Newcastle University

Standard Operating Procedures Library

Templates

• SOP and WI reading log (Word doc: 35KB)
• Lead reviewer checklist (Word doc: 46KB)

General

• SOP GE-002-00 Training files (PDF: 32KB)
• SOP GE-001-02 Standard Operating Proceedure System (PDF: 31KB)
• WI GE-001-01-01 Writing a Standard Operating Procedure of Work Instruction (PDF: 33KB)

Trial Management

• SOP TM-001-00 Filing of Essential Documents (PDF: 41KB)
• WI TM-001-01-00 Trial Master File (PDF: 57KB)
• SOP TM-002-00 Request for a Clinical Trial Authorisation to the Competent Authority (PDF: 30KB)
• SOP TM-009-00 Clinical Studies Reports (PDF: 25KB)
• SOP TM-010-00 Protocol Development (PDF: 36KB)
• SOP TM-008-00 Obtaining a Favourable Opinion from the Ethics Committee for Health Research (PDF: 29KB)
• SOP TM-007-00 Patient Information Sheets and Consent Forms (PDF: 17KB)
• SOP TM-005-00 Site Recruitment and Initiation (PDF: 27KB)
• SOP TM-004-00 Monitoring a Research Study (PDF: 30KB)
• SOP TM-003-00 Sponsor Pharmacovigilance Responsibilities (PDF: 38KB)
• SOP TM- 011-00 Archiving (PDF: 35KB)
• SOP TM-012-00 Site Closure (PDF: 39KB)
• SOP TM-013-00 Notification of serious breaches of Good Clinical Practice (GCP) or the approved study protocol (PDF: 135KB)

Clinical

• Clinical Intervention and Clinical Measurements (PDF: 23KB)
• Emergency resuscitation procedures in the event of a cardiac arrest in Newcastle Clinical Ageing Research Unit (CARU) / Magnetic Resonance Centre (PDF: 44KB)

Statistics

• SOP ST-001-00 Statistical Validation of Clinical Trial Protocols and Case Report Forms (PDF: 32KB)
• SOP ST-002-00 Defining the Analysis Groups (PDF: 31KB)
• SOP ST-003-00 Statistical Analysis Plans (PDF: 32KB)
• SOP ST- 004-00 Randomisation and Blinding Procedures (PDF: 78KB)

Data Management

• SOP DM-006-00 Data Validation (PDF: 22KB)
• SOP DM-004-00 Data Capture Instrument Design (PDF: 23KB)
• SOP DM-003-00 Data Release (PDF: 21KB)
• SOP DM-002-00 Database Development (PDF: 21KB)
• SOP DM-001-00 Clinical Data Management System Specification (PDF: 21KB)
• SOP DM-005-00 Data Entry (PDF: 14KB)