Description

Clinical Operations Courses

Computer System Validation (CSV) in the past often has been anticipatedas an obscure IT topic. However, the addendum of ICH E6 stresses not only the need for validation, data integrity, and data privacy, but also indicates that this is not only an IT issue anymore: "The responsibilities of the sponsor, investigator and other parties with respect to the use of the computerized systems should be clear, and the users should be provided with training in the use or the systems."

Additionally, new technologies (e.g. cloud computing in its different forms) and increased outsourcing to Software as a Service vendors prove to be challenging to remain in control of the data.

The 2-day course provides an overview of the regulatory requirements, guidance documents, and best practices regarding computer system validation in a GCP environment. It is designed to assist those working in clinical operations to ensure that their data is secure and can be trusted. The course covers not only the typical CSV processes (including GAMP 5) and the responsibilities of the different stakeholders, but also IT security and some basic European data privacy requirements are in scope.

Lectures provide sound knowledge regarding the validation of all kind of computerized systems and devices while interactive workshops & cases will assist participants to apply this knowledge to the needs of their own organizations. We have added a second day to this program, to include more practical sessions on importance of using Software as a Service, devices, and digital signatures especially with regard to archiving and record retention

Course time
Day 1 : 10h00 - 17h00 / Day 2 : 09h00 – 15h00
Who should attend

This training is for Clinical Operation people with no or few experiences with Computer System Validation as:

  • Clinical Trial Leads / Project Managers
  • Data Managers
  • Document Management/ Archivists
  • (Supplier) Quality Assurance
  • Clinical Vendor Management
Programme highlights
  • Background and importance of Computer System Validation (CSV)
  • CSV Processes
  • Roles and Responsibilities when validating and using computerized systems
  • Impact of the ICH E6 addendum to CSV
  • Responsibilities of Clinical operation staff in CSV
  • Security Awareness Training
  • Discussion on the use of “difficult” systems, e.g. clouds, electronic Archive, and eTMF
  • Development of User Requirements and Test Scripts for systems proposed by participants
  • Sharing best practices from an industry and regulators point of view
Learning Objectives
  • Identify cases in which validation is needed
  • Explain the need and content of validation documentation for different systems
  • Learn data flows and to identify areas of risk to the data
  • Identify the most important regulatory and practical considerations in when using computerized systems
  • Become aware that information security is not always only a technical issue
  • Identify the needs and issues regarding electronic record retention
  • Share best practices from an industry as well as regulators point of view

 

Competencies

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

  • Scientific Concepts & Research Design (0)
  • Ethical & Participants Safety Considerations (0)
  • Investigational Product Development and Regulation (0)
  • Clinical Studies Operations (GCPs or ISO 14155) (1)
  • Study and Site Management (2)
  • Data Management and Informatics (0)
  • Leadership and Professionalism (0)
  • Communication (0)
  • 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

No session currently available.
In case of interest, please contact us.
 

Testimonials

Enrico Perspicace
May 2018
Company
Genfit

Before going to this course "CSV" was a dark bow for me. So with this training and also with the expertise of our trainer, I'm able to understand almost every thing when people are talking about computer system validation - The training was very interesting thanks to Marc. With his expertise, he explains us the trick of CSV using several studies cases