PROCESSING DATA IN CLINICAL TRIALS

8 hour course

THE TRAINING COURSE
As we know, collecting, circulating and conserving the multiplicity of information regarding health and, in some cases, the sex lives of people involved in clinical trials present various critical aspects to do with the protection of personal data and, therefore, higher precautions aimed at preventing specific risks for the interested parties need to be adopted.

OBJECTIVES
The objective of the course is to focus on the crucial aspects that affect privacy in clinical trials and the scope that they will have when the European regulation comes into force. Students will acquire the skills needed for a 360° understanding of the elements in play in stratified management, data processing and the correct assessment of risk relative to the processing.

TARGET AUDIENCE

  • Internal Auditors
  • Data Protection Officers
  • Data Processors of personal data

MINIMUM REQUIREMENTS

  • Basic knowledge of Italian Legislative Decree 196/2003 and Italian Legislative Decree 219/2006
  • European Regulation EU GDPR 2016/679

REGULATIONS OF REFERENCE

  • European Regulation EU GDPR 2016/679
  • Italian Legislative Decree 196/2003
  • Italian Legislative Decree 219/2006

TEACHING
The course is given by teachers with specific experience in management systems, processes and procedures related to processing data held in corporate databases in compliance with the statutory requirements of existing Data Protection regulations

CERTIFICATE
Valid as a refresher course to maintain certification as an Auditor, SGCMF©10002:2013 and ISDP©10003:2015 – 8 course credits

THE PROGRAMME

9:00-18:00

• Definition of: Sponsor, Trial Centre, CRO
• The nature of the data processed
• Informed health consent and patient privacy information
• Exercising rights
• Correct management when transferring data overseas
• Data conservation and security given by CROs
• New EU regulation 2016/679 – implications for clinical studies