GCP: Clinical Trial Monitoring: Study Monitoring, Documentation and Closure
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Download 2024 UPDATE:
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
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Free Trial CoursesOutline: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 summarizes 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. Summary: Key point summary for all topics covered in This online course. Ideal for review, a refresher or consolidation of learning points. | Objectives:Students completing this course should be able to: 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. Summarize the role of the monitor in preparation for a site audit. Identify the responsibilities of the CRA in identifying and reporting scientific misconduct. | |
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