CRA Mission

• Country and site Feasibility / Pre-study visits
• Training of site staff
• Initiation visits
• Collection of critical documents
• Remote and on-site monitoring
• Handling of therapeutic units and drug accountability
• Handling of SAE
• Close-out visits
• Filing of documents in TMF

Project Management

• Participation in the Investigators selection strategy
• Final selection of sites
• Liaising directly with NCI for synopsis approval, ICF and IM preparation
• Setting-up of Investigator’s meeting
• Handling financial agreements with Hospitals, Investigators, Association or tripartite.
• Review of monitoring report
• Coordination between CRAs and sponsor

QA and site audit preparation

• Site staff and pharmacist training (GCP ICH, FDA regulation, sponsor’s SOPs, protocol)

  

• Resolving all remaining queries in a timely manner

• Filing on a regular basis study documents for the TMF

• SOPs development and implementation

Regulatory Affairs

• Initial submission (Interventional/ observational studies) to EC and CA

• 1st patient notification (For France)

  

• Substantial/non substantial amendments

• End of trial notification

• CSR synopsis notification (1 year after the LPLV)

• Payment of submission fees to CAs

On-site support

• Support investigators on site

• Pre-screening of patients

• eCRF filling

• Support management and traceability of clinical supplies (in case of global dispensation)