Standard Operating Procedures

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

ECTU_SOP_AD_01 Creating and Maintaining Staff Training Records v5.0 (750.86 KB PDF)

• QA

ECTU_SOP_ QA_01 QA Management of ECTU controlled Standard Operating Procedures Working Practice Documents and their Periodic Review v2.0 (202.36 KB PDF)

• Operations

ECTU_SOP_OP_01 Development and Management of Policies SOP (Standard Operating Procedures) and WPD (Working Practice Documents v7.0 (253.99 KB PDF)

ECTU_SOP_OP_15 Data Access Request and Application Management v3.0 (237.57 KB PDF)

ECTU_SOP_OP_16 Management of Trial IMP Supplies v2.0 (752.35 KB PDF)

ECTU_SOP_OP_17 Review of External Reports v1.0 (647.1 KB PDF)

ECTU_SOP_OP_18_Applying for Project Extensions v1.0 (301.95 KB PDF)

ECTU_SOP_OP_19 File and Email Access for External and Non-Substantive ECTU Staff v1.0 (231.23 KB PDF)

ECTU_SOP_OP_20 Requests to Lock and Unlock a Study Database v1.0 (230.07 KB PDF)

ECTU_WPD_OP_W1 Processing Payment Requests and Reconciliation of Study Transactions v2.0 (664.78 KB PDF)

• IT

ECTU_SOP_IT_01 Initial Setup Procedure v2.0 (189.86 KB PDF)

ECTU_SOP_ IT_02 Feature Development v2.0 (191.26 KB PDF)

ECTU_SOP_ IT_03 Feature Release v2.0 (175.74 KB PDF)

ECTU_SOP_IT_06 Paper-based Treatment Allocation v2.0 (225.59 KB PDF)

ECTU_SOP_IT_07 Unblinding Procedures v2.0 (167.59 KB PDF)

ECTU_SOP_IT_08 Emergency Randomisation v3.0 (99.75 KB PDF)

ECTU_SOP_IT_13 Database Archiving v2.0 (183.03 KB PDF)

ECTU_SOP_IT_14 Management of Blinded and Unblinded User Access Roles v4.0 (548.38 KB PDF)

ECTU_SOP_IT_23 Additional Requirements v1.0 (170.79 KB PDF)

ECTU_SOP_IT_24 Database Lock v1.0 (166.26 KB PDF)

ECTU_SOP_IT_25 Disaster Recovery Test v1.0 (681 KB PDF)

ECTU_WPD_IT_W1 Database Archiving v2.0 (167.81 KB PDF)

ECTU_WPD_IT_W2 Granting Blinded or Unblinded Access to a Study Database v4.0 (539.89 KB PDF)

• REDCap

ECTU_SOP_REDcap_01 Build Process - Training (167.75 KB PDF)

ECTU_SOP_REDCap_02 Initial Specification v3.0 (585.5 KB PDF)

ECTU_SOP_REDcap_03 Build Process - Individual Instrument v2.0 (199.16 KB PDF)

ECTU_SOP_REDcap_04 Project Level Validation v2.0 (168.67 KB PDF)

ECTU_SOP_REDcap_05 Project Release v3.0 (186.43 KB PDF)

ECTU_SOP_REDcap_06 Project Modifications v2.0 (174.1 KB PDF)

ECTU_SOP_REDcap_07 Database Lock v3.0 (178.34 KB PDF)

ECTU_SOP_REDcap_08 Software Installation and Database Backup v2.0 (172.34 KB PDF)

ECTU_SOP_REDcap_09 Project Lock - Sectional Database Lock v1.0 (173.98 KB PDF)

ECTU_SOP_REDCap_10 REDCap Updates v1.0 (200.98 KB PDF)

ECTU_SOP_REDCap_11 REDCap Backup v1.0 (158.84 KB PDF)

ECTU_SOP_REDCap_12 Assigning Access to the REDCap API v1.0 (645.72 KB PDF)

• Data Management

ECTU_SOP_DM_01 Data Management Procedures v3.0 (240.77 KB PDF)

