Notification to R&D End of report 2.7 NHS Lothian R&D Documents and correspondence Documents specific to R&D procedures 3. Contracts Co-sponsorship agreement 3.1 Sponsorship and Co-sponsorship letter and Funding Insurance Facilitation checklist Insurance letter/statement Technical agreements Agreements Site agreements Other (list) Funding application Funding letter Correspondence 4. Participant 4.1 Subject log Documents 4.2 Consent 5. Safety Unblinding procedure 5.1 Unblinding Broken Blinds SAE/SADE/USADE and device deficiency reports PhV SOPs/WPDs 5.2 Safety reporting Line listings Blank safety reporting forms Correspondence DSUR 5.3 DSUR Covering letter Acknowledgement 5.4 Protocol Violation reports Violations Correspondence 5.5 Protocol Deviations logs Deviations Correspondence 6. Research 6.1 Delegation log Team Investigator CV 6.2 Investigator GCP certificate 6.3 Other relevant training 6.4 Site contact list 7. Monitoring ACCORD combined RA and Audit Superseded combined RAs 7.1 Risk Assessments Other risk assessment (list) Correspondence Monitoring plan 7.2 Monitoring Plan Superseded monitoring plans Correspondence SIV (report and letter) Monitoring visit report Monitoring visit follow up letter Close out visit report 7.3 Monitoring Close out visit follow up letter Reports Action logs Documentation of recruitment checks Correspondence Contact reports Observations 7.4 Audit Certificate Correspondence Vendor assessment 7.5 Vendors Correspondence Current IB 8.1 Medical Device Superseded IBs
Notification to R&D End of report 2.7 NHS Lothian R&D Documents Documents and correspondence specific to R&D procedures 3. Contracts and Funding 3.1 Sponsorship and Insurance Co-sponsorship agreement Co-sponsorship letter Facilitation checklist Insurance letter/statement Agreements Technical agreements Site agreements Other (list) Funding Funding application letter Correspondence 4. Participant Documents 4.1 Subject log 4.2 Consent 5. Safety 5.1 Unblinding Unblinding procedure Broken Blinds 5.2 Safety reporting SAE/SADE/USADE and device deficiency reports PhV SOPs/WPDs Line listings Blank safety reporting forms Correspondence 5.3 DSUR DSUR Covering letter Acknowledgement 5.4 Protocol Violations Violation reports Correspondence 5.5 Protocol Deviations Deviations logs Correspondence 6. Research Team 6.1 Delegation log 6.2 Investigator CV Investigator GCP certificate 6.3 Other relevant training 6.4 Site contact list 7. Monitoring and Audit 7.1 Risk Assessments ACCORD combined RA Superseded combined RAs Other risk assessment (list) Correspondence 7.2 Monitoring Plan Monitoring plan Superseded monitoring plans Correspondence 7.3 Monitoring Reports SIV (report and letter) Monitoring visit report Monitoring visit follow up letter Close out visit report Close out visit follow up letter Action logs Documentation of recruitment checks Correspondence Contact reports 7.4 Audit Observations Certificate Correspondence 7.5 Vendors Vendor assessment Correspondence 8.1 Medical Device Current IB Superseded IBs
CR001-T03%20Document%20checklist%20medical%20device%20v4.0.docx