We have developed several Standard Operating Procedures and Working Practice Documents to support the running of trials within the unit and to ensure compliance with the principles of Good Clinical Practice (GCP). Our procedures have been developed according to the specific work groups within ECTU. Administration Document ECTU_SOP_AD_01 Creating and Maintaining Staff Training Records v5.0 (750.86 KB / 0) Document AD001 - Training Record Review form v1.0 (31.29 KB / 0) Document AD002 - Training Log Template v4.0 (33.68 KB / 0 ) Document AD003 - ECTU Leavers Training Record Review v2.0 (32.86 KB / 0) Document AD-T006 CV Template v3.0 (72 KB / 0) Document AD-T007 File Note Template v1.0 (50.55 KB / 0) QA Document ECTU_SOP_ QA_01 QA Management of ECTU controlled Standard Operating Procedures Working Practice Documents (202.36 KB / PDF) Document ECTU_SOP_QA_02 Maintaining an Electronic Staff Training Record v1.0 (712.52 KB / 0) Document ECTU_WPD_QA_W1 Training Record Review of Electronic Staff Training Record (665.63 KB / PDF) Operations Document ECTU_SOP_OP_01 Development and Management of Policies SOP (Standard Operating Procedures) and WPD (Working Practice Documents (253.99 KB / PDF) Document ECTU_SOP_OP_15 Data Access Request and Application Management v3.0 (237.57 KB / 0 ) Document ECTU_SOP_OP_16 Management of Trial IMP Supplies v2.0 (752.35 KB / 0) Document ECTU_SOP_OP_17 Review of External Reports V2.0 (447.43 KB / 0) Document ECTU_SOP_OP_18_Applying for Project Extensions v1.0 (301.95 KB / 0 ) Document ECTU_SOP_OP_19 File and Email Access for External and Non-Substantive ECTU Staff v1.0 (231.23 KB / 0 ) Document ECTU_SOP_OP_20 Requests to Lock and Unlock a Study Database v1.0 (230.07 KB / 0) Document ECTU_SOP_OP_21 Project Closure Planning v1.0 (286.93 KB / 0) Document ECTU_WPD_OP_W1 Processing Payment Requests and Reconciliation of Study Transactions v3.0-1.pdf (303.2 KB / 0-1) IT Document ECTU_SOP_IT_01 Initial Set-up Procedure v3.0 (285.23 KB / 0) Document ECTU_SOP_IT_02 Feature Development v3.0 (567.52 KB / 0 ) Document ECTU_SOP_IT_03 Feature Release v3.0 (300.05 KB / 0) Document ECTU_SOP_IT_07 Unblinding Procedure v3.0 (246.83 KB / 0) Document ECTU_SOP_IT_08 Emergency Randomisation v4.0 (532.33 KB / 0 ) Document ECTU SOP_IT_13 Making a Database Inaccessible at the End of Study v3.0 (263.94 KB / 0 ) Document ECTU_SOP_IT_14 Management of Blinded and Unblinded User Access Roles v5.0 (261.9 KB / 0 ) Document ECTU_SOP_IT_23 Additional Requirements v2.0 (523.51 KB / 0 ) Document ECTU_SOP_IT_24 Database Lock v2.0 (285.97 KB / 0) Document ECTU_SOP_IT_25 Disaster Recovery Test v2.0 (521.03 KB / 0 ) Document ECTU_SOP_IT_26 Removal of Access for Staff leaving an ECTU IT Post v1.0 (275.72 KB / 0) REDCap Document ECTU_SOP_REDCap_01 REDCap Database Build Training and Administrator Access v3.0 (303.21 KB / 0) Document ECTU_SOP_REDCap_02 REDCap Database Specification for Initial Release v4.0 (243.94 KB / 0) Document ECTU_SOP_REDCap_03 Database Build Process v3.0 (270.16 KB / 0 ) Document ECTU_SOP_REDCAP_04 Study Database Validation v3.0 (246.3 KB / 0) Document ECTU_SOP_REDCap_05 Study Database Release v4.0 (226.36 KB / 0 ) Document ECTU_SOP_REDCAP_06 Requesting and Implementing a Change to a Study Database 3.0 (234.46 KB / 0) Document ECTU_SOP_REDCap_07 Management of Study Database Lock and unlock Requests v4.0 (307.45 KB / 0) Document ECTU_SOP_REDCap_10 REDCap Application Updates v2.0 (337.36 KB / 0 ) Document ECTU_SOP_REDCap_12 Assigning Access to the REDCap API v2.0.pdf (290.62 KB / 0) Document ECTU_WPD_REDCap_W1 Database Release Procedure v1.0 (316.68 KB / 0 ) Document ECTU_WPD_REDCap_W2 Requesting a Change to a Study Database