Reference Number Template 1 Staff Signatures and Delegation Log (DOC, 90 KB) 2 Staff Meeting Log (DOC, 76 KB) 3a INDIVIDUAL TRAINING RECORD (DOC, 82 KB) 3b GROUP TRAINING RECORD (DOC, 84KB) 4 Short CV (DOC, 86 KB) 5 Site Feasibility Checklist (DOC, 77KB) 6 Site Risk Assessment Toolkit (XLS, 865 KB) 7 Protocol Deviation and Violation Report Form (DOC, 91 kb) 9 File Notes (DOC, 89 KB) 10 Data Management Plan (DOC, 408 KB) 11 ESSENTIAL Document Log (DOC, 72 KB) 12 Patient Master Index (XLS, 31 KB) 13 Data Closure Form (DOC, 81 KB) 14 Adverse Event Form (XLS, 18 KB) 14a Adverse Event Coding Sheet (DOC, 93 KB) 15 Corrective Action Sheet (XLS, 13 KB) 16 Monitoring Log (DOC, 74 KB) 17 Randomisation Registration Notification (DOC, 89 KB) 18 Unblind Request Form (DOC, 91 KB) 19 Unblind Report Notification (DOC, 84 KB) 20 Trial Master File Index (DOC, 95 KB) 21 Study Feasibility Checklist (DOC, 77 KB) 24 Dissemination Plan (DOC, 75 KB) 25 Data Requests Log (DOC, 71 KB) 27 Pilot Study Progress Plan (DOC, 82 KB) 29 Study Closure Checklist (DOC, 85 KB) 29a Study Closure Checklist (each site) (DOC, 85 KB) 29b Study Closure Checklist (all sites) (DOC, 83 KB) 30 SOP Development Template (DOC, 92 KB) 31a PaCCSC New Study Proposal (DOC, 180 KB) 31b CST New Study Proposal (DOC, 202 KB) 32a PaCCSC New Study Proposal Evaluation (DOC, 120 KB) 32b CST New Study Evaluation (DOC, 141 KB) 33 Site Initiation Program - Existing sites (DOC, 97 KB) 34 Site Initiation Program - new sites (DOC, 100 KB) 35 Study Monitoring Plan (DOC, 128 KB) 36 Study Recruitment Plan (DOC, 104 KB) 37 Recruitment Review (DOC, 81 KB) 38 Recruitment Phone Calls (DOC, 83 KB) 39 ISF index (DOC, 138 KB) 40 Serious Adverse Event Report (DOC, 105 KB) 41 Training Compliance Form (DOC, 82 KB) 43 DSMC reporting template (doc, 140 kb) 44 SAe summary sheet (xls, 14 kb) 45 protocol violation log (xls, 16 kb) 46 Qualitative research costing (DOC, 80 KB) 47 forms and documents (doc, 78kb) 50 itcc data closure checklist (Doc, 86 kb)
