This page contains current supporting documents and templates for the running of clinical trials within the unit Operations (OP) Document OP-F01 Review of External Report Checklist v2.0 (21.73 KB / 0) Document OP-F02 - Data Access Request Application Form Type A v3.0 (43.64 KB / 0) Document OP-F03 Data Access Request Application Form Type B v3.0 (42.62 KB / 0) Document OP-F04 ECTU Study Database Lock Checklist v2.0 (46.93 KB / 0) Document OP-T01 ECTU External Handover v1.0 (52.96 KB / 0) Document OP-T05 Project Closure Plan Template v1.0 (63.58 KB / 0) Document OP-T06 File Note Template v1.0 (47.77 KB / 0) IT Document IT001 Database Access Record Log Template v2.0 (29.48 KB / 0) Document IT002 Database Lock Template v2.0 (28.9 KB / 0) Document IT003 System Release Template v4.0 (133.3 KB / 0) Document IT004 Additional Requirements Template v1.0 (35 KB / 0) Document IT005 Risk Assessment Template v1.0 (32.6 KB / 0) Document IT006 System Level Security Policy Template v1.0 (253.55 KB / 0) Document IT007 Programmer Leaving Record v2.0 (29.01 KB / 0) Document IT008 Disaster Recovery Test Template v2.0 (45.52 KB / 0) Document IT009 Bespoke Study Database Validation Plan Template v1.0 (52.42 KB / 0) REDCap Document RC001 REDCap Training Log Template draft v1.0 (55.23 KB / 0) Document RC002 REDCap Database Build Exercise v1.0 (68.21 KB / 0) Document RC003 REDCap Database Build Exercise EQ5D5L v1.0 (255.45 KB / 0) Document RC004 REDCap Database Build Exercise HAQ v1.0 (1.74 MB / 0) Document RC005 REDCap Database Build Excercise PSQI v1.0 (912.02 KB / 0) Document RC006 REDCap Database Build Exercise BPI v1.0 (784.47 KB / 0) Document RC007 REDCap Database Build Exercise SF36 v1.0 (2.69 MB / 0) Document RC008 REDCap Database Development Guide v1.0 (Word) (1.08 MB / 0 (WORD)) Document RC009 REDCap Study Database Release Specification Template v1.0 (53.37 KB / 0) Document RC010 REDCap Study Database Validation Plan Template v1.0 (51.39 KB / 0) Document RC011 REDCap Study Database Validation Document Core Functionality Template v1.0 (57.51 KB / 0) Document RC012 REDCap Study Database Validation Document Instruments Template v1.0 (51.25 KB / 0) Document RC013 REDCap Study Database Lock Log Template v1.0 (50.86 KB / 0) Document RC014 REDCap Study Database Unlock Log Template v1.0 (49.77 KB / 0) Document RC015 REDCap Study Database Removal of Functionality Log Template v1.0 (50.69 KB / 0) Document RC016_Development REDCap Update Checklist Template v2.0 (43.16 KB / 0) Document RC017_Production REDCap Update Checklist Template v2.0 (45.95 KB / 0) Data Management (DM) Document DM001 Data Management Plan Template v7.0 (73.76 KB / 0) Document DM005 Data Entry Guidelines Template v3.0 (Word) (54.79 KB / 0 (WORD)) Document DM006 Data Quality Control Check Plan Template v3.0 (53.75 KB / 0) Document DM007 Data Quality Control Check Final Report Template v5.0 (49.75 KB / 0) Document DM008 Query and Missing Data Guidelines Bespoke Template v3.0 (52.16 KB / 0) Document DM009 Query Contact List Template v3.0 (37.99 KB / 0) Document DM011 QC Check Overview Template v2.0 (49.94 KB / 0) Document DM012 Data Cleaning Plan Template v2.0 (53.27 KB / 0) Document DM014 Data Cleaning Log Template v2.0 (57.33 KB / 0) Document DM015 File Note Data Cleaning Documentation Template v1.0 (48.19 KB / 0) Document DM016 File Note Query Report and Email Notification Template v1.0 (47.04 KB / 0) Document DM017 Query and Missing Data Guidelines REDCap Template v1.0 (52.19 KB / 0) Document DM018 ECTU Data Management Handover Log Template v1.0 (55.98 KB / 0) Statistics (ST) Document ST001 - Sample Size Estimate Form Template v5.0 (43.72 KB / 0) Document ST002 - Randomisation System Description and Confirmation Document Template v5.0 (47.59 KB / 0) Document ST003 - Example DMC Report v5.0 (390.8 KB / 0) Document ST004 - SAP Template v6.0 (59.08 KB / 0) Document ST005A - Final Report - Analysis Population Agreement v3.0 (42.49 KB / 0) Document ST005B - Final Report Authorisation Template v4.0 (43.39 KB / 0) Document ST005C - Interim Report Authorisation Template v1.0 (43.35 KB / 0) Document ST006A - SMF Essential Document Checklist Template v5.0 (50.14 KB / 0) Document ST006B - SMF Divider Labels v3.0 (19.58 KB / 0) Document ST006C - SMF Spine Label Template v2.0 (46.77 KB / 0) Document