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Thursday, March 21, 2019
Home » GCP: Clinical Trial Monitoring: Site Evaluation and Set-up

GCP: Clinical Trial Monitoring: Site Evaluation and Set-up (GCP04)

Certification Training
Duration: 2 hours, Online (the average time to complete the training program, including final assessments).
Credits Hours: 2
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

Contact the BioPharma Institute for more information.

BioPharma Institute LogoTraining Program: GCP: Clinical Trial Monitoring: Site Evaluation and Set-up
Training Provided By: BioPharma Institute

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment. BioPharma Institute ReviewsThe 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 online course provides an understanding of the training requirements for clinical research associates (CRAs), including familiarization 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.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

The GCP: Clinical Trial Monitoring: Site Evaluation and Set-up course is found in the following professional certification program(s):

Professional Designation in Clinical Trials Monitoring: Good Clinical Practice (GCP) refers to a set of international ethical and scientific quality standards for designing, conducting, recording, and reporting trials that involve human subjects. GCP compliance ensu ... Learn more

Professional Designation in Clinical Trials Management: For Clinical Research Associates, Project Managers, and Clinical Managers. ... Learn more

Professional Designation in Good Clinical Practice: For Clinical Research Associates, Project Managers, and Clinical Managers. ... Learn more



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.


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.

Online Training Program Benefits:

  • Immediate access to training: Instructions, username, password and receipt of payment emailed instantly upon online enrollment
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter
  • Self-paced courses: 24/7 access to individual courses for 90 days; and 180 days for professional certification programs
  • Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
  • Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
  • Verification of training: Certificates can be verified online, and electronic badges are issued for all Professional Certification programs
  • Corporate reimbursements: Employers may pay for or reimburse employees for training. Purchase orders (POs) for both individual and group training are accepted
  • Corporate LMS solutions: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
  • Secure and safe access: Website and LMS offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
  • Career advancement: Professional certifications may be helpful for those seeking new careers or transitioning to different positions within their organization

For more information on the BioPharma Institute's training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370, or email

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