GCP: Clinical Trial Monitoring: Study Monitoring, Documentation and Closure

  • ID: 2861562
  • Training
  • Leopink
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Once a trial is initiated, the crucial role of the clinical research associate (CRA) is to monitor the conduct of the trial and the integrity of the data recorded. This module introduces areas such as monitoring of case report forms (CRFs), source document verification and the review and maintenance of essential documents. The responsibilities and procedures associated with monitoring processes and close-out visits are also explained.

OBJECTIVE

Outline the monitoring activities conducted on a site visit.

Identify the requirements for accurate and consistent CRF completion by site staff.

Define the CRA's responsibilities for the monitoring and review of CRFs.

Define source documents and the procedures for source document verification.

Identify the essential documents which must be available prior to the commencement of a clinical trial at each investigational site, during the conduct of a clinical trial, and after completion or termination of a clinical trial to comply with ICH Good Clinical Practice (GCP) guidelines.

Describe the procedures to be conducted to close a trial at each investigational site, when the requirements of the protocol have been fulfilled, or if continuation of the trial is considered inappropriate.

Explain the importance of sponsor site audits.
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Overview
This session briefly describes the legislative guidelines used to conduct clinical trials.

Monitoring visit
This session outlines the preparation, conduct and follow-up of a routine monitoring visit.

CRF review
Case Report Forms are crucial in conducting a successful clinical trial. This session discusses the monitoring and review of CRFs.

Source document verification
Inadequate understanding of the process involved in source document verification results in the procedure being ineffective. This session explains the importance of source document verification in clinical trials.

Essential documents: Collection and review
The ICH GCP guideline identifies a minimum list of essential documents that are required throughout a trial, including specific details of where each document should be filed during the study, and their purpose. This session summarises these documents.
The contents of the Trial Master File and Investigator Site File are also described.

Close-out visit
This session outlines the preparation, conduct and follow-up of a close-out visit.

Sponsor site audits
This session will focus on sponsor site audits. The purpose of sponsor audits will be described, as well as the role of the CRA and common audit findings.

Fraud and scientific misconduct
CRAs are sometimes faced with serious situations, namely errors, misconduct and fraud. This session will focus primarily on the CRA's role in these unfortunate events.

Assessment
Multiple-choice mastery assessment.
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