Training "Beyond the GCP"

One day for monitoring staff to:

• Consolidate the knowledge of the main points of French regulations, focusing on French Good Clinical Practices (GCP)
• Develop the critical mind required to monitoring staff and promote their judgment in solving daily issues
• Set up a thinking methodology regarding issues encountered

Teaching methods

• For each topic: succession of presentations, quizzes, and simulation exercises or case studies
• Presentations are supported by main audits and inspections findings

Program and topics addressed

This training occurs twice a year. The topics addressed on day 1 are different from those of day 2:

• Introduction :
  • brief reminders on Quality
• Day 1:
  • Selection of Investigational centers (criteria, means, rationales, etc.)
  • Collection of patient consent (specific situations, protected populations, medical record content, etc.)
  • Documentation and source data / verification with Case Report Forms
  • Investigational Medicinal Product (CRA responsibilities, accountability, relabeling, etc.)
• Day 2:
  • Investigator's documentation (Investigator's File objectives, documents' aim, etc.)
  • Monitoring (responsibilities, priorities, training of the investigational team, clinical trials vigilance)
  • Monitoring reports (purpose, content, writing deadlines, etc.)
  • Audits and Inspections (place and role of the CRA during an on-site audit, preparation, etc.)
  • Quality System (processes, input and output)

Attendees' profile

• Clinical Research Associates (CRAs), Study Nurses, Project Managers

Trainers

• Mrs. Frédérique ALBOUY-NAVARRO (Doctor of Pharmacy)
• Mrs. Catherine MERAT (Doctor of Pharmacy)
• Mrs. Estelle ZERBIB (Doctor of Pharmacy)
• Mrs. Mélanie GENTRIC-GUERIN (Doctor of Pharmacy)

Practical criteria

• Place: Paris area
• Duration: 1 day
• Schedule: 9h30-18h00
• Rate: €800 per attendee (taxes not included), including educational fees, documentation, lunch, and coffee breaks. (€1,400 if the attendee enrolls in both training sessions: Day 1 and Day 2.)

• Register