Training for Investigational Site Staff

Courses

                                                                                                                                                                      

Introduction to Clinical Research Responsibilities (ICH GCP)                                                                         

Duration: 1 day
Level: Basic

• This course is designed to support any personnel of an investigational site involved and responsible for clinical trial related tasks/duties.
• During the course we will focus on current and concrete site's dispositions and step-by-step review of Clinical Research related procedures in accordance with ICH GCP.

The Course is designed for Investigational sites wishing to train a group of employees at a location of their choice.

 

Human Subject Protection for Investigators I.

Duration: 1 day
Level: Proficiency

• The course is designed for investigators and co-investigators with basic knowledge of Clinical Research and ICH GCP who about to or in process of conducting a clinical trial at their investigational sites.
• During the course we will review GCP, GMP and EU Directives requirements from their practical, 'everyday' perspective in order to support you in finding the most suitable way of fulfilling the clinical research responsibilities in alignment with your routine health care practice.

The Course is designed for Investigational sites wishing to train clinical research investigators, co-investigators or coordinators at a location of their choice.

 

Human Subject Protection for Investigators II.

Duration: 1 day
Level: Advanced

• The advanced level course designed for experienced clinical investigators and co-investigators, potentially beneficial also for study coordinators. During the course combined with workshop we will focus on main topics - safety, quality and compliance in Clinical Research.
• The course will provide you with practical insight into the process flow of clinical trial with its various consequences for investigational sites. You will also learn about the best practices suitable for your sites from the trial's perspective.

The Course is designed for Investigational sites wishing to train a group of employees at a location of their choice.

 

Site Audit Readiness

Duration: 1 day
Level: Advanced

• One-day course designed for investigational site's personnel with an objective to prepare participants and the site for an audit/inspection visit. During the course you will learn more about the audit/inspection purpose, about the process and specific expectations on investigational team as well as hints and tips on how to ensure your site is audit-ready on ongoing basis.
• Based on agreement, a tour around the site may be performed to identify the site specific dispositions and focus areas.

The Course is designed for Investigational sites wishing to train a group of employees at a location of their choice.

 

Workshops

 

GCP Refresher


Duration: 0.5 day
Level: Advanced

 

• Are you experienced Clinical Research professionals or Investigational site teams discovering advanced level of GCP related challenges?
• Maybe it is a good time to refresh your knowledge of GCP in a series of selected exercises and case studies to deeper your sense for GCP solutions and prevent GCP automatisms that are not the most effective ones.
 

The Workshop is designed for organisations and Investigational sites wishing to refresh a group of employees or Investigational site teams in GCP at a location of their choice.
 

GCP Filing
 

Duration: 0.5 day
Level: Proficiency

• GCP filing workshop is ready to unlock the world of properly filed documents by providing the participant with the clear and practical live interaction full of exercises, references to ICH GCP, working with the lists of essential documents. GCP filing will become understandable and easy-to-do task for CR professionals so as for Investigational Site staff thanks to the systematic approach of this workshop.
• Combination with other workshops (e.g. GCP Refresher) is recommended, if aimed for the same group of participants.

The Workshop is designed for organisations wishing to train a group of employees or investigational site staff at a location of their choice.