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Standard Operating Procedures

SOP reference number

SOP title 

Process for writing standard operating procedures (SOPs) for Research Governance Procedures for research (PDF, 66KB)

Sponsor Review process (PDF, 189KB)

Appendix 1a: Obsolete

Appendix 1b: Obsolete

Appendix 2: Sponsor Peer Review Form (Word, 34KB)


Sponsor risk assessment and management of research (PDF, 161KB)

Appendix 1: Risk assessment form (Word, 118KB)

Appendix 2: Sponsor review checklist (risk assessed) (Word, 67KB)

Appendix 3: Sponsor review checklist (non-risk assessed) (Word, 55KB)

Appendix 4: Risk assessment flowchart (PDF, 409KB)

Sponsor contracts management (PDF, 144KB)
Process to ensure NHS permission is received for Research Sponsored by the University of Leicester (PDF, 165KB)

Site management (monitoring) for University of Leicester when acting as Sponsor (PDF, 256KB)

Appendix 1: Monitoring plan (PDF, 659KB)

Appendix 2: Monitoring strategy table (PDF, 606KB)

Appendix 3: Monitoring visit log (PDF, 408KB)

Appendix 4: Source data agreement (PDF, 447KB)

Appendix 5: CTIMP monitoring visit report (PDF, 428KB)

Appendix 6: Obsolete

Appendix 7: Non-CTIMP monitoring visit report (PDF, 406KB)

Appendix 8: Remote monitoring report (PDF, 1201KB)

Appendix 9: Remote pharmacy monitoring report (PDF, 890KB)

Appendix 10: Monitoring plan for non-CE marked devices (Word, 61KB)

Appendix 11: Monitoring visit CAPA (PDF, 168KB)

Appendix 12: CE marked PoC device trial monitoring visit report (PDF, 1642KB)

Appendix 13: Remote pharmacy drug reconciliation (PDF, 89KB)


Processing and reporting of serious adverse events, serious adverse reactions and suspected unexpected serious adverse reactions (PDF, 199KB)

Appendix 1: Pregnancy reporting form (Word, 60KB)

Appendix 2: CTIMP multicentre line listing (PDF, 122KB)

Appendix 3: Non-CTIMP multicentre line listing (PDF, 143KB)

Appendix 4: Obsolete

Appendix 5: SAE listing table (PDF, 111KB)

Appendix 6: SAE review process flowchart (PDF, 120KB)

Appendix 7: Serious Adverse Events Cover Sheet (Word, 33KB)

S-1009 (1): SAE reporting form A CTIMP (Word, 59KB)

S-1009 (2): SAE guidelines form A (PDF, 182KB)

S-1009 (3): SAE reporting form B non-CTIMP (Word,546KB)

S-1009 (4): SAE guidelines form B (PDF, 170KB)

S-1009 (5): SAE Narrative continuation sheet (Word, 32KB)

S-1009 (6): SAE Additional drug sheet (Word, 39KB)


Delegation of Responsibilities (PDF, 135KB)

Appendix 1: Chief Investigator Roles and Responsibilities (PDF, 122KB)

Appendix 2: Delegation of Authority and Signature Log (PDF, 207KB)


Site initiation for research sponsored by University of Leicester (PDF, 167KB)

Appendix 1: CTIMP SIV report (Word, 61KB)

Appendix 2: Pharmacy SIV report(Word, 49KB)

Appendix 3: Obsolete

Appendix 4: SIV Visit log (PDF, 105KB)

Appendix 5: Screening Log (PDF, 217KB)

Appendix 6: Enrolment Log (PDF, 152KB)

Appendix 7: Non-CTIMP SIV report (Word, 58KB)

Appendix 8:Obsolete

Appendix 9: Participant screening and enrolment log (PDF, 152KB)

Appendix 10: SIV Outstanding Actions Log (Word, 38KB)


Management and production of corrective and preventative action plan (CAPA) (PDF, 113KB)

Appendix 1: CAPA template (PDF, 170KB)


Identifying and reporting deviations and serious breaches of GCP and/or the protocol for trials (PDF, 128KB)

Appendix 1: Serious breach notification form (Word, 35KB)

Appendix 2: Protocol deviation tracking log (Word, 37KB)

Appendix 3: File note template (Word, 168KB)

Appendix 4: File Note Tracking Log (Word, 32KB)

Appendix 5: Note to File Template (Word, 38KB)


Development safety update report for clinical trials of investigational medicinal product studies (PDF, 165KB)

Appendix 1: DSUR template (Word, 54KB) 


Management of essential documents and trial filing (PDF, 330KB)

Appendix 1: Obsolete

Appendix 2: Obsolete

Appendix 3: Version control tracker (Word, 31KB)

Appendix 3b: Version control and site tracker (Excell, 80KB)

Appendix 4: CTIMP Single Site TMF Contents List (PDF, 311KB)

Appendix 5: CTIMP Multi-site or Coordinating Centre TMF Contents List (PDF, 25KB)

Appendix 6: CTIMP Site Specific File Contents List (PDF, 275KB)

Appendix 7: CTIMP ISF Contents List (PDF, 300KB)

Appendix 8: non CTIMP Single Site TMF Contents List (PDF, 304KB)

Appendix 9: non CTIMP Multi-site or Coordinating Centre TMF Contents List (PDF, 288KB)

Appendix 10: non CTIMP Site Specific File Contents List (PDF, 272KB)

Appendix 11: non CTIMP ISF Contents List (PDF, 298KB)

Appendix 12: PIC Site Tracker (Excell, 12KB)

Appendix 13: Personnel Tracking Log (Excell, 13KB)

