Clinical Monitoring

A- Pre-study Phase Activities

  • Investigators selection
  • Study site selection
  • Contract staff: CRAs, Data Managers, etc.
  • Start-up meetings (First investigator meeting)
  • Ethics Committee (EC) submission till approval obtaining
  • Submission of files to Health Authority
  • Preparing Trial Master Files (TMF)
  • Preparing Investigators Study Files (ISF)
  • Drug importation services
  • Project Team Training: ICH-GCP & specific protocol training for Investigators, co-investigators and CRAs

B- Site Initiation Activities

  • Training of study team
  • Essential pre-study documents submission (investigator brochure, insurance certificate, blank forms, protocol amendments, etc.)
  • Study drug availability and storage
  • Prepare TMF and ISF

C- First-Patient In visit (FPI)                            

  • Protocol compliance and eligibility criteria
  • GCP compliance (written informed consent, etc.)
  • 100% CRF/SDV verification
  • Drug: (administration, accountability, storage)
  • Adverse Events monitoring

D- Follow up Monitoring Visits                      

  • Protocol compliance and eligibility criteria
  • GCP compliance (written informed consent, etc.)
  • CRF/SDV verification
  • Drug: (administration, accountability, storage)
  • Adverse events (AE, SAEs) monitoring
  • ISF inspection and completion

E- Close-Out Visits

  • GCP compliance
  • CRF/SDV verification
  • Certificate of drug destruction
  • ISF inspection, completion & archiving at study site
  • TMF completion & archiving