8. Medical Labels or data allowing identification of device Device and Statement of device conformity Labs General description of product (if not in CIP) Results of design calculations, inspections and technical tests Correspondence Lab accreditations Reference ranges Sample storage logs 8.2 Labs Correspondence 9. Data Completed CRFs copy of CRF management 9.1 CRFs Superseded versions of CRF CRF Tracker Correspondence Validation checklist 9.2 Computer Validation documents Systems Correspondence Master randomisation list 9.3 Statistics Statistical Analysis Plan Correspondence 10. Meeting DMC charter 10.1 DMC DMC minutes Minutes Correspondence TSC charter 10.2 TSC TSC minutes Correspondence TMG minutes 10.3 TMG Correspondence Minutes 10.4 (list) Correspondence Full file review Review of Sponsor File TMF ISF Review completed by Date of review DD MMM YYYY List of documents required
8. Medical Device and Labs Labels or data allowing identification of device Statement of device conformity General description of product (if not in CIP) Results of design calculations, inspections and technical tests Correspondence 8.2 Labs Lab accreditations Reference ranges Sample storage logs Correspondence 9. Data management 9.1 CRFs Completed CRFs copy of CRF Superseded versions of CRF CRF Tracker Correspondence 9.2 Computer Systems Validation checklist Validation documents Correspondence 9.3 Statistics Master randomisation list Statistical Analysis Plan Correspondence 10. Meeting Minutes 10.1 DMC DMC charter DMC minutes Correspondence 10.2 TSC TSC charter TSC minutes Correspondence 10.3 TMG TMG minutes Correspondence 10.4 (list) Minutes Correspondence Full file review Review of Sponsor File TMF ISF Review completed by Date of review DD MMM YYYY List of documents required
CR001-T03%20Document%20checklist%20medical%20device%20v4.0.docx