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

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

Certification Training
 
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Method of Training: Online / Self-paced eLearning.
Credits: 1.5 CPD Credits.
Duration: ~1.5 hour(s).
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: Clinical Trials Management and Monitoring.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $175.00

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

Biopharma Institute LogoTraining Program: GCP: Clinical Trial Monitoring: Site Evaluation and Set-up
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute Reviews

The sponsor of a clinical trial needs to reach agreement with clinical investigators to conduct the trial. The suitability of investigators and their institutional sites, typically hospitals, has to be evaluated, and the trial has to be set up at each site. This module describes the processes involved, focusing particularly on the role of a Clinical Research Associate (CRA) employed or contracted by the sponsor to monitor the trial.

The purpose of investigational site evaluation and set-up is to ensure that the site has access to the required patient population, has appropriately qualified, trained and committed staff with adequate time and facilities, and that it is fully prepared for the safe and successful conduct of the clinical trial. In this module we set out the criteria, procedures and documentation for evaluating a site and setting up a trial there.

This online training program includes immediate access after enrollment. Username, password, and instructions are emailed to the student following the enrollment into the program. 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 certification of training achieved and a certificate is immediately made available to the student.

Benefits of Getting Certified at Biopharma Institute

Throughout many of our courses, students will engage in active learning using interactive eLearning modules developed to promote the learning of key knowledge and information. For companies seeking a method to train employees, economically, without having to set aside an entire day for them to attend a live course, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, interactive, self-paced learning experience which fits in with most types of learners. We cater to both small-scale and large-scale training requests, customizing your employee's education.


Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.


COURSE OUTLINE:


Module overview
Sets out the module's scope, objectives and notes on terminology.

Investigational site qualification
Each candidate investigational site needs to be assessed for its suitability for the trial. A CRA and/or other representatives of the sponsor will typically visit the site to discuss the trial with the potential investigator and learn about the resources that can be deployed there. In this session we describe the objectives of the visit, preparation for it, and its conduct. We set out factors that should be assessed and give examples of the sorts of issues that may arise.

Preparation for trial initiation
When one or more investigational sites are approved by the sponsor, various activities are carried out concurrently in preparation for the start of a trial. In this short session we outline the tasks leading up to site initiation.

Trial initiation at an investigational site
An initiation visit is made to ensure that the participating site is ready for the conduct of the clinical trial and that the relevant personnel have a clear and accurate understanding of how the study is to be conducted. The CRA will review the clinical protocol and procedures with the team, check that all study materials are in place and that facilities and equipment are ready, ensure that the investigator's trial master file is in order, and confirm the monitoring plan and provisions for audit and inspection. We describe the actions that should be carried out.

Assessment
Multiple-choice mastery assessment.

COURSE OBJECTIVES:


Who will benefit from this module?
The module is primarily aimed at those involved in clinical research and development, in particular the monitoring of clinical trials at the investigational site, and those who require an understanding of what this entails. It and its companion module (Course ID: GCP002) provide a comprehensive introduction to the field for new CRAs/monitors, or additional training and professional development for those already working in the field. Clinical trial administrators and study coordinators who require more training in order to enter the wider CRA employment market will also benefit from the module.

Learning objectives
  • State the objectives of an investigational site qualification visit and describe how to carry one out.
  • Describe how to prepare for initiation of a clinical trial at an investigational site.
  • State the objectives of a trial initiation visit and describe how to carry one out.

The GCP: Clinical Trial Monitoring: Site Evaluation and Set-up Course is Included in the Following Professional Certification Programs:


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 (US & EU) Professional Certification Program: This online professional certification program is for regulatory affairs personnel, clinical managers, project managers, investigators, and clinical research associates. It is also available to those interested ... Learn more

Online Training: The Benefits of eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are 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 for professional certification programs for 180 days.
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements.
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