SOPs and Associated Documents-Templates
The Research Governance and Integrity Team (RGIT) has produced Standard Operating Procedures (SOPs) and associated templates for Imperial College investigators and research staff, governing the management and operational aspects of conducting clinical research.
This section contains the RGIT approved:
- Standard Operating Procedures (SOPs)
- Associated document: covers guidance and templates associated with the RGIT SOPs
- Non-associated documents (which may cover guidance notes or templates etc)
Please note, all SOPs are referenced with RGIT_SOP_XXX and the associated templates are referenced with RGIT_TEMP_XXX. The SOPs are all in PDF format and the SOPs are generic, please adapt them to make study-specific procedures. The associated documents and templates will be made available in Word format for ease of completion.
Please refer to this page often as the most up-to-date version of each SOP will appear on this page. If you have any questions please contact a member of the RGIT.
Please note the new IRAS system for CTIMP studies will be mandated by the HRA from 1st January 2022, the RGIT will therefore not be accepting old IRAS application forms for sponsorship review from the 1st October 2021. Information on the new system can be found here.
SOP, Associated Documents/Templates
Protocols
Ethics and consent
RGIT_SOP_002_Ethics_Approval_for_Health_Related_Research_v10.pdf
- RGIT_TEMP_007_Research Governance and Integrity Team Contact Details_v2.docx
- RGIT_TEMP_008_Summary-of-Where-to-Apply-for-Ethics-Approval_v2.docx
RGIT_SOP_006_Amendments_V12.pdf
RGIT_SOP_003_Applying for NHS REC Approval.pdf
RGIT_SOP_016_Informed_Consent_v.20.pdf
- RGIT_TEMP_031_Guide-to-Writing-a-Participant-Information-Sheet_v.7.docx
- RGIT_TEMP_032-Template-ICF-for-Adults-with-Capacity_V6.docx
- RGIT_TEMP_033_Template-ICF-for-Adults-without-Capacity_V7.docx
- RGIT_TEMP_034-Template-ICF-for-Parent-legal-guardian-minor rep._V6.docx
Imperial College Healthcare Trust
NIHR studies
Safety reporting
RGIT_SOP_001_Safety_Reporting_v13.pdf
- RGIT_TEMP_003_Example Serious Adverse Event form_V4.docx
- RGIT_TEMP_004_Safety Reporting Overview_v2.docx
- RGIT_TEMP_006_CTIMPs Safety Report Form_v3.docx
RGIT_SOP_021_Serious Breach Reporting_v9.pdf
RGIT_SOP_035_Development Safety Update Report.pdf
RGIT_SOP_037_Deviations_Violations_USM_v7.pdf
RGIT_SOP_041_ Annual_Progress_Report_v5.pdf
Essential documentation and TMF
Case Report Form
Sponsorship and indemnity
RGIT_SOP_009_AHSC_approval_V14.pdf
- RGIT_TEMP_019_CI-agreement-for-CTIMPs_V2.docx
- RGIT_TEMP_020_Risk-Assessment-Tool_V2.docx
- RGIT_TEMP_021_Sponsorship-and-Insurance-Request-Form_V17.docx
- RGIT_TEMP_022_OID-Contracts-Flowchart-_v.6.docx
- RGIT_TEMP_054_CTIMP-Addendum-Risk-Assessment_ V9.docx
- RGIT_TEMP_057_Sponsorship-and-Insurance-Approval-email_V11.docx
- RGIT_TEMP_058_Statistical-Engagement-Letter_V1.docx
- RGIT_TEMP_062_Process Map for OID and SoECATs.pdf
Approval bodies
RGIT_SOP_004_GTAC_application_v10.pdf
RGIT_SOP_014_Medical Device.pdf
RGIT_SOP_017_CAG_application_V12.pdf
RGIT_SOP_023_HFEA License Applications_v9.pdf
RGIT_SOP_039_HRA_Approval_v6.pdf
RGIT_SOP_050_Medical Device Safety Reporting.pdf
- RGIT_TEMP_005_SAE Reporting Form for non-IMP studies.docx
- RGIT_TEMP_063_Medical Device SAE Reporting Form.docx
- RGIT_TEMP_064_Medical Device Report Form.docx
Monitoring and audit
Trial management
RGIT_SOP_013_Participant_Complaints_v9.pdf
RGIT_SOP_019_Archiving_v10.pdf
RGIT_SOP_020_Data_Management_v11.pdf
RGIT_SOP_022_Public Databases.pdf
RGIT_SOP_026_IMP Management.v10.pdf
- RGIT_TEMP_037_Study Delegation Log_v.3.docx
- RGIT_TEMP_038_Subject Dispensing and Return Accountability Log.v3.docx
- RGIT_TEMP_039_Drug Accountability Log.v3.docx
- RGIT_TEMP_040_Investigational Medicinal Product Destruction Log.v.3.docx
- RGIT_TEMP_051_Annex 13 labelling requirements for CTIMPs.v2.docx
RGIT_SOP_027_Equipment_Maintenance_v9.pdf
RGIT_SOP_029_Laboratory_Procedures_v9.pdf
RGIT_SOP_030_Computerised Systems.pdf
Research passports
Research misconduct
Other
RGIT_SOP_011_SOP_Writing Reviewing_v10.pdf
- RGIT_TEMP_001_SOP Read and Acknowledge Signature Log_V3.docx
- RGIT_TEMP_023_SOP Template_V3.docx
- RGIT_TEMP_024_Statement of Compliance to RGIT SOPs v3.docx
- RGIT_TEMP_025_RGIT Log of approved waivers v3.xlsx
RGIT_SOP_040_Peer_Review_v4.pdf
RGIT_SOP_028_End_of_Study_Procedure_V14.pdf
- RGIT_TEMP_041_Notification End of Clinical Trial Medicine_V3.docx
- RGIT_TEMP_042_Declaration of the End of a study_V5.docx
RGIT_SOP_042_Incidental Findings_v3.pdf
RGIT_SOP_043_Electronic Signature.pdf