Procedure in the event of non-compliance in research (PDF, 210KB)

Process for application for indemnity (PDF, 135KB)

Appendix 1: Indemnity flowchart (PDF, 312KB)


Process for sponsor approval of amendments or additions to documents (PDF, 129KB)

Appendix 1: Amendment Sponsor Green Light Checklist (PDF, 226KB)

Appendix 2: How to Complete the Amendment Tool Guidance (PDF, 192KB)


Training for Staff engaged in research (PDF, 167KB)

Appendix 1: Obsolete 

Appendix 2 - Researcher training and SOP read log (PDF, 162KB)


Informed Consent for research (PDF, 204KB)

Appendix 1:Obsolete

Appendix 2: Assent and authority signature log (Word, 31KB)

Appendix 3: Assent consent log (Word, 34KB)

Appendix 4: Pre-consent activity proforma (Word, 37KB)

Appendix 5: Obsolete

Appendix 6: Obsolete

Appendix 7: Consent and eligibility medical note annotation example (PDF, 149KB)

Process for Submission of Annual Progress Reports (PDF, 124KB)

Investigator’s brochure preparation, review and approval (PDF, 134KB)

Appendix 1: Contents template (PDF, 106KB)

Appendix 2: Review template (Word, 57KB)


Study Close down and end of study reporting (PDF, 152KB)

Appendix 1: Site closedown checklist CTIMP studies (PDF, 657KB)

Appendix 2: Site closeout visit log (Word, 43KB)

Appendix 3: Site closeout checklist non-CTIMP studies (PDF, 152)


Sponsor green light process (PDF, 143KB)

Appendix 2: Sponsor green light checklist (PDF, 192KB)

Process for writing protocols (PDF, 142KB)

Convening a data safety monitoring committee (PDF, 138 KB)

Appendix 1: Data safety monitoring charter (PDF, 524KB)


Urgent safety measures for studies (PDF, 142KB)

Appendix 1: Urgent safety measure template (PDF, 666KB)

Creating a statistical analysis plan (SAP) (PDF, 117KB)
S-1031 Managing amendments to contracts (PDF, 120KB) 

Archiving of essential documents for research studies (PDF, 164KB)

Appendix 1: Archiving facility checklist (PDF, 85KB)

Appendix 2: Archiving electronic aspects of the trial master file  (PDF, 293KB)

Appendix 3: Pre archiving checklist (Word, 24KB)

Appendix 4: Archiving process flowchart (PDF, 269KB)

Appendix 5: Retrieval process flowchart (PDF, 367KB)

Form A (PDF, 533KB)

Form B (PDF, 712KB)

Form C (PDF, 473KB)


Process for assessing site feasibility (PDF, 139KB)

Appendix 1: Site feasibility assessment (Word, 79KB)

Appendix 2: Site feasibility assessment pharmacy (Word, 33KB)


Inclusion of incapacitated adults in research studies (PDF, 135KB)

Appendix 1:Obsolete

Appendix 2: Incapacitated adults nomination form (PDF, 516KB)

Randomisation and blinding for research studies (PDF, 187KB)
Data management process for research (PDF, 239KB)
Vendor selection and oversight for research studies (PDF, 119KB)
End of study reporting requirements for research studies (PDF, 234KB)

Case report form production for research studies (PDF, 194KB)

Appendix 1: Case report form template (PDF, 1516KB)

Appendix 2: A guide to designing a case report form (PDF, 638KB)


Finance process for research studies (PDF, 174KB)

Appendix 1: Sponsor finance NHS research costs form (PDF, 11KB)


Management of healthy volunteers in research studies of the bioequivalence, pharmacokinetics (PK) or pharmacodynamics (PD) of investigational medicinal products (PDF, 165KB)

Appendix 1: TOPs consent template (Word, 29KB) 


Sample management in research (PDF, 144KB) 

Appendix 1a: Fridge temperature log (PDF, 442KB) 

Appendix 1b: Freezer temperature log (PDF, 439KB) 

Appendix 1c: Nitrogen log (PDF, 144KB)

Appendix 2: Sample tracking log (PDF, 129KB) 

Appendix 3: Sample end of study form (PDF, 711KB) 

Appendix 4: Shipping instructions for biological samples (PDF, 614KB) 


Medical device Studies safety reporting (requiring MHRA approval) (PDF, 217KB)

Appendix 1: Event categorisation flowchart (PDF, 424KB) 

Appendix 2: Adverse event adverse effect record (Word, 29KB) 

Appendix 3: Serious adverse event reporting form C (Device) (Word, 140KB)

Appendix 4: SAE guidelines form C (PDF, 512KB) 

Appendix 5: MHRA device reporting form (Excel, 29KB) 

Appendix 6: Medical device Sponsor process flowchart (PDF, 117KB) 

Appendix 7: Obsolete

Process for quality assurance (PDF, 137KB)

End of Sponsor Green Light Process (PDF, 122KB)

Appendix 1: End of Sponsor Green Light Checklist (Word, 56KB)

Pandemic Research (PDF, 576KB)

Versions of Standard Operating Procedures (SOPs) used throughout the duration of a study/trial need to be maintained. For University of Leicester Sponsored studies we recommend that in place of printing all the SOPs relating to your study, a 'Note to File' signposting the location of the relevant Sponsor SOP is added to the SOP section of your Trial Master File (TMF) or Investigator Site File (ISF). A copy of the Note to File is available below
Note to File regarding SOP location (PDF, 113kb)

The definitive list of SOPs, including their versions and effective dates is maintained by the Sponsor and is available upon request, please email rgosponsor@le.ac.uk.  
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