CRA of CTCVN carries out all activities of site coordination and site monitoring, including:
1. Quality control before conducting the study to check the readiness of the study site
2. Site initial monitoring– SIV monitoring
3. Interim monitoring – IM
4. Site close out monitoring – SCV
5. Perform compliance monitoring with ICH-GCP, comply with all applicable legal regulations and follow the study protocol.
CTCVN ensures compliance with research sites through ongoing review and evaluation activities as follows:
1. Certification and experience of the investigator team
2. Facilities, storage, equipment and investigator team
3. Accessibility and eligibility of research subjects
4. Review of legal documents
5. Accuracy and timely completion of CRF and source documents
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