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University of Leicester Sponsor Standard Operating Procedures

SOP reference number

SOP title 
S-1000
 Process for writing standard operating procedures (SOPs) for Research Governance Procedures for research (PDF, 66KB)
S-1002

Sponsor Review process (PDF, 189KB)

Appendix 1a: Obsolete

Appendix 1b: Obsolete

Appendix 2: Sponsor Peer Review Form (Word, 34KB)
S-1003

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)
S-1006
 Agreements, Approvals and Contracts (PDF, 184KB)
S-1007

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)
S-1009

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)
S-1010

Delegation of Responsibilities (PDF, 135KB)

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

Appendix 2: Delegation of Authority and Signature Log (PDF, 207KB)
S-1011

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)
S-1012

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

Appendix 1: CAPA template (Word, 43KB)
S-1013

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)
S-1014

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

Appendix 1: DSUR template (Word, 54KB) 
S-1015

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)
S-1016
 Procedure in the event of non-compliance in research (PDF, 210KB)
S-1017

Process for application for indemnity (PDF, 135KB)

Appendix 1: Indemnity flowchart (PDF, 312KB)
S-1018

Process for sponsor review and approval of amendments (PDF, 129KB)

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

Appendix 2: How to Complete the Amendment Tool Guidance (PDF, 192KB)
S-1020

Qualification and Training for Staff engaged in research (PDF, 174KB)

Appendix 1: Obsolete 

Appendix 2 - Researcher training log (PDF, 132KB)

Appendix 3 - SOP Read Log (Word, 36KB)
S-1021

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)
S-1022
 Process for Submission of Progress Reports (PDF, 124KB)
S-1023

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

Appendix 1: Contents template (PDF, 106KB)

Appendix 2: Review template (Word, 57KB)
S-1024

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)
S-1025

Sponsor green light process (PDF, 143KB)

Appendix 2: Sponsor green light checklist (PDF, 192KB)
S-1027
 Process for writing protocols (PDF, 142KB)
S-1028

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

Appendix 1: Data safety monitoring committee charter (Word, 79KB)

Appendix 2: Data safety monitoring committee charter signature page (Word, 34KB) 

Appendix 3: Data monitoring committee charter conflicts of interest (Word, 33KB)
S-1029

Urgent safety measures for studies (PDF, 142KB)

Appendix 1: Urgent safety measure template (PDF, 666KB)
S-1030
 Creating a statistical analysis plan (SAP) (PDF, 117KB)
S-1032

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)
S-1033

Process for assessing site feasibility (PDF, 135KB)

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

Appendix 2: Site feasibility assessment pharmacy (Word, 47KB)
S-1034

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

Appendix 1:Obsolete

Appendix 2: Incapacitated adults nomination form (PDF, 516KB)
S-1035
 Randomisation and blinding for research studies (PDF, 187KB)
S-1036
 Data management process for research (PDF, 239KB)
S-1037
 Vendor selection and oversight for research studies (PDF, 119KB)
S-1039

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
S-1040

Finance process for research studies (PDF, 174KB)

Appendix 1: Sponsor finance NHS research costs form (PDF, 11KB)
S-1041

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) 
S-1042

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) 
S-1043

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
S-1044
 Process for quality assurance (PDF, 137KB)
S-1050

Pandemic Research (PDF, 215KB)

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

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

University Hospitals of Leicester Standard operating procedures

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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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