ST007 - Statistical Review Checklist v4.0 (44.11 KB / 0) Trial Management (TM) Templates Document TM001 - Non-CTIMP ISF Table of Contents Template v3.0 (36.59 KB / 0) Document TM002 - CTIMP ISF Table of Contents Template v3.0 (40.81 KB / 0) Document TM003 - ISF Receipt Template v2.0 (47 KB / 0) Document TM004 - Document Amendment Receipt Template v2.0 (46 KB / 0) Document TM-F01 - Delegation of TM Activity v1.0 (52.12 KB / 0) Document TM-T2 - TMF ISF Index Template v3.0 (44.8 KB / 0) Document TM-T3 - TMF lever arch file label Template (14.12 KB / DOCX) Document TM-T4 - ISF lever arch file label Template (14.46 KB / DOCX) Document TM-T5 - ECTU File Note Log v2.0 (56.07 KB / 0) Document TM-T10 - Cover email for sending contracts to site RD (16.34 KB / DOCX) Document TM-T11 - ECTU Pharmacy Manual Template v2.0 (62.1 KB / 0) Document TM-T12 - Certificate of attendance v1.0 (47.52 KB / 0) Document TM-T13 - eCRF access request form v3.0 (60.5 KB / 0) Document TM-T15 - Deviation Site Training Slides v3.0 (268.5 KB / 0) Document TM-T17 - Newsletter template v2.0 (4.17 MB / 0) Document TM-T19a - ECTU Letterhead Update v2.0 (302.5 KB / 0) Document TM-T20 - Trial Supplies Receipt for PPD v3.0 (46.5 KB / 0) Document TM-T21 - QC Check of study Packs tracked v3.0 (45.2 KB / 0) Document TM-T22 - Trial Supplies Request Form v2.0 (21.84 KB / 0) Document TM-T25 - Essential Study Information v5.0 (36.23 KB / 0) Document TM-T26 - Study Management Guidebook Template v5.0 (66.57 KB / 0) Document TM-T28 - End of Trial Meeting Agenda v2.0 (27.12 KB / 0) Document TM-T29 - Master IMP Inventory Log Template v2.0 (46.91 KB / 0) Document TM-T30 - Participant IMP Accountability Log Template v2.0 (66.45 KB / 0) Document TM-T31 - Pharmacy Signature Log Template v2.0 (47.59 KB / 0) Document TM-T32 - Pharmacy Site File Contents Template v2.0 (32.57 KB / 0) Document TM-T33 - Prescription Template v2.0 (39.33 KB / 0) Document TM-T34 - Temperature Log Template v2.0 (50.92 KB / 0) Document TM-T35 - Treatment Allocation Log v2.0 (44.71 KB / 0) Document TM-T37a - ECTU Powerpoint Template (889.85 KB / PPTX) Document TM-T37b - ECTU Powerpoint Template (88.11 KB / PPTX) Document TM-T37c - ECTU Powerpoint Template (282.68 KB / PPTX) Document TM-T38 - ECTU DMC Charter Template v3.0 (64.6 KB / 0 ) Document TM-T39 - TSC Charter Template v2.0 (70.83 KB / 0) Document TM-T40 File Note Electronically Filed TMF Documents Template v1.0 (46.75 KB / 0) Trackers Document TM-T7 Contact List v2.0 (18.5 KB / 0) Document TM-T8 CV_GCP Training tracker v2.0 (21.9 KB / 0) Document TM-T9 Site set up tracker v1.0 (17.77 KB / 0) Document TM-T14 Amendment Tracker v2.0 (16.88 KB / 0) Document TM-T16 Deviation Request Tracker v3.0 (21.46 KB / 0) Document TM-T18 Invoice Tracker v2.0 (26.04 KB / 0) Document TM-T24 ECTU Close Out Tracker v3.0 (32.27 KB / 0) Document TM-T36 Recruitment Project Plan Tracker Template v2.0 (213.68 KB / 0) Working Instructions (WI) Document Template Work Instruction v1.0 (88 KB / 0) Document TM005 Alignment of Tasks to Staff Grade within ECTU TM Team v1.0 (57.02 KB / 0) Document TM-WI2 ECTU Study Email v3.0 (97.5 KB / 0) Document TM-WI3 Meeting Coordination v3.0 (124.5 KB / 0) Document TM-WI4 Sample pack preparation Template v3.0 (46.53 KB / 0) Document TM-WI5_Team DelegationSignature log v2.0 (51.33 KB / 0) Document TM-WI6 ECTU Merchandise and study incentives v3.0 (570.6 KB / 0) Document TM-WI7a Template Work Instruction Marken Ltd Courier booking process v2.0 (540 KB / 0) Document TM-WI7b Template Work Instruction WORLD COURIER booking process v2.0 (166 KB / 0) Quality Assurance (QA) Document QA002a (QA) ECTU Core SOP Read Receipt v9.0 (37.57 KB / 0) Document QA002b (TM) ECTU Core SOP Read Receipt v9.0 (40.28 KB / 0) Document QA002c (DM) ECTU Core SOP Read Receipt v10.0 (43.89 KB / 0) Document QA002d (ST) ECTU Core SOP Read Receipt v10.0 (43.29 KB / 0) Document QA002f (HE) ECTU Core SOP Read Receipt v3.0 (38.15 KB / 0) Document QA002g (BUS) ECTU Core SOP Read Receipt v9.0 (39.78 KB / 0) Document QA002h (IT) ECTU Core SOP Read Receipt v9.0 (42.33 KB / 0) Document QA002j (OP) ECTU Core SOP Read Receipt v10.0 (40.74 KB / 0) Document QA002z ECTU Core SOP Read Receipt v2.0 (39.03 KB / 0) Document QA004 CV Template v1.0 (75.5 KB / 0) This article was published on 2026-01-12
