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The Research Ethics, Governance and Integrity Office
Standard Operating Procedures

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