Maintenance services include but are not limiTED TO:
Investigator Site File – Setup
Includes a tracking system with reminders, full review, completion of outstanding filing and comprehensive list of outstanding documents.
Investigator Site File – Maintenance
Maintaining tracking system and reminders, completion of filing and comprehensive list of outstanding documents.
Source Data Review
Review completed source documents to ensure compliance to protocol, regulatory and SOP requirements.
Informed Consent Review
Review completed Informed Consent Forms to ensure completion in accordance with ICH GCP requirements.
Quality Event Management
Assist with identification, investigation, CAPA implementation and effectiveness checks of major and critical quality events.
Archiving
Complete archiving activities as per standard operating procedure.