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