CR001 Establishing and Maintaining Investigator Site Files, Trial Master Files and Sponsor Files SOP Document Checklist CTIMP Document Checklist non-CTIMP Document Checklist Medical Device Delegation of TMF form
CR005 Identifying, Recording and Reporting Adverse Events and Urgent Safety Measures for CTIMPs SOP Cover Sheet and Return Receipt Pregnancy Notification Form SAE Form CTIMP AE Flowchart - Reporting AE Flowchart - Identifying Parent Child SAE Form (CTIMP) CTIMP AE Log CTIMP SAE Follow Up Sign-Off
CR006 Identifying, Recording and Reporting Adverse Events and Urgent Safety Measures for Non-CTIMPs SOP Cover Sheet and Return Receipt non-CTIMP SAE Form AE Flowchart - Reporting non-CTIMP AE log SAE non-CTIMP Follow-Up Sign-Off
CR007 Study Documents SOP CTIMP Protocol template Non-CTIMP Protocol template PIS and CF template PIS and CF AWI template PIS and CF Recovered Capacity Template GP Letter Template Site Signature & Delegation Log Subject Pre-screening Log Consent Subject Status Log Study Specific Training Record
CR010 Management of Protocol Deviations and Violations SOP Protocol Deviation Log Protocol Violations Reporting Form Fax Cover Sheet
