Procedures for conducting clinical studies, ensuring compliance with ethical, regulatory, and scientific standards. CR001 Establishing and Maintaining Investigator Site Files, Trial Master Files and Sponsor Files Document CR001 Establishing and Maintaining ISFs, TMFs and Sponsor Files v6.0 (526.73 KB / PDF) Document CR001-F01 Delegation of TMF Form v1.0 (138.5 KB / DOC) Document CR001-T01 Document Checklist CTIMP v7.0 (95.89 KB / DOCX) Document CR001-T02 Document Checklist Non CTIMP v8.0 (81.97 KB / DOCX) Document CR001-T03 Document Checklist Medical Device v7.0 (86.28 KB / DOCX) CR003 Suspected Serious Breaches Document CR003 Suspected Serious Breaches v6.0 (1.09 MB / 0) Document CR003-F01 Suspected Serious Breach Report v2.0 (152.91 KB / 0) CR004 Recording and Reporting Study Data Document SOP v6.0 (242.45 KB / PDF) Document CR004-T01 Source Data Plan v2.0 (244.63 KB / DOCX) Document CR004-T02 Example Text for Medical Notes AWI Consent v1.0 (29.55 KB / DOCX) CR005 Identifying, Recording and Reporting Adverse Events and Urgent Safety Measures for CTIMPs Document CR005 Identifying, Recording and Reporting AEs and USMs for CTIMPs v8.0 (948.67 KB / 0) Document CR005-F02 Pregnancy Notification Form v9.0 (189.58 KB / 0) Document CR005-T01 CTIMP SAE Form v8.0 (200.3 KB / 0) Document CR005-T02 AE Flowchart - Reporting v4.0 (167.27 KB / 0) Document CR005-T03 AE Flowchart - Identifying v4.0 (166.76 KB / 0) Document CR005-T04 Parent Child SAE Form (CTIMP) v4.0 (199.58 KB / 0) Document CR005-T05 CTIMP AE Log v4.0 (183.2 KB / 0) Document CR005-T06 Follow-Up Sign-Off v2.0 (173.7 KB / 0) CR006 Identifying, Recording and Reporting Adverse Events and Urgent Safety Measures for Non-CTIMPs Document CR006 Identifying, Recording and Reporting AEs and USMs for Non-CTIMPs v9.0 (597.68 KB / 0) Document CR006-T01 Non CTIMP SAE Form v7.0 (186.19 KB / 0) Document CR006-T02 AE Flowchart - Reporting v5.0 (164.59 KB / 0) Document CR006-T03 Non CTIMP AE Log v2.0 (179.06 KB / 0) Document CR006-T04 Non CTIMP Follow-Up Sign-Off v2.0 (173.59 KB / 0) CR007 Study Documents Document CR007 Study Documents v7.0 (239.13 KB / PDF) Document CR007-T01 CTIMP Protocol Template v10.0 (219.03 KB / 0) Document CR007-T02 Non CTIMP Protocol Template v6.0 (187.13 KB / 0) Document CR007-T03 PIS and Consent Form Template v9.0 (175.79 KB / 0) Document CR007-T04 PIS and Consent Form AWI Template v9.0 (174.38 KB / 0) Document CR007-T05 PIS and Consent Form Recovered Capacity Template v9.0 (173.49 KB / 0) Document CR007-T06 GP Letter Template v2.0 (84 KB / DOC) Document CR007-T12 Site Signature & Delegation Log v3.0 (104.8 KB / DOCX) Document CR007-T13 Subject Pre-Screening Log v2.0 (94.69 KB / DOCX) Document CR007-T14 Consent Subject Status Log v2.0 (95.49 KB / DOCX) Document CR007-T17 Study Specific Training Record v2.0 (96.95 KB / DOCX) Document CR007-T19 Data Only Protocol Template v2.0 (173.18 KB / 0) Document CR007-T20 Qualitative Protocol Template v2.0 (185.14 KB / 0) Document CR007-T21 Qualitative UoE Protocol Template v1.0 (184.34 KB / 0) Document CR007-T22 Qualitative UoE PIS and Consent Form Template v2.0 (167.41 KB / 0) Document CR007-T23 Medical Device Protocol Template v1.0 (232.65 KB / 0) Document CR007-T24 Medical Device