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 Process for Writing Standard Operating Procedures (SOPs) for Research Governance Procedures for Research  
S-1002

Initial Documentation Review Process)

S-1003 Sponsor Risk Assessment and Management of Research 
S-1005 Sponsor Contracts Management 
S-1006 Ensure NHS permission is received by CI for use when University of Leicester (UoL) are sponsor 
S-1007 Site Management (Monitoring) for University of Leicester when Acting as Sponsor
S-1009 Processing and Reporting of Serious Adverse Events, Serious Adverse Reactions and Suspected Unexpected Serious Adverse Reactions 
S-1010 Chief Investigator Responsibilities 
S-1011 Site Initiation for Research Sponsored by University of Leicester (UoL)
S-1012 Management and Production of Corrective And Preventative Action plan (CAPA) 
S-1013 Identifying and Reporting Deviations and Serious Breaches of GCP and/or the Protocol for Trials 
S-1014 Development Safety Update Report for Clinical Trials of Investigational Medicinal Product Studies
S-1015 Management of Essential Documents and Trial Filing 
S-1016 Procedure in the Event of Non-Compliance in Research
S-1017 Process for Application for Indemnity
S-1018 Process for Sponsor Approval of Amendments or Additions to Documents 
S-1020 Training for Staff Engaged in Research
S-1021 Informed Consent for Research
S-1022 Process for Submission of Annual Progress Reports 
S-1023 Investigator’s Brochure Preparation, Review and Approval
S-1024 Study Close down and End of Study Reporting
S-1025 Sponsor Green Light Process
S-1026 Sponsor Green Light Process for Amendments to Research
S-1027 Process for Writing Protocols
S-1028 Convening a Data Safety Monitoring Committee
S-1029 Urgent Safety Measures for Studies
S-1030 Creating a Statistical Analysis Plan (SAP)
S-1031 Managing Amendments to Contracts
S-1032 Archiving of Essential Documents for Research Studies
S-1033 Process for Assessing Site Feasibility
S-1034 Inclusion of Incapacitated Adults in Research Studies
S-1035 Randomisation and Blinding for Research Studies
S-1036 Data Management Process for Research
S-1037 Vendor Selection and Oversight for Research Studies
S-1038 End of Study Reporting Requirements for Research Studies
S-1039 Case Report Form Production for Research Studies
S-1040 Finance Process for Research Studies
S-1041 Management of Healthy Volunteers in Research Studies of the Bioequivalence, Pharmacokinetics (PK) or Pharmacodynamics (PD) of Investigational Medicinal Products
S-1042 Sample Management in Research 
S-1043 Medical Device Studies Safety Reporting (Requiring MHRA approval) 
S-1044 Process for Quality Assurance

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 Non-CTIMP Line Listing

Appendix 3 SAE Listing Table

Appendix 4 SAE Review Process Flowchart

Appendix 5 Template Sponsor SAE Email

Appendix 6 Multicentre CTIMP Line Listing

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

 

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

S-1043 Medical Device Studies Safety Reporting

Appendix 1 Event Categorisation Flow Chart

Appendix 2 Adverse event Adverse Effect record

Appendix 3 SAE Report Form C

Appendix 4 SAE Form C Completion Guidance Document

Appendix 5 MHRA Device Reporting Form

Appendix 6 Medical Device Sponsor Process Flowchart

Appendix 7 Template  SAE SADE Follow Up Information Request   Email

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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