Standard Operational Procedures and Related Forms

The following Standard Operating Procedures and forms apply to all projects sponsored by The University of Leicester, and all such projects must adhere to the procedures detailed therein. Please refer to this page often as the most up-to-date version of each SOP will appear on this page.

All SOPs on this webpage are controlled documents.

SOP Reference Number

 

SOP Title

S-1000 UoL Process for Writing Standard Operating Procedures (SOPs) for Research Governance Procedures for Research Sponsored by the  University of Leicester (UoL) (SOP for SOPs)  April 2017
S-1002 UoL

Initial Documentation Review Process for Research sponsored by University of Leicester (UoL) April 2017

S-1003 UoL Sponsor Risk Assessment and Management of Research sponsored by University of Leicester (UoL) April 2017
S-1005 UoL Sponsor Contracts Management for Research sponsored by University of Leicester (UoL) April 2017
S-1006 UoL Ensure NHS permission is received by CI for use when University of Leicester (UoL) are sponsor April 2017
S-1007 UoL Site Management (Monitoring) for University of Leicester when Acting as Sponsor April 2017
S-1009 UoL Processing and Reporting of Serious Adverse Events, Serious Adverse Reactions and Suspected Unexpected Serious Adverse Reactions for all Research sponsored by University of Leicester (UoL) April 2017
S-1010 UoL Chief Investigator Responsibilities for Research Sponsored by University of Leicester (UoL) April 2017
S-1011 UoL Site Initiation for Research Sponsored by University of Leicester (UoL) April 2017
S-1012 UoL Management and Production of Corrective And Preventative Action plan (CAPA) for Studies Sponsored by University of Leicester (UoL) April 2017
S-1013 UoL Identifying and Reporting Deviations and Serious Breaches of GCP and/or the Protocol for Trials Sponsored by the University of Leicester (UoL) April 2017
S-1014 UoL Development Safety Update Report for Clinical Trials of Investigational Medicinal Product Studies Sponsored by University of Leicester (UoL) April 2017
S-1015 UoL Management of Essential Documents and Trial Filing for Research Sponsored by the University of Leicester April 2017
S-1016 UoL Procedure in the Event of Non-Compliance in Research sponsored by University of Leicester UoL April 2017
S-1017 UoL Process for Application for Indemnity for Studies sponsored by University of Leicester (UoL) June 2016
S-1018 UoL Process for Sponsor Approval of Amendments or Additions to Documents for Studies already sponsored by University of Leicester (UoL) April 2017
S-1020 UoL Training for Staff Engaged in Research Sponsored by the University of Leicester April 2017
S-1021 UoL Informed Consent for Research Sponsored by the University of Leicester April 2017
S-1022 UoL Process for Submission of Annual Progress Reports for Research sponsored by University of Leicester (UoL) April 2017
S-1023 UoL Investigator’s Brochure Preparation, Review and Approval for Research  Sponsored by the University of Leicester April 2017
S-1024 UoL Study Closedown and End of Study Reporting for Research Sponsored by the University of Leicester April 2017
S-1025 UoL Sponsor Green Light Process for Research Sponsored by the University of Leicester (UoL) April 2017
S-1026 UoL Sponsor Green Light Process for Amendments to Research Sponsored by the University of Leicester (UoL) April 2017
S-1027 UoL Process for Writing Protocols for Research Sponsored by the University of Leicester (UoL) April 2017
S-1028 UoL Convening a Data Safety Monitoring Committee for Research Sponsored by the University of Leicester (UoL) April 2017
S-1029 UoL Urgent Safety Measures for Studies Sponsored by University of Leicester (UoL) April 2017
S-1030 UoL Creating a Statistical Analysis Plan (SAP) for Research Sponsored by the University of Leicester (UoL) April 2017
S-1031 UoL Managing Amendments to Contracts for Research Sponsored by University of Leicester April 2017
S-1032 UoL Archiving of Essential Documents for Research Studies Sponsored by the University of Leicester April 2017
S-1033 UoL Process for Assessing Site Feasibility for Research Sponsored by University of Leicester April 2017
S-1034 UoL Inclusion of Incapacitated Adults in Research Studies Sponsored by the University of Leicester April 2017
S-1035 UoL Randomisation and Blinding for Research Studies Sponsored by the University of Leicester April 2017
S-1036 UoL Data Management Process for Research Sponsored by University of Leicester April 2017
S-1037 UoL Vendor Selection and Oversight for Research Studies Sponsored by the University of Leicester April 2017
S-1038 UoL End of Study Reporting Requirements for Research Studies Sponsored by the University of Leicester April 2017
S-1039 UoL Case Report Form Production for Research Studies Sponsored by University of Leicester April 2017
S-1040 UoL Finance Process for Research Studies Sponsored by University of Leicester May 2016
S-1041 UoL Management of Healthy Volunteers in Research Studies of the Bioequivalence, Pharmacokinetics (PK) or Pharmacodynamics (PD) of Investigational Medicinal Products Sponsored by the University of Leicester April 2017
S-1042 UoL Sample Management in Research May 2017