Study Investigator Brochure Template v1.0 (176.85 KB / 0) CR008 Preparing and Submitting Progress and Safety Reports Document CR008 Preparing and Submitting Progress and Safety Reports v9.0 (872.72 KB / PDF) Document CR008-T01 DSUR Template v2.0 (100.44 KB / DOCX) CR009 Study Closure and Archiving Document CR009 Study Closure and Archiving v6.0 (424.36 KB / PDF) Document CR009-F01 Study Closure Checklist v2.0 (108.05 KB / DOCX) CR010 Management of Protocol and GCP Deviations and Violations Document CR010 Management of Protocol and GCP Deviations and Violations v8.0 (886.99 KB / 0) Document CR010-F01 Protocol/GCP Violation Reporting Form v6.0 (163.68 KB / 0) Document CR010-T01 Protocol/GCP Deviation Log v5.0 (166.43 KB / 0) Document CR010-WI01 Deviation Log Spot Checks v3.0 (157.13 KB / 0) Document CR010-WI01-F01 Deviation Log Reconciliation Form v2.0 (157.87 KB / 0) Document CR010-WI01-F02 Deviation Reporting Spot Check v2.0 (167.53 KB / 0) SOP CR010 v8.0 Training CR011 Research Study Reports and Publication of Results Document CR011 Research Study Reports & Publication of Results v5.0 (904.26 KB / 0) CR012 Identifying, Recording and Reporting Adverse Events and Device Deficiencies Document CR012 Identifying, Recording And Reporting AEs and Device Deficiencies v5.0 (924.28 KB / 0) Document CR012-T01 SAE CIMD Form v4.0 (189.48 KB / 0 ) Document CR012-T02 Medical Device Deficiency Form v4.0 (180.44 KB / 0) CR013 CRF Design and Implementation Document CR013 CRF Design and Implementation v5.0 (475.75 KB / PDF) Document CR013-T01 CRF Review v6.0 (86.83 KB / DOCX) Document CR013-T02 CRF Version Tracker v3.0 (96.7 KB / DOCX) Document CR013-T03 Template Instructions & Front Page v1.0 (31.61 KB / DOCX) Document CR013-T03 Template Screening Visit v1.0 (189.88 KB / DOCX) Document CR013-T03 Template Baseline Visit v1.0 (120.98 KB / DOCX) Document CR013-T03 Template Study Visit v1.0 (134.53 KB / DOCX) Document CR013-T03 Template PI Sign Off v1.0 (38.63 KB / DOCX) Document CR013-T03 Template Concomitant Medications v1.0 (61.34 KB / DOCX) Document CR013-T03 Template Co-Enrolment v1.0 (39.89 KB / DOCX) Document CR013-T03 Template Change of Status v1.0 (45.65 KB / DOCX) CR014 Suspected Research Misconduct Document CR014 Suspected Research Misconduct v5.0 (889.18 KB / PDF) Document CR014-F01 Suspected Fraud/Misconduct Report v2.0 (151.94 KB / DOCX) CR015 Data Monitoring Committee and Trial Steering Committee Charters Document CR015 DMC and TSC Charters v4.0 (875.91 KB / 0) Document CR015-T01 Data Monitoring Committee Charter v4.0 (165.18 KB / 0) Document CR015-T02 Trial Steering Committee Charter v3.0 (161.96 KB / 0) CR016 Dose Progression and Stopping Rules Document CR016 Dose Progression and Stopping Rules v1.0 (457.52 KB / PDF) Document CR016-F01 Dose Progression Decision Form v1.0 (64.59 KB / DOCX) CR017 Organisational Information Document Completion Document CR017 Organisational Information Document Completion v4.0 (692.36 KB / 0) CR018 Management of Complaints Document CR018 Management of Complaints v2.0 (565.94 KB / 0) Document CR018-F01 Service User Complaint Form v2.0 (152.3 KB / 0) Document CR018-T01 Complaint Investigation Report v2.0 (151.79 KB / 0) This article was published on 2024-11-07
