Site visits | When | Key activities |
---|---|---|
Monitoring visit during enrolment | One visit, 4 weeks since the start of enrolment. | - Inspection of all ICH GCP certificates in place - Verification of informed consent forms - Eligibility check - eCRF completion - Equipment, consumables, study material - Review laboratory sample management |
Monitoring visit follow-up—first | One visit 6 months since the start of enrolment. | - Specimen collection procedure - Eligibility check - eCRF completion - Eligibility of source documents - Source data verification - Review AE/SAE reporting |
Monitoring visit follow-up—second | One visit 12 months since the start of enrolment. | - Specimen collection procedure - Eligibility check - eCRF completion - Eligibility of source documents - Source data verification - Review AE/SAE reporting |
Close-up visit monitoring | One visit 18 months since the start of enrolment (end of study) | - Last query resolution - Storage and archiving of documentation - Review, update, and finalization of IF |