Appendices

SOP Reference Number & Title

Appendix Title                                                                                                       

S-1002 UoL Initial Documentation Review Process

Appendix 1 Sponsorship Application Form

Appendix 2 Sponsor Peer Review Form

S-1003 Sponsor Risk Assessment and Management of Research

Appendix 1 Risk Assessment Form

Appendix 2 Sponsor Review Risk Assessed Studies

Appendix 3 Sponsor Review Non-risk Assessed Studies

Appendix 4 Risk Assessment Flow Chart

S-1007 Site Management (Monitoring) for University of Leicester when Acting as Sponsor

Appendix 1 Monitoring Plan Template

Appendix 2 Monitoring Strategy Table

Appendix 3 Trial Monitoring Visit Log

Appendix 4 Template Source Data Agreement

Appendix 5 Monitoring Visit Report & Response Document

Appendix 6 Contact Monitoring Log

Appendix 7 Non-CTIMP Interim Site Audit checklist & Response

S-1009 Processing and Reporting of Serious Adverse Events, Serious Adverse Reactions and Suspected Unexpected Serious Adverse Reactions

Appendix 1 Pregnancy Reporting Form

Appendix 2 Multicentre Line Listing

Appendix 3 SAE Listing Table

Appendix 4 SAE Review Process Flowchart

Appendix 5 Template Sponsor SAE Email

SAE Reporting Form A CTIMP

SAE Guidelines Form A

SAE Reporting Form B Non-CTIMP

SAE Guidelines Form B

S-1010 Chief Investigator Responsibilities Appendix 1 UoL Roles and Reponsibilities of CI Agreement
S-1011 Site Initiation for Clinical Trials of Investigational Medicinal Products Research

Appendix 1 Site Initiation Checklist & Outstanding Issues

Appendix 2 Pharmacy Site Initiation Visit Checklist & Outstanding Issues

Appendix 3 SOP Read Log

Appendix 4 Site Initiation Visit Log

Appendix 5 Screening Log

Appendix 6 Subject Enrolment Log

Appendix 7 Non-CTIMP Site Initiation Checklist

Non CTIMP SIV Checklist Guidance Document

S-1012 Management and Production of Corrective And Preventative Action plan (CAPA) for Studies

Appendix 1 CAPA form

Appendix 2 CAPA Tracking Log

S-1013 Identifying and Reporting Deviations and Serious Breaches of GCP and/or the Protocol for Trials

Appendix 1 Serious Breach Notification Form

Appendix 2 Protocol Deviation Tracking Log

 

S-1014 Development Safety Update Report for Clinical Trials of Investigational Medicinal Product Studies

Appendix 1 DSUR Template

Appendix 2 DSUR Reporting Timeframe Working Illustration

Appendix 3 DSUR Reporting Timeframe Working Instructions

 

S-1015 Creating & Maintaining a Trial Master file (TMF) or Investigator Site File (ISF)

