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
