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GCP: Clinical Trial Monitoring: Site Evaluation and Set-up (GCP004)

Certification Training Duration: 2 hours (the average time to complete the training program, including final assessments).
Credits Hours: 2
CPD Accredited TrainingAccreditation: This training course offers CPD accreditation from the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians.
CPD Credits: 1.5
Demonstration: Demo an online course.

Certificate: View sample certificate.

PRICE: USD $195.00 LogoTraining Program: GCP: Clinical Trial Monitoring: Site Evaluation and Set-up
Training Provided By:

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

Site evaluation and the set-up’s purpose is to ensure that the site is fully prepared for the conduct of the clinical trial, facilitates to conduct the study, has adequate time and appropriately qualified staff, and has access to the required patient population. This course will furnish the student with a better concept of required training for CRAs (Clinical Research Associates) and will include methods through which the student will become more familiar with study documentation. Described in detail, with particular attention paid to the site qualification visit, will be the procedures needed before an investigational site can be initiated. The procedures and responsibilities associated with preparation and conducting of initiation visits will also be discussed at length.

The entire program must be viewed by students in order to pass. An online, multiple-choice final assessment score of 80% or better is required. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade. Once all course requirements have been satisfied, a certificate of completion is immediately available.

Benefits of Getting Certified at

By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the provides professionally designed online courses which are effective at training, and assist those interested with advancing their careers. The also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service. The offers proven methods that can help you, your company, and your colleagues to further your education or simply refresh your existing knowledge. Many of our courses bring to light important changes which have recently taken effect and been applied in various areas of the healthcare, pharmaceutical, and clinical research industries.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 111-1111 or send us an email at for more information.

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.

Online Training Programs Include:

  • Immediate access to training: Instructions, password, and username are emailed following order
  • 90 days of 24/7 access to individual training programs / 180 days for Professional Certification Program
  • Programs include voice-overs, easy navigation, progress checks, and high-quality animations
  • Course notes (in PDF) and/or references available with select training programs
  • Online final assessment with multiple-choice questions can be taken an unlimited number of times, until passing grade is achieved
  • A Certificate of Completion is immediately available once course requirements have been satisfied

The GCP: Clinical Trial Monitoring: Site Evaluation and Set-up Course is Found in the Following Professional Certification Program(s):

Clinical Trials Monitoring Professional Certification Program: GCP, or Good Clinical Practice, refers to a set of scientific and ethical quality standards for reporting, recording, conducting, and designing trials that involve human subjects. GCP compliance ensures the wel … Learn more

Clinical Trials Management Professional Certification Program: This professional certification program is designed for clinical managers, project managers, and clinical research associates and coordinators, or those with desire to grow their career into these positions. Co … Learn more

Good Clinical Practice Professional Certification Program: This online professional certification program is for clinical managers, project managers, investigators, and clinical research associates and coordinators, or those with the desire to grow their career into th … 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.


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