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

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Program/Course ID: GCP04 Enrollment Period: 12 months. Average Learning Time: ~. Additional Resources: Supplemental materials & activities. Credit Hours: 3 credits. Method of Training: Online, asynchronous, self-paced eLearning. Accessibility: 24/7 access to all program materials. Demonstration: Four (4) free trial courses are available. Group/Employee Training: Click here to request a quote or invoice. Final Assessment: Multiple choice; unlimited attempts. Certificate: Encrypted PDF with QR validation code.

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Saturday, May 16, 2026 UPDATE:
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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Outline: 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 Harmonization (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. 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: 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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Comments: For quotes or invoices please provide the titles of the course(s) and number of students.	GCP: Clinical Trial Monitoring: Site Evaluation and Set-up