Research Governance Sponsorship Standard Operating Procedures (SOPs)

SOP reference number

SOP title 

Process for Creating, Reviewing, Approving and Publishing Standard Operating Procedures (SOPs) (PDF, 129KB)

Appendix 1 - SOP Template (PDF, 97KB)

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)

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 safety events for trials (PDF, 211KB)

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

Appendix 7: Serious Adverse Event Cover Sheet (Word, 37KB)

Appendix 8 - Serious Adverse Events Cover Sheet and SAE Reporting Form (Word, 68KB)

Appendix 9 - SAE Reporting Form (Word, 64KB)

Appendix 10 - SAE Reporting Form Guidance (PDF, 236KB)

Appendix 11 - Additional Drug Sheet (Word, 38KB)

Appendix 12 - Narrative continuation sheet (Word, 35KB)

Appendix 13 - SAE Listing (Word, 31KB)

Appendix 2-6 = Obsolete

Delegation of Activities (PDF, 135KB)

Appendix 1: Chief Investigator Roles and Responsibilities (PDF, 141KB)

Appendix 2: Research Location Delegation of Activities Log (PDF, 182KB)

Appendix 3: Central Trial Management Delegation of Activities Log (PDF, 179KB)

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 (Word, 43KB)

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 (DSUR) for Clinical Trials of Investigational Medicinal Products (PDF, 148KB)

Appendix 1: DSUR template (Word, 53KB) 

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)

Insurance and Indemnity Arrangements (PDF, 217KB)

Appendix 1: Obsolete

Process for sponsor review and approval of modifications (PDF, 217KB)

Appendix 1 and 2: Obsolete

Qualification and Training for Staff engaged in Trials (PDF, 187KB)

Appendix 2: Researcher training log (PDF, 37KB)

Appendix 3: SOP Read Log (Word, 35KB)

Appendix 4: Investigator Training (Excel, 20KB)

Appendix 1: Obsolete 

Informed Consent (PDF, 213KB)

Appendix 4: Pre-consent fasting (Word, 43KB)

Appendix 7: Consent and eligibility annotation template example (Word, 40KB)

Appendix 1, 2, 3, 5, and 6: Obsolete

Preparation and Management of the Investigator's Brochure (IB) (PDF, 129KB)

Appendix 1: Contents template (Word, 52KB)

Appendix 2: SmPC and IB Review template (Word, 47KB)

End of study activity(Declaration, Notification and Reporting) (PDF, 154KB)

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 (PDF, 125KB)

Appendix 1 and 2:Obsolete

Convening a Data Safety Monitoring Committee (PDF, 138 KB)

Appendix 1: Data Safety Monitoring Committee Charter (Word, 79KB)

Appendix 4: Trial Steering Committee Charter (Word, 75KB)

Appendix 2 and 4: Obsolete

Urgent Safety Measures for Trials (PDF, 139KB)

Appendix 1: Urgent safety measure template (Word, 42KB)

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, 135KB)

Appendix 1: Site feasibility assessment (Word, 121KB)

Appendix 2: Site feasibility assessment pharmacy (Word, 47KB)

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

Appendix 1:Obsolete

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

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

Appendix 1a: Case report form template (Word, 61KB)

Appendix 1b: Concomitant Medications Log (Word, 37KB)

Appendix 1c: Adverse Event Log (Word, 37KB)

Appendix 2: Obsolete

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, 199KB) 

Appendix 1a: Fridge temperature log (Word, 123KB) 

Appendix 1b: Freezer temperature log (Word, 123KB) 

Appendix 1c: Nitrogen log (Word, 142KB)

Appendix 2: Obsolete

Appendix 3: Obsolete

Appendix 4: Shipping instructions for biological samples (PDF, 280KB) 

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

Pandemic Research (PDF, 215KB)

Appendix 1:Pandemic Research Risk Assessment Form (Word, 77KB)

Appendix 2: Pandemic Site File Note (Word, 52KB)