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
CR003 Suspected Serious Breaches SOP Suspected Serious Breach Report Suspected Fraud/Misconduct Report
CR005 Identifying, Recording and Reporting Adverse Events and Urgent Safety Measures for CTIMPs SOP Cover Sheet and Return Receipt SAE Form CTIMP Pregnancy Notification Form 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 & CF Template PIS & CF AWI Template PIS & CF Recovered Template GP Letter Template Feasilbility Questionnaire 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 Violation Form Fax Cover Sheet - Protocol Deviation Log violation Form