Appendix 1 TMF/ISF Contents CTIMP

Appendix 2 TMF/ISF Contents Non-CTIMP

Appendix 3 Version Control Tracker

S-1017 Process for Application for Indemnity Appendix 1- Indemnity Flowchart
S-1020 Training for Staff Engaged in Research Appendix 1 Protocol Training Log
S-1021 Informed Consent

Appendix 1 Delegation of Authority & Signature Log

Appendix 2 Assent Authority & Signature Log

Appendix 3 Assent Consent Log

 

S-1023 Investigator’s Brochure Preparation, Review and Approval

Appendix 1 IB Contents Template

Appendix 2 IB Review Template

S-1024 Study Closedown and End of Study Reporting

Appendix 1 Site Closedown Checklist CTIMP Studies

Appendix 2 UoL Site Close Down Visit Log

Appendix 3 Site Closedown Checklist non-CTiMP Studies

S-1025 Sponsor Green Light Process

Appendix 1 Sponsor Green Light Review Process Flowchart

Appendix 2 Sponsor Green Light - Green Light Process First Site

Appendix 3 Sponsor Green Light - Multi Centre Site Sponsor Green Light

Appendix 4 Sponsor Green Light Contracts - Agreements Listings

S-1026 Sponsor Green Light Process

Appendix 1 Amendments for MHRA

Appendix 2 Amendments for MHRA & REC

Appendix 3 Amendments for REC

Appendix 4 Amendments not requiring notification

Appendix 5  Multi Centre Site Sponsor Green Light

Appendix 6 Green Light Process First Site

S-1027 Process for Writing Study Protocols

HRA Non-CTiMP Clinical Trial Protocol (Qualitative)

UoL Non-CTiMP Clinical Trial Protocol

HRA CTiMP Clinical Trial Protocol

S-1028 Convening a Data Safety Monitoring Committee Appendix 1 Data Safety Monitoring Committee Charter
S-1029 Urgent Safety Measures Appendix 1 Urgent Safety Measures Template
S-1032 Archiving of Essential Documents -

Appendix 1 Archiving Facility Checklist

Appendix 2 Archiving Electronic Aspects of  TMF

Appendix 3 Archive Process Checklist

Appendix 4 Archiving process flowchart

Appendix 5  Retrieval process flowchart

Form A

Form B

Form C

S-1033 Process for Assessing Site Feasibility

Appendix 1 Site Feasibility Assessment

Appendix 2 Site Feasibility Assessment Pharmacy

S-1034 Inclusion of Incapacitated Adults in Research Studies

Appendix 1 Conditions & Principles which apply Inclusion of an Incapacitated Adult

Appendix 2 S-1034 Incapacitated Adults Nomination Form

S1039 Case Report Form Production

Appendix 1 Case Report Form Template

Appendix 2 Guide to designing a CRF

S-1040 Finance Process Appendix 1 Finance Process
S-1041 Management of Healthy Volunteers in Research Studies of the Bioequivalence, Pharmacokinetics (PK) or Pharmacodynamics (PD) of Investigational Medicinal Products Appendix 1 TOPS Consent Template
S-1042 Process for Sample Management

Appendix 1a  FRIDGE Temperature  Log

Appendix 1b FREEZER  Temperature Log

Appendix 1c NITROGEN  Log

Appendix 2 Sample Tracking Log

Appendix 3 Sample End of Study Sponsor Form

Appendix 4 Shipping Instructions for Biological Samples

Related Forms

Serious Adverse Event Reporting Form A for CTIMP (Word)

Serious Adverse Event Reporting Form A for CTIMP Guidelines

Serious Adverse Event Reporting Form B for Non-CTIMP (Word)

Serious Adverse Event Reporting Form B for Non-CTIMP Guidelines

Pregnancy Reporting Form (Word)

Trial Master File Note (Word)

 

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Contact details
Research Governance Office
Research & Enterprise Division
University of Leicester
Fielding Johnson Building
University Road
Leicester, LE1 7RH
0116 373 6410/223 1660
uolsponsor@leicester.ac.uk

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