CR001 Establishing and Maintaining Investigator Site Files, Trial Master Files and Sponsor Files SOP Delegation of TMF form Document Checklist CTIMP Document Checklist non-CTIMP Document Checklist Medical Device
CR004 Recording and Reporting Study Data SOP Source Data Plan Example Text for Medical Notes AWI Consent
CR005 Identifying, Recording and Reporting Adverse Events and Urgent Safety Measures for CTIMPs SOP Pregnancy Notification Form CTIMP SAE Form AE Flowchart - Reporting AE Flowchart - Identifying Parent Child SAE form (CTIMP) CTIMP AE Log Follow-Up Sign-Off
CR006 Identifying, Recording and Reporting Adverse Events and Urgent Safety Measures for Non-CTIMPs SOP Non-CTIMP SAE Form Adverse Event Flowchart - Reporting non-CTIMP AE log Non-CTIMP SAE FU Sign-Off
CR007 Study Documents SOP CTIMP Protocol Template Non-CTIMP Protocol Template PIS & CF Template PIS & CF AWI Template PIS & CF Recovered Capacity Template GP Letter Template Site Signature & Delegation Log Subject Pre-screening Log Consent Subject Status Log Study Specific Training Record Data Only Protocol Template Qualitative Protocol Template Qualitative UoE Protocol Template Qualitative UoE PIS and CF Medical Device Study Protocol Template Medical Device Study Investigator Brochure Template
CR010 Management of Protocol and GCP Deviations and Violations SOP Protocol / GCP Violation Reporting Form Protocol / GCP Deviation Log