ECTU_SOP_DM_02 Designing a Specification to Record a Change of Status for a Study Participant v3.0 (197.68 KB PDF)

ECTU_SOP_DM_04 Data Entry Procedures v1.0 (749.92 KB PDF)

ECTU_SOP_DM_05 Data Quality v1.0 (750.47 KB PDF)

ECTU_SOP_DM_06 Query and Missing Data Management v2.0 (231.83 KB PDF)

ECTU_SOP_DM_07 Document Version Control and Review_v2.0 (225.4 KB PDF)

ECTU_SOP_DM_09 Data Management Plans (DMP) v1.0 (207.57 KB PDF)

ECTU_WPD_DM_W1 Data Quality Checks v2.0 (796.43 KB PDF)

ECTU_WPD_DM_W2 Data Cleaning v1.0 (752.02 KB PDF)

• Statistics 

ECTU_SOP_ST_01 Sample Size Calculation v4.0 (532.89 KB PDF)

ECTU_SOP_ST_02 Randomisation and Blinding Procedures v5.0 (689.23 KB PDF)

ECTU_SOP_ST_03 Data Monitoring Committee v6.0 (223.47 KB PDF)

ECTU_SOP_ST_04 Statistical Analysis Plans v7.0 (749.98 KB PDF)

ECTU_SOP_ST_05 Statistical Analysis and Reporting v6.0 (425.22 KB PDF)

ECTU_SOP_ST_06 Establishing and Maintaining a Statistics Master File (SMF) v3.0 (661.92 KB PDF)

ECTU_WPD_ST_W1 General Guidelines v4.0 (749.08 KB PDF)

ECTU Central Office WPD_ST_W2: Statistical Input into Trial and Protocol Design v4.0 (680.47 KB PDF)

ECTU_WPD_ST_W3 DMC Reporting v5.0 (270.54 KB PDF)

ECTU_WPD_ST_W4 Additional Guidance on the Contents of a Statistical Analysis Plan (SAP) v4.0 (817.19 KB PDF)

ECTU_WPD_ST_W5 Statistical Analysis and Reporting v5.0 (458.8 KB PDF)

ECTU_WPD_ST_W6 Randomisation System Description and Confirmation v2.0 (658.69 KB PDF)

• Trial Management

ECTU_SOP_TM_02_Agreements v6.0 (251.22 KB PDF)

ECTU_SOP_TM_03 Obtaining Approvals v6.0 (267.88 KB PDF)

ECTU_SOP_TM_08 Preparing for Trial Steering Committee Meetings v6.0 (682.06 KB PDF)

ECTU_SOP_TM_09 Planning for a Participant Withdrawal or Change of Status v5.0 (237.7 KB PDF)

ECTU_SOP_TM_12 Preparing for Data Monitoring Committee (DMC) Meetings v6.0 (774.31 KB PDF)

ECTU_SOP_TM_14 End of Trial Notification and Trial Close-Out v3.0 (703.83 KB PDF)

ECTU_SOP_TM_18 Creating and Maintaining a Pharmacy Site File v2.0 (661.28 KB PDF)

ECTU _SOP_TM_19 Trial Manager Handover Guidance v5.0 (243.77 KB PDF)

ECTU_SOP_TM_20 Provision of ISFs to Study Sites v2.0 (649.85 KB PDF)

ECTU_SOP_TM_21 Training and Delegation of tasks in the Trial Management Team v1.0 (650.34 KB PDF)

ECTU_WPD_TM_W2 Archiving of Essential Study Documentation v4.0 (284.34 KB PDF)

ECTU_WPD_TM_W4 Requesting and Recording Protocol Deviation Logs and Protocol Violations in ACCORD Sponsored Studies. v1.0 (670.82 KB PDF)

ECTU_WPD_TM_W5_Processing Site Payments v1.0 (288.4 KB PDF)

ECTU_WPD_TM_W6 Preparing maintaining and reviewing the Trial Master File and Investigator Site Files v1.0 (253.08 KB PDF)

• Any queries regarding our SOP and WPD can be sent to qa.ectu@ed.ac.uk
• Trials 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.