GCP: Clinical Trial Monitoring: Site Evaluation and Set-up

  • ID: 2861561
  • Training
  • Leopink
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The purpose of site evaluation and set-up is to ensure that the site has access to the required patient population, has appropriately qualified staff, adequate time and facilities to conduct the study and to ensure the site is fully prepared for the conduct of the clinical trial.

This module provides an understanding of the training requirements for clinical research associates (CRAs), including familiarisation with study documentation. The procedures necessary prior to initiation of an investigational site, particularly the site qualification visit, are described in detail. The responsibilities and procedures associated with preparing for and conducting initiation visits are also covered in detail.

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 legislative guidelines that apply to the conduct of clinical trials.

CRA training
This session outlines the training requirements for site monitoring according to International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines. The study documentation with which a CRA should be familiar prior to commencing work on a clinical trial is also discussed.

Site qualification visit
This session outlines the preparation, conduct and follow-up of a site qualification visit.

Groundwork
This short session provides an overview of the site related activities which will occur between the site qualification and initiation visit. Although a CRA might not be actively involved, groundwork activities are integral to successful site initiation.

Initiation visit
This session outlines the preparation, conduct and follow-up of an initiation visit.

Assessment
Twenty question multiple choice mastery assessment.
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