Standard operating procedures (SOPs) and forms

This page contains the Great Ormond Street Hospital (GOSH)/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.

SOPs Template Forms

GOSH-ICH-05-CT01-V11-CTIMP sponsorship.pdf (2.77 MB)

GOSH-ICH16-CT02-V1- Regulatory Greenlight.pdf (1.62 MB)

GOSH-ICH-06-CT03-V5- Essential Documents.pdf (2.83 MB)

GOSH-ICH-07-CT05-V5-SOP for the design of a CRF.pdf (2.68 MB)

GOSH-ICH-05-CT06-V8- Recording and Reporting of AE and ARs that arise during.pdf (5.39 MB)

GOSH-ICH-06-CT19-V9- Pharmacovigilance SOP for RD Office.pdf

GOSH-ICH-SOP-R-002 - V2 - Training requirement for research staff.pdf

GOSH-ICH-05-CT09-V7 Submission of the Development Safety Update Report to the MHRA and the Annual Safety and Annual Progress.pdf (4.79 MB)

GOSH-ICH-07-CT10-V3 Amendments to a GOSH sponsored CTIMP.pdf (3.17 MB)

31. GOSH-ICH-08-RG31-V4-Amendments to hosted and GOSHICH sponsored non-CTIMP studies_0.pdf

GOSH-ICH-06-CT11-V5 Subject Screening, Enrolment and Identification Logs.pdf (1.86 MB)

GOSH-ICH-11-CT12-V3 Management of Serious Breaches occurred in Clinical Trials of Investigational Medicinal Products.pdf (2.96 MB)

GOSH-ICH-SOP-R-003 - V2 - Computer system validation.pdf

GOSH-ICH-16-CT14-V1-End of Study Reporting Requirements.pdf (5.95 MB)

GOSH-ICH-16-CT15-V1-Vendor Management for GOSH Sponsored Clinical Trials.pdf (5.48 MB)

GOSH-ICH-SOP-R-034 - V1 -Informed Consent for Research.pdf

GOSH-ICH-SOP-R-035 - V1 - Dose Escalation.pdf

GOSH-ICH-SOP-R-037 -V1 -Unblinding.pdf

GOSH-ICH-SOP-RD-027 - V9 - RD permissions.pdf

GOSH-ICH-SOP-R-001 - V2 - SOP writing procedure.pdf

GOSH-ICH-SOP-R&D - 018 - V6 - CRAC.pdf

GOSH-ICH-SOP-R&D - 024 - V7 - Data Protection.pdf

GOSH-ICH-SOP-R&D-025 - V7 - Human Tissue Act compliance management.pdf

GOSH-ICH-06-CT08-V8- Monitoring CTIMPs.pdf

30. GOSH-ICH-13-RG30-V3-Audit SOP.pdf

GOSH-ICH-16-CT18-V2- Managing CAPA's.pdf

23. GOSH-ICH-15-RG23-V2-Research misconduct.pdf

28. GOSH-ICH-15-RG28-V2 Honorary Research Contracts and Letters of Access SOP.pdf

17.GOSH-ICH-05-RG17-V7-Archiving.pdf

Trial Protocol template (458.5 KB)

44. SAE_R_Reporting_Form_Version_5.docx

Form 20: Report of Other Important Safety Issues (244.18 KB)

Form 45: Pregnancy Reporting Form (176 KB)