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
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
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
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
- GOSH/ICH/SOP/R/004: Archiving
- GOSH/ICH/FRM/R/001: Monitoring/Audit Checklist
- GOSH/ICH/SOP/R&D/009: Annual Reporting for GOSH Sponsored Studies
SOP:
GOSH Sponsored Projects
For all staff working on GOSH Sponsored projects
Relevant for all GOSH sponsored 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
- GOSH/ICH/TMP/R/010: CSV Change Control Template
- GOSH/ICH/TMP/R/011: CSV Change Assessment Template
SOP:
Related Documents
- SOP/R/005: Reporting and Escalation for Research
- GOSH/ICH/TMP/R/057: Change Control Form
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
- GOSH/ICH/SOP/R&D/011: End of Study Reporting Requirements SOP
- 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
SOP:
SOP:
- Relevant for CTIMPs projects
SOP:
Sponsorship Approval for GOSH Sponsored Clinical Trials
Related Documents:
- CTIMP Risk Assessment form
- CT:SC Terms of Reference
SOP:
Pharmacovigilance and Safety Reporting
Related Documents
- SAE Reporting form version 6
- -regnancy 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
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
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
SOP:
Clinical Research Facility (CRF) Operations
Related Documents:
- CRF Safety Checklist
- SOP/R/002: Training Requirements for Staff Participating in Clinical Researc-CRSM Terms of Reference
- SOP/CRF/002: Booking Appointments, Admission, Discharge and Transfer of Study Participants in the CRF
- 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
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