SOPs

Summary of the table's contents
SOP Number	SOP Title
BS001.04	Statistical Analysis Plan
BS002.04	Interim analysis
BS003.04	Randomisation
BS004.04	Final Statistical Analysis and Report

Summary of the table's contents
SOP Number	SOP Title
CR001.05	Development of Study Protocols and Protocol Amendments
CR002.05	Investigator Meetings
CR003.03	Clinical Trial Agreements
CR004.03	IMP Release, Management and Accountability – Essential Documents
CR005.06	Investigator Identification and Selection
CR006.05	Study Registration Procedures
CR007.07	Ethics Submissions
CR008.07	Creation and Maintenance of a Trial Master File
CR009.05	Investigator Site Files and Pharmacy Files
CR010.04	Participant Information Sheets and Informed Consent Forms
CR012.04	Study Specific Procedure Manuals
CR013.06	Initiation of Investigator Sites
CR014.03	Trial Oversight Committees
CR015.04	Site Monitoring
CR016.04	Safety Reporting for Clinical Trials of Investigational Medicinal Products (CTIMP) and Non-CTIMPs
CR017.06	Detection and Management of Non-Compliance at Investigational Sites
CR018.05	Site Close-out Visits
CR020.04	Local Research Applications in Multi Centre Studies
CR021.04	Clinical Trial Authorisation Applications
CR022.04	Serious Breaches of GCP and Protocol
CR023.02	Trial Closure and Archiving
CR024.02	Clinical Study Report
CR026.01	Fraud and Misconduct
CR027.01	Insurance and Indemnity for Clinical Trials
CR028.01	Serious Adverse Event Reporting and Safety for Medical Device Studies
CR029.01	Blinding and Unblinding

Summary of the table's contents
SOP Number	SOP Title
DM001.02	Data Management Plan
DM008.02	Data Coding Using Medical Dictionaries
DM010.01	Electronic Data Transfer

Summary of the table's contents
SOP Number	SOP Title
GA001.06	Preparation, Authorization, Control and Review of SOPs
GA002.06	Training Records
GA005.05	Facility Security
GA009.02	Data Protection and Confidentiality
GA010.01	ICTU Collaboration Process
GA011.02	Escalation Procedures

Summary of the table's contents
SOP Number	SOP Title
HR001.06	Staff Induction and Training
HR002.03	Staff Resignation

Summary of the table's contents
SOP Number	SOP Title
IN001.02	Writing Tests for InForm Clinical Trials during Trial Development
IN002.01	Testing of InForm Clinical Trials during Trial Development
IN004.02	Requirements Definition for InForm Trials
IN005.02	Design and Development of InForm Trials Using Central Designer
IN007.02	Database Lock for InForm Clinical Trials
IN008.01	InForm Data Entry
IN009.01	InForm Test Issue Management
IN010.01	End user training
IN014.01	User Support
IN015.01	InForm Release Management
IN017.01	Project Management for InForm Clinical Trials
IN019.01	InForm Automated Unblinding Process
IN020.02	InForm Randomisation
IN021.01	Requesting InForm Services
IN022.01	Archiving After Closure of a Clinical Trial
IN023.01	Writing Test Scripts for InForm V6
IN024.01	Testing of InForm V6 Clinical Trials during trial development
IN025.01	Requirements Definition for InForm V6 Clinical Trials
IN026.01	Design and Development of InForm V6 Trials using CD2

Summary of the table's contents
SOP Number	SOP Title
IT001.04	Backup and Restore of Electronic Data
IT002.02	Disaster Recovery
IT003.03	Validation of Computerised Systems for GCP Use
IT004.04	Computer Systems Security, Maintenance and Environmental Control
IT005.04	Inventory Procedures
IT006.01	Change Control of Computerised Systems for GCP Use
IT007.01	Validation Risk Assessment
IT008.01	Requirements Specification and Traceability
IT009.01	Validation Planning and Reporting for Computerised Systems
IT010.01	Testing of Computerised Systems for GCP Use
IT011.01	Test Incident Management

Summary of the table's contents
SOP Number	SOP Title
QA001.05	Internal Review of Quality Systems
QA002.05	Management of Regulatory Inspections
QA003.05	Procedures Governing the Process of Internal Audit
QA004.02	Risk Analysis

Imperial College London