Description

Clinical Operations Courses
Part of a STAR Programme

Do you want to refresh and improve your CRA skills?  Do you need some inspiration to boost your clinical trial monitoring techniques and approach? This blended learning course provides for experienced monitors the knowledge and advanced skills to deal with more complex clinical trials and site management issues. This face to face training, supported by eLearning provides best outcome allowing you to learn at your own pace.

Through an interactive approach, in this blended learning course you receive a concise update of the current European clinical trial legislation and you will learn more about clinical trials in developing countries. The critical milestones of clinical trials, contingency plans, dealing with non-compliances, risk-based monitoring, your relationship with the investigator and coaching junior CRAs are the main topics of this course.

The Face-to-face session will implement the eLearning material in practice: how to upgrade monitoring methods and skills, how to select the right investigators, how to boost subject recruitment, how to detect and correct informed consent issues, how to solve site management matters and how to deal with non-compliance. You gain insights in developing monitoring plans, tracking tools, accurate monitoring visit reporting and corrective and preventive actions. You will be reviewing cases from real life situations during workshops.

Lively discussion and action planning involving real-life cases in the classroom are one of the main learning areas. Here you will benefit not only from the trainers but also learn from each other’s experiences.

The complementary eLearning course includes interactive quizzes and exercises for self-assessment to provide a better understanding of each part of the course. After attending the classroom training course, you will be able to test your comprehension with a final overall grading assessment.

All ECCRT eLearning courses include a touchpoint with the trainer to discuss open questions from any student. Continuous interactivity with the trainer and fellow students is also encouraged through the ECCRT Virtual Campus Discussion Forum.

Course time
Classrooms: 09h00 - 17h00 / eLearning: Course Credits: 6 hours
Who should attend

Clinical Research Associates (CRAs) with minimum of 2 years of experience, who want to boost their CRA skills and to set new objectives in their career and/or experienced people working in clinical data processing, biostatistics, regulatory affairs, etc.
If you have a particular interest in clinical trials with medical devices, you may prefer to attend our “Running Medical Devices Trials” course.

Programme highlights
  • Importance of international research – the role of the ICH process
  • Update on overview of the current European legislative requirements, including guidance on substantial trial modifications
  • Questions and Answers on monitoring plan
  • Selection of the right investigator
  • The informed consent: process verification
  • Improving subject recruitment and tips for site staff to enhance subject retention
  • Upgrading monitoring tasks: prioritising monitoring activities, accurate monitoring reporting, efficient tracking, dealing with non-compliances
  • Coaching junior CRAs.
Learning Objectives
  • Be up-to-date on current European legislative rules
  • Manage investigational sites effectively from screening to database lock
  • Take the right actions to resolve site issues, ascertain appropriate corrective and preventive actions
  • Expand your knowledge and improve your monitoring skills

 

Competencies  

This course covers competencies that are part of the ECCRT Competency Framework  

  • Scientific Concepts & Research Design (0)
  • Ethical & Participants Safety Considerations (5)
  • Investigational Product Development and Regulation (4)
  • Clinical Studies Operations (GCPs or ISO 14155) (7)
  • Study and Site Management (5)
  • Data Management and Informatics (5)
  • Leadership and Professionalism (3)
  • Communication (3)
  • Teamwork (0)
  • Business acumen (0)

Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained  

Book a course

Date Lang Location
 
Proceeding your application may take up to 24 working hours. In case of question, contact campus@eccrt.com.

Booking is desired 1 week before F2F session in order to allow the participant to go through pre-read materials.
1 100,00 € excl. VAT (if applicable)

Testimonials

Nadine Severins
January 2018
Company
CTCM

It is an elaborate course which covers many aspects of monitoring. It was nice that we were given the opportunity for discussion and asking questions.