SOP, 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
Imperial College Healthcare Trust
NIHR studies
Safety reporting
RGIT_SOP_001_Safety Reporting.pdf
- RGIT_TEMP_003_Serious Adverse Event Reporting Form.docx
- RGIT_TEMP_004_Safety Reporting Overview.docx
- RGIT_TEMP_005_SAE Reporting Form for non-IMP studies.docx
- RGIT_TEMP_006_CTIMPs Safety Report Form.docx
RGIT_SOP_021_Serious Breach Reporting.pdf
RGIT_SOP_035_Development Safety Update Report.pdf
Essential documentation and TMF
Case Report Form
Sponsorship and indemnity
RGIT_SOP_009_Sponsorship and Insurance Approval.pdf
- RGIT_TEMP_019_CI agreement for CTIMPs.docx
- RGIT_TEMP_020_Risk Assessment Tool_V2.0_19Oct2020.docx
- RGIT_TEMP_021_Sponsorship and Insurance Request Form.docx
- RGIT_TEMP_022_OID Contracts Flowchart (App.5).docx
- RGIT_TEMP_054_CTIMP_Addendum-Risk-Assessment.docx
- RGIT_TEMP_057_Sponsorship-and-Insurance-Approval-email.docx
- RGIT_TEMP_058_Statistical Engagement Letter.docx
- RGIT_TEMP_062_Process Map for OID and SoECATs.pdf
Approval bodies
Monitoring and audit
Trial management
RGIT_SOP_013_Participant Complaints.pdf
RGIT_SOP_020_Data_Management.pdf
RGIT_SOP_022_Public Databases.pdf
RGIT_SOP_026_IMP Management.pdf
- RGIT_TEMP_037_Study Delegation Log.docx
- RGIT_TEMP_038_Subject Dispensing and Return Accountability Log.docx
- RGIT_TEMP_039_Drug Accountability Log.docx
- RGIT_TEMP_040_Investigational Medicinal Product Destruction Log.docx
- RGIT_TEMP_051_Annex 13 labelling requirements for CTIMPs.docx
RGIT_SOP_027_Equipment Maintenance.pdf
Research passports
Research misconduct
Other
RGIT_SOP_011_SOP Writing Reviewing.pdf
- RGIT_TEMP_001_SOP Read and Acknowledge Signature Log.docx
- RGIT_TEMP_002_All SOP Read and Acknowledge Signature Log.docx
- RGIT_TEMP_023_SOP Template.docx
- RGIT_TEMP_024_Statement of Compliance to RGIT SOPs.docx
- RGIT_TEMP_025_RGIT Log of approved waivers.xlsx
RGIT_SOP_028_End of Study Procedure.pdf
- RGIT_TEMP_041_Notification End of Clinical Trial Medicine.docx
- RGIT_TEMP_042_Declaration of the End of a Study.docx
RGIT_SOP_042_Incidental Findings.pdf
RGIT_SOP_043_Electronic Signature.pdf
RGIT_SOP_046 Database Lock.pdf
RGIT_SOP_047_Secure Image Capture & Export for Research using Pando.pdf