v1.0 (462.32 KB / 0 ) Document ECTU_WPD_REDCap_W3 Database Lock and Unlock Procedures v1.0 (331.97 KB / 0) Data Management Document ECTU_SOP_DM_01 Data Management Procedures v3.0 (240.77 KB / 0) Document ECTU_SOP_DM_02 Designing a Specification to Record a Change of Status for a Study Participant v3.0 (197.68 KB / 0) Document ECTU_SOP_DM_04 ECTU Data Entry Identification and Procedures v2.0 (260.08 KB / 0 ) Document ECTU_SOP_DM_06 Query and Missing Data Management v2.0 (231.83 KB / 0 ) Document ECTU_SOP_DM_07 Document Version Control and Review_v2.0 (225.4 KB / 0) Document ECTU_SOP_DM_09 Data Management Plans (DMP) v1.0 (207.57 KB / 0) Document ECTU_SOP_DM_10 Data Quality Control (QC) Checks v1.0 (301.74 KB / 0 ) Document ECTU_SOP_DM_11 Data Cleaning v1.0 (243.43 KB / 0) Document ECTU_WPD_DM_W1 Preparing for and Completing Data QC Checks v3.0 (310.13 KB / 0) Document ECTU_WPD_DM_W2 Data Cleaning Procedures v2.0 (288.6 KB / 0 ) Statistics Document ECTU_SOP_ST_01 Sample Size Calculation v5.0 (415.7 KB / 0 ) Document ECTU_SOP_ST_02 Randomisation and Blinding Procedures v5.0 (689.23 KB / 0) Document ECTU_SOP_ST_03 Data Monitoring Committee v6.0 (223.47 KB / 0 ) Document ECTU_SOP_ST_04 Statistical Analysis Plans v7.0 (749.98 KB / 0 ) Document ECTU_SOP_ST_05 Statistical Analysis and Reporting v6.0 (425.22 KB / 0) Document ECTU_SOP_ST_06 Establishing and Maintaining a Statistics Master File (SMF) v4.0 (460.24 KB / 0 ) Document ECTU_SOP_ST_07 Defining Data Access Requirements for Blinded and Unblinded Statisticians v4.0 (438.79 KB / 0 ) Document ECTU_WPD_ST_W1 General Guidelines v4.0 (749.08 KB / 0 ) Document ECTU_WPD_ST_W2 Statistical Input into Trial and Protocol Design v4.0 (680.47 KB / 0) Document ECTU_WPD_ST_W3 DMC Reporting v5.0 (270.54 KB / 0) Document ECTU_WPD_ST_W4 Additional Guidance on the Contents of a Statistical Analysis Plan (SAP) v4.0 (817.19 KB / 0 ) Document ECTU_WPD_ST_W5 Statistical Analysis and Reporting v5.0 (458.8 KB / 0 ) Document ECTU_WPD_ST_W6 Randomisation System Description and Confirmation v2.0 (658.69 KB / 0) Trial Management Document ECTU_SOP_TM_02_Agreements v6.0 (251.22 KB / 0) Document ECTU_SOP_TM_03 Obtaining Approvals v6.0 (267.88 KB / 0 ) Document ECTU_SOP_TM_08 Preparing for Trial Steering Committee Meetings v7.0 (449.68 KB / 0) Document ECTU_SOP_TM_09 Planning for a Participant Withdrawal or Change of Status v5.0 (237.7 KB / 0 ) Document ECTU_SOP_TM_12 Preparing for Data Monitoring Committee (DMC) Meetings v6.0 (774.31 KB / 0) Document ECTU_SOP_TM_14 End of Trial Notification and Trial Close-Out v3.0 (703.83 KB / 0) Document ECTU_SOP_TM_18 Creating and Maintaining a Pharmacy Site File (PSF) v3.0 (282.46 KB / 0) Document ECTU _SOP_TM_19 TM Handover Guidance v5.0.pdf (350.23 KB / 0) Document ECTU_SOP_TM_20 Provision of ISFs to Study Sites v2.0 (649.85 KB / 0) Document ECTU_SOP_TM_21 Evidencing Competency, Training and Delegation of Tasks in the TM Team v2.0 (280.7 KB / 0) Document ECTU_WPD_TM_W2 Archiving of Essential Study Documentation v4.0 (284.34 KB / 0 ) Document ECTU_WPD_TM_W4 Requesting and Recording Protocol Deviation Logs and Protocol Violations in ACCORD Sponsored Studies. v2.0 (299.67 KB / V2) Document ECTU_WPD_TM_W5_Processing Site Payments v1.0 (288.4 KB / 0) Document ECTU_WPD_TM_W6 Preparing maintaining and reviewing the Trial Master File and Investigator Site Files v1.0 (253.08 KB / 0 ) Any queries regarding our SOP and WPD can be sent to qa.ectu@ed.ac.ukTrials that are co-sponsored between University of Edinburgh and NHS Lothian should also be conducted in accordance with the Sponsor SOPs. These can be found on the ACCORD website here. This article was published on 2024-09-24
