Standard Operating Procedures

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
S-1050
Pandemic Research

View all SOP Appendices