Governance
STU has implemented a Quality Management System (QMS) to help provide a framework for assuring the quality of all research study activities. The QMS ensures that working practices within STU are reviewed and improved and we can learn from instances that don’t go as planned.
All research processes are detailed within Standard Operating Procedures (SOPs) to help ensure that activities are completed in a uniform and consistent manner as required by Good Clinical Practice (GCP) and all applicable regulations and guidelines.
STU SOP Categories:
Administration
Data Management & Statistics
IT
Project Set-Up
Trial Management
Project Closure
Policies
Standard Operating Procedures
SOPs: Administration | |||||
SOP Number | SOP Title | Associated Documents | |||
STU-SOP-ADM-001 | SOP on SOPs | STU-AD-TMP-002 | SOP Template | ||
STU-SOP-ADM-002 | Document Control | STU-AD-TMP-003 | Version Control Log | ||
STU-SOP-ADM-003 | STU Establishing & Maintaining a Training Record | ||||
| | | ||||
STU-SOP-ADM-005 | Adoption of Research Projects | | | ||
STU-SOP-ADM-008 | STU Quality Management System | | | ||
STU-SOP-ADM-009 | Audit | STU-AD-FRM-034 | CAPA Signature Sheet | | |
Return to TopSOPs: Data Management and Statistics | |||||
SOP Number | SOP Title | Associated Documents | |||
STU-SOP-DMS-001 | Randomisation | STU-AD-TMP-007 STU-AD-TMP-007 | Randomisation Specification Template | ||
STU-SOP-DMS-002 | Blinding and Unblinding | STU-AD-GDN-004 | Recommendations for Generating Allocation Identifiers | ||
| STU-AD-TMP-013 | Allocation to Randomisation Checklist | ||||
| STU-AD-FRM-012 | Site Unblinding Request Log | ||||
STU-SOP-DMS-003 | Qualitative Analysis Quality Assurance | STU-AD-TMP-014 | QA of Qual Analysis Log | ||
| STU-AD-TMP-015 | Q-DAP Template | ||||
STU-SOP-DMS-004 | Creating a Statistical Analysis Plan | STU-AD-TMP-009 | Statistical Analysis Plan Template | ||
STU-SOP-DMS-005 | Creating a Qualitative Data Analysis Plan (Q-DAP) | STU-AD-TMP-015 | Q-DAP Template | ||
STU-SOP-DMS-006 | Patient Reported Outcome Measures | STU-AD-FRM-013 | PROMs Considerations | ||
STU-SOP-DMS-007 | CRF Development | ||||
| STU-AD-TMP-003 | Version Control Log | ||||
| STU-AD-GDN-007 | CRF Design Guidelines | ||||
| STU-AD-FRM-017 | CRF Approval Form | ||||
| STU-AD-TMP-023 | CRF Library | ||||
| STU-AD-TMP-024 | CRF Completion Guidelines | ||||
| STU-AD-TMP-025 | Data Management Plan | ||||
STU-SOP-DMS-008 | Data Management | STU-AD-TMP-025 | Data Management Plan Template | ||
| STU-AD-TMP-026 | Database Specification Document | ||||
| STU-AD-TMP-027 | Data Validation Plan Template | ||||
STU-SOP-DMS-009 | Database Development & Maintenance | STU-AD-TMP-026 | Database Specification Document | ||
| STU-AD-TMP-028 | Database Test Plan Template | ||||
| STU-AD-TMP-027 | Data Validation Plan Template | ||||
| STU-AD-FRM-019 | Move to Production Approval | ||||
| STU-AD-TMP-029 | Screen Testing Template | ||||
| STU-AD-FRM-020 | Database Change Request Form | ||||
| STU-AD-TMP-030 | UAT Checklist Template | ||||
STU-SOP-DMS-010STU-SOP-DMS-012 | Data Locking & ReleaseSharing Participant Research Data | STU-AD-FRM-025 | Data Lock Request Form | ||
| STU-AD-FRM-026 | Data Unlocking Request Form | ||||
| STU-AD-FRM-027 | Data Release Request Form Data Sharing Request Form | ||||
Return to TopSOPs: IT | |||||
SOP Number | SOP Title | Associated Documents | |||
STU-SOP-IT-001 | Validation of Computerised Systems | STU-AD-TMP-031 | Validation Plan Template | ||
STU-SOP-IT-003 | IT Management | STU-AD-FRM-024 | User account form | ||
| Not available online | Notification templates | ||||
Return to TopSOPs: Project Set-Up | |||||
SOP Number | SOP Title | Associated Documents | |||
STU-SOP-TS-012STU-SOP-TS-013 | Capacity and CapabilityContract requirements for Non-Commercial Research Projects | None | None | ||
STU-SOP-TS-002 | TSC and DMC requirements | STU-AD-TMP-010 | TSC charter template | ||
| STU-AD-TMP-011 | Damocles DMC Charter Template | ||||
STU-SOP-TS-003 | Research Project Operational Committees | STU-AD-TMP-012 | Terms of reference template | ||
STU-SOP-TS-004 | Selection and Oversight of Vendors | STU-AD-FRM-014 | Vendor Assessment Questionnaire | ||
| STU-AD-TMP-018 | Laboratory Services Requirements | ||||
| STU-AD-FRM-015 | Vendor Competency Questionnaire | ||||
STU-SOP-TS-005 | Risk Assessment | STU-AD-TMP-049 | Risk Assessment Proforma | ||
