SOPs
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 Number | SOP Title |
---|---|
BS001.04 | Statistical Analysis Plan |
BS002.04 | Interim analysis |
BS003.04 | Randomisation |
BS004.04 | Final Statistical Analysis and Report |
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 |
Data Management
SOP Number | SOP Title |
---|---|
DM001.02 | Data Management Plan |
DM008.02 | Data Coding Using Medical Dictionaries |
DM010.01 | Electronic Data Transfer |
General
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 |
Human Resources
SOP Number | SOP Title |
---|---|
HR001.06 | Staff Induction and Training |
HR002.03 | Staff Resignation |
InForm
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 |
Information Technology
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 |
Quality Assurance
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 |