Research Standard Operating Procedures (SOPs)

Quality Assurance

Standard Operating Procedures for Quality Assurance

QA1 Preparation, Approval and Review of SOPs and WIs v7.0 OCT2023.pdf [pdf] 600KB

QA2 Monitoring v4.0 MAR2024.pdf [pdf] 697KB

QA3 Audit v9.0 DEC2024.pdf [pdf] 340KB

QA4 Suspension or Termination of UHP Sponsored Studies v8.0 OCT2024.pdf [pdf] 321KB

QA5 Preparation for a Good Clinical Practice Inspection v4.0 OCT2024.pdf [pdf] 319KB

QA6 Suspected research fraud.pdf [pdf] 169KB

QA7 Risk Assessment of Research Studies v1.0 DEC2024.pdf [pdf] 333KB

Templates

Template for Standard Operating Procedure (SOP) [docx] 87KB

Template for Work Instruction (WI) [docx] 88KB

Pre-Study

Standard Operating Procedures for Pre-Study

P1 Feasibility and Site Selection v3.0 JUN2024.pdf [pdf] 809KB

P2_Trust Sponsorship of studies.pdf [pdf] 229KB

P3 Gaining and maintaining authorisations to conduct research v8.0 AUG2024.pdf [pdf] 353KB

P4 Registering Clinical Trials on Public Access Databases v2.0 APR2024.pdf [pdf] 612KB

P5_ Investigator Brochure.pdf [pdf] 193KB

P6_Risk Assessment.pdf [pdf] 281KB

P7 Use of Human Tissue in Research v3.0 JAN2025.pdf [pdf] 414KB

P8 Document and Version Control v4.0 MAY2024.pdf [pdf] 941KB

P9_Trial Master File & Investigator Site File.pdf [pdf] 326KB

P10 Delegation of Duties v. 5.2 AUG 2023.pdf [pdf] 363KB

P11 Research Passport v3.0 SEP2024.pdf [pdf] 305KB

P12_Gaining permission for research involving medical exposures (using Ionising Radiations).pdf [pdf] 402KB

P13_Database management, security, design and validation.pdf [pdf] 252KB

P14 Validation of Computerised Systems for Research v3.0 OCT2024.pdf [pdf] 260KB

P15 Designing Case Report Forms v3.0 JUL2024.pdf [pdf] 920KB

P16_Data Management & Independent Data Monitoring Committee.pdf [pdf] 161KB

P17 Statistical Analysis Plans v3.0 18Oct2024.pdf [pdf] 938KB

P18_Randomisation & Blinding.pdf [pdf] 183KB

P19_Access and use of REDCap Community.pdf [pdf] 191KB

P20 - Preparation and Maintenance of an ISF v2.0 JAN2025.pdf [pdf] 344KB

P21 Research Recruitment Register v1.0 JUN2024.pdf [pdf] 499KB

P23 Data Protection in Research Studies v1.0 OCT2024.pdf [pdf] 435KB

Template

ISF Contents List Template 2022.docx [docx] 100KB

Trial Operation

Standard Operating Procedures for Trial Operation

T1 Study Start Up v2.0 AUG2024.pdf [pdf] 468KB

T2 Identification and Approach of Potential Participants v3.0 JUN2024.pdf [pdf] 324KB

T3 Consent for entry into a clinical research study v 7.1 SEP2023.pdf [pdf] 661KB

T4_Case Report Form (CRF) completion.pdf [pdf] 157KB

T5 Safety Reporting v9.0 OCT2024.pdf [pdf] 373KB

T6 Non Compliance Reporting v5.0 NOV2024.pdf [pdf] 378KB

T7 Urgent Safety Measures v4.0 JUL2024.pdf [pdf] 339KB

T8 Amendments v6.0 AUG2024.pdf [pdf] 314KB

T9 Preparation and Submission of Periodic Reports v.6.0 AUG2024.pdf [pdf] 576KB

T10_Recording of study data.pdf [pdf] 408KB

T11 Provision of Information about Virology Tests and Results to Clinical Research Volunteers_.pdf [pdf] 238KB

T12_Researcher Audit Guidance.pdf [pdf] 287KB

T13_Consistency of images for clinical research.pdf [pdf] 132KB

T15 Safety Reporting for UHP Hosted Studies v1.0 JUN2024.pdf [pdf] 851KB

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