https://www.gosh.nhs.uk/our-research/our-research-infrastructure/joint-research-and-development-office-rd/clinical-trials/standard-operating-procedures-sops-and-forms/
Standard operating procedures (SOPs) and forms
This page contains the Great Ormond Street Hospital (GOSH) and UCL Institute of Child Health (ICH) SOPs for guidance and instruction in setting up and running clinical trials, as well as forms for reporting adverse events and a template for writing a protocol.
Clinical Research:
For all staff working on Clinical Research
Training Requirement for Staff Participating in Clinical Research
SOP:
Training Requirements for Staff Participating in Clinical Research
Related documents:
- GOSH/ICH/SD/R/001: Written Procedure Matrix
- GOSH/ICH/TMP/R/003: Study Specific Training Record – Group
- GOSH/ICH/TMP/R/004: Study Specific Training Record – Individual
- SOP read and acknowledgement record template
Archiving
SOP:
Related documents
- GOSH/ICH/TMP/R/005: File Note Template
- GOSH/ICH/TMP/R/005A: File Note Template Regarding Adverse Event Logs
- GOSH/ICH/TMP/R/005B: File Note Template Regarding Final Study Report
- SOP/R/006: Study Documentation and Monitoring, Audit and Inspection
- GOSH/ICH/FRM005: Study Content Archive Spreadsheet Template
Study Document and Monitoring, Audit and Inspection
SOP:
Study Document and Monitoring, Audit and Inspection
Related documents:
- GOSH/ICH/TMP/R/005: File note template
- SOP/R/005: Reporting and Escalation for Research
- SOP/R/002: Training Requirements for Staff Participating in Clinical Research
- GOSH/ICH/SOP/R/003: CSV for Systems used in Research
Investigator Site Research Team Responsibilities
SOP:
Investigator Site Research Team Responsibilities
Related documents:
- GOSH/ICH/SD/R/002: PI Code of Practice
- SOP/R/002: Training Requirements for Staff Participating in Clinical Research
- SOP/R/005: Reporting and Escalation for Research
- GOSH/ICH/SOP/R/006: Study Documentation and Monitoring, Audit and Inspection
Writing, Approval, Distribution, Control and Review of Written Procedures
SOP:
Writing, Approval, Distribution, Control and Review of Written Procedures
Related documents:
- GOSH/ICH/SOP/R/006: Study Documentation and Monitoring, Audit and Inspection
- GOSH/ICH/TMP/R/001: Written Procedure Template
- GOSH/ICH/TMP/R/002: Supporting Document Template
- GOSH/ICH/SD/R/001: Written Procedure Matrix
- SOP/R/002: Training Requirements for Staff Participating in Clinical Research
GOSH Sponsored Projects:
For all staff working on GOSH Sponsored projects
- Relevant for all GOSH sponsored research
Computer Systems Validation (CSV) for Systems used in Research
SOP:
Computer Systems Validation (CSV) for Systems used in Research
Related Documents:
- GOSH/ICH/SOP/R/004: Archiving
- GOSH/ICH/TMP/R/006: CSV Risk Assessment Template
- GOSH/ICH/TMP/R/007: CSV Validation Plan Template
- GOSH/ICH/TMP/R/008: CSV Testing Sheet Template
- GOSH/ICH/TMP/R/009: CSV Validation Report Template
- GOSH/ICH/TMP/R/001: Written Procedure Template
Assessment and Confirmation of Implementation of Amendments to Hosted and GOSH/ICH Sponsored CTIMPs and non-CTIMPs
SOP:
Related Documents
- SOP/R/005: Reporting and Escalation for Research
- GOSH/ICH/TMP/R/057: Change Control Form
Essential Documents for Trials Master File and Investigator Site File for GOSH Sponsored Trials
SOP:
Essential Documents for Trials Master File and Investigator Site File for GOSH Sponsored Trials
Related Documents
- GOSH/ICH/SOP/R/004: Archiving
- GOSH/ICH/SOP/R&D/006: GOSH Monitoring CTIMP Projects
- End of Study Reporting Requirements SOP [under review, to be added when approved]
- Appendix 1: Trial Master File Structure (Multicentre)
- Appendix 2: Trial Master File Structure (Single Site)
- Appendix 3: Investigator Site File Structure
- Appendix 4:Essential Documents Checklist
- Appendix 5: Close Out Essential Documents Checklist
- Relevant for CTIMPs projects
Sponsorship Approval for GOSH Sponsored Clinical Trials
SOP:
Sponsorship Approval for GOSH Sponsored Clinical Trials
Related Documents:
- CTIMP Risk Assessment form
- CT:SC Terms of Reference
Pharmacovigilance and Safety Reporting
SOP:
Pharmacovigilance and Safety Reporting
Related Documents
- SAE Reporting form version 6
- Pregnancy Reporting Form
- ICH/06/F20/version 3: Other Important Safety Issues Reporting Form
- RSI Assessment Form
- GOSH/ICH/SOP/R/005: Amendments
- Reference to DSUR and APR Report
- GOSH/ICH/FRM/R/014: Managing Blinding and Unblinding
- Monitoring SOP for IDMC
Monitoring of CTIMPs by GOSH (Sponsor)
SOP:
Monitoring of CTIMPs by GOSH (Sponsor)
Related Documents
- GOSH/ICH/SOP/R&D/001: Sponsorship Approval for GOSH Sponsored Clinical Trials
- GOSH/ICH/TMP/R/005: File note template
- Management of Serious Breaches occurred in Clinical Trials of Investigational Medicinal Products SOP.
- Monitoring Plan Template
- Trial Initiation Report Template
- Monitoring Report Template
- Monitoring Report Pharmacy Template
- End of Trial Monitoring Report Template
- Monitoring Detailed Findings Log
- Detailed Pharmacy Findings Log
- GOSH Sponsored-Managed CTIMPs Monitoring Tracker
- GOSH Sponsored-Managed CTIMPs Annual Reporting Tracker
- Relevant for non-CTIMPs projects
Identification and Approval of Sponsorship for non-CTIMPs
SOP:
Identification and Approval of Sponsorship for non-CTIMPs
Related Documents:
- GOSH and ICH (UCL) Non-Commercial Sponsorship Flowchart
- Steps to Sponsor's Electronic Authorisation of IRAS Form
CRF Studies:
For PIs and Investigators for CRF studies
Clinical Research Facility (CRF) Operations
SOP:
Clinical Research Facility (CRF) Operations
Related Documents:
- CRF Safety Checklist
- SOP/R/002: Training Requirements for Staff Participating in Clinical Research
- CRSM Terms of Reference
- SOP/CRF/001: Ordering, Storage and Administration of Medicines In the CRF
- SOP/CRF/005 Storage of Research Samples in the CRF Prep Lab
Trust Policy:
For all researchers
Trust Policy
Please note the following is not an exhaustive list of Trust policies.
All Trust policies can be found on the internal Our GOSH policy webpage.
If you cannot access the GOSH intranet, the documents are also available upon request: Research.Governance@gosh.nhs.uk
- Consent Policy – Shared Decision Making in Healthcare and Research
- Sending Samples from Wards to Camelia Botnar Laboratory (Sample Transport SOP)
- Storing Samples for Research: Compliance with the Human Tissue Act
- Health and Safety Policy
- Health Record Management policy
- Corporate Records Management Policy
- Freedom of Information Act Policy
- Information Governance and Data Protection Policy
- Dignity at Work Policy
- Raising a Matter of Concern Policy (Whistleblowing)
- Safety Event/Incident Reporting & Management Policy