STU-SOP-TS-006 | Site Selection & Initiation | STU-AD-TMP-019 | Delegation Log Template | ||
| STU-AD-FRM-016 | Site Expression of Interest Form | ||||
| STU-AD-TMP-020 | SIV Agenda Template | ||||
| STU-AD-TMP-021 | SIV Attendance Log Template | ||||
| STU-AD-TMP-022 | Site Initiation Report Proforma | ||||
STU-SOP-TS-007 | Regulatory Green Light Process | STU-AD-FRM-021 | Site Green Light Form | ||
| STU-AD-FRM-022 | Trial Green Light Form | ||||
STU-SOP-TS-008 | Writing a Research Protocol to Good Clinical Practice | STU-AD-TMP-039 | Non-CTIMP Protocol Template | ||
STU-SOP-TS-009 | Applying for Ethics Approval | None | None | ||
| None | None | ||||
STU-SOP-TS-011 | Submitting a CTA for a CTIMP | None | None | ||
Return to TopSOPs: Trial Management | |||||
SOP Number | SOP Title | Associated Documents | |||
STU-SOP-TM-001 | Safety Reporting in CTIMPs | ||||
| STU-AD-TMP-008 | Adverse Event Log | ||||
| STU-AD-FRM-008 | SAE Report | ||||
| STU-AD-FRM-009 | Pregnancy Form | ||||
| | | ||||
STU-SOP-TM-002 | Developing and maintaining a Trial Master File for CTIMPs and Other Research | STU-AD-GDN-005 | Essential Documents Index | ||
| STU-AD-TMP-003 | Version Control Log | ||||
| STU-AD-TMP-016 | File Note Template | ||||
| STU-AD-TMP-017 | File Note Log | ||||
STU-SOP-TM-003 | Developing and maintaining an Investigator Site File for CTIMPs and Other Research | STU-AD-GDN-005 | Essential Documents Index | ||
| STU-AD-TMP-003 | Version Control Log | ||||
| STU-AD-TMP-016 | File Note Template | ||||
| STU-AD-TMP-017 | File Note Log | ||||
STU-SOP-TM-004 | Obtaining Informed Consent from Competent Adults | STU-AD-TMP-019 | Delegation Log Template | ||
STU-SOP-TM-005 | Consent for Adults Lacking Capacity | STU-AD-TMP-019 | Delegation Log Template | ||
STU-SOP-TM-006 | Data Protection & Confidentiality in Research Projects | STU-AD-FRM-018 | Data Transfer | ||
STU-SOP-TM-007 | Annual Progress Reports and Development Safety Update Reports | STU-AD-GDN-008 | ICH Guideline E2F on DSUR | ||
| STU-AD-FRM-023 | DSUR Template | ||||
STU-SOP-TM-008 | Informed Consent in a Paediatric Setting | None | None | ||
STU-SOP-TM-009 | Monitoring | STU-AD-TMP-035 | Monitoring plan template | ||
| STU-AD-TMP-036 | Monitoring report template | ||||
| STU-AD-GDN-009 | Types of monitoring guidance | ||||
| STU-AD-TMP-037 | Source data location list | ||||
| STU-AD-TMP-038 | Medical records monitoring checklist | ||||
| STU-AD-TMP-049 | RA Proforma | ||||
STU-SOP-TM-010 | Summary of Product Characteristics, Investigator Brochure and Investigational Medicinal Product Dossier | STU-AD-TMP-040 | IB Template | ||
STU-SOP-TM-011 | Identifying and Assessing Deviations, Breaches and Urgent Safety Measures | STU-AD-FRM-028 | Deviations, Breaches & USMs Log | ||
| STU-AD-FRM-029 | Breach reporting form | ||||
| STU-AD-FRM-030 | USM Notification form | ||||
STU-SOP-TM-012 | Management of Medicinal Products (MP) used in CTIMPs and Other Research | STU-AD-FRM-032 | MP Request Form | ||
| STU-AD-TMP-043 | Example IMP form | ||||
| STU-AD-TMP-041 | Accountability Log | ||||
| STU-AD-TMP-042 | Research Project Prescription Form | ||||
| STU-AD-FRM-012 | Emergency Unbinding Template | ||||
| STU-AD-FRM-031 | MP Order form | ||||
| STU-AD-FRM-022 | Green Light Form | ||||
STU-SOP-TM-013 | Preparation for a GCP Regulatory Inspection | None | None | ||
STU-SOP-TM-014 | Managing a change in Chief Investigator | None | None | ||
STU-SOP-TM-015 | Managing Submission of Non-Substantial and Substantial Amendments | Non | Non | ||
Return to TopSOPs: Project Closure | |||||
SOP Number | SOP Title | Associated Documents | |||
STU-SOP-TC-001 | Preparation and Management of Archived Clinical Research Data | STU-AD-GDN-001 | Archive Guidance | ||
| STU-AD-FRM-001 | Archive Transfer Form | ||||
| STU-AD-TMP-001 | Archive Box Label Template | ||||
| STU-AD-FRM-002 | Archive Retrieval Form | ||||
| STU-AD-FRM-003 | Archive Destruction Form | ||||
STU-SOP-TC-002 | Trial closure including Suspension or Early Termination | STU-AD-TMP-033 | Site Closure Checklist | ||
Return to TopPolicies | |||||
SOP Number | SOP Title | Associated Documents | |||
STU-POL-001 | Patient and Public Involvement in Research | None | None | ||
STU-POL-002 | STU Information Technology | None | None | ||
STU-POL-003 | Identifying and Managing Research Misconduct | None | None | ||