical trials.

Given the financial risk involved, it is crucially important that clinical trials be designed and set up efficiently to obtain adequate and accurate data in compliance with regulatory requirements.

This module aims to provide you with effective strategies for the preparation and conduct of a clinical trial, while adhering to regulatory safety standards. Management of data for submission is also covered.

OBJECTIVE

Describe the evaluation and qualification process at an investigational site.

Identify the study documentation required prior to commencing work on a clinical trial.

Describe what is required of a study site to conduct a clinical trial successfully.

Outline the procedures to be conducted prior to the initiation of a study site.

Describe the measures taken during site evaluation, set-up and initiation to ensure that the conduct of clinical trials complies with the protocol.

Describe the initiation process at an investigational site.
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Overview
This session briefly describes the relevant legal
documents and guidelines relating to clinical trial design.

Clinical trials in drug development
The crucial role of clinical trials in the drug development cycle is examined. Regulatory requirements and financial pressures, and their interaction with trial design, are discussed.

Protocol design
This session provides an overview of clinical trial protocols. Opportunities to improve a clinical trial protocol for regulatory approval are also discussed.

Clinical trial preparation
This session provides an overview of the role of the sponsor in supporting and improving quality in the conduct of clinical trials.

Endpoints
This session focuses on clinical trial endpoints. The purpose of endpoints and the types are discussed in this part.

Statistical elements
This session covers the role of statistics in clinical trial design and analysis, as acknowledged in the International Conference on Harmonisation (ICH) guideline for Good Clinical Practice (GCP).

Study design
This session provides an overview of the main types of study design.

Data capture and management
This session describes the purpose of data capture and explores efficiencies in data management as part of the evolving regulatory landscape.

Assessment
Multiple-choice mastery assessment.
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