Below is a list of ICTU's current Standard Operating Procedures (SOPs). Please expand on the title-bars for further detail.

SOP List

Biostatistics

SOP NumberSOP 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

Clinical Research

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

Data Management

SOP NumberSOP Title
 DM001.02  Data Management Plan
 DM008.02  Data Coding Using Medical Dictionaries
 DM010.01  Electronic Data Transfer
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General

SOP NumberSOP 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

Human Resources

SOP NumberSOP Title
 HR001.06  Staff Induction and Training
 HR002.03  Staff Resignation
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InForm

SOP NumberSOP 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

Information Technology

SOP NumberSOP 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

Quality Assurance

SOP NumberSOP 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
Summary of the table's contents