This section lists the Standard Operating Procedures (SOPs) which apply to all healthcare research within the Trust and the UEA as agreed in the NNUH-UEA Joint Research Governance Policy.
If you have queries about the use of these SOPs, or would like to provide feedback please contact the R&D Office on 01603 289808 or rdoffice@nnuh.nhs.uk.
All Research Staff should complete the most current SOP Matrix and place a copy in their Training Files. The training matrix is available on TrustDocs ID 14992.
SOP 001 Production, Review Approval and Control of SOPs Related to Research Activities
SOP 002 Good Clinical Practice (GCP) Training
SOP 003 Research & Development Annual Audit Plan
SOP 205 Adverse Events: Identifying, Recording and Reporting for CTIMPs Sponsored by the NNUH
SOP 206 Adverse Events: Identifying, Recording and Reporting Adverse Events for non CTIMPs
SOP 206 App 1 Non CTIMPS SAE Form
SOP 207 Adverse Events: Identifying, Recording and Reporting Adverse Events for Device Trials
SOP 207 App 1 AE Form for Device Trials
SOP 210 Managing Protocol and Regulatory Non-Compliance including Serious Breaches
SOP 210 App 1 Form for Reporting Serious Breaches / Protocol Non Compliance
SOP 215 Research Study Amendments
SOP 220 – Investigation of allegations of Research Fraud and Misconduct
SOP 230 Urgent Safety Measures
SOP 305 Creating and Maintaining a Trial Master File or Investigators Site File
SOP 310 Development of Participant Information Sheet and Informed Consent Form
SOP 315 Obtaining Written Informed Consent from Competent Adults in Clinical Trials
SOP 316 Distance (Remote) Consenting for Children and Neonates in Research Studies
SOP 317 Obtaining remote consent from competent adults in clinical trials
SOP 318 Standards for email communication in relation to research studies, including research participants and sponsors
SOP 320 Developing a Research Protocol
SOP 325 Study Start up Activities for Clinical Research Trials
SOP 330 Monitoring CTIMPs and Device Trials
SOP 335 Research Project Closure
SOP 340 Clinical Trial Reporting
SOP 345 Identifying Trial Patients on Hospital Admission
SOP 350 Designing and Developing a Case Report Form
SOP 351 Completing a Case Report Form
SOP 355 Establishing Identity of Participants in Clinical Research
SOP 400 Joint Arrangements for Authorisation of Research Sponsorship
SOP 401 Sponsorship Request and Approval for Research Studies and Clinical Trials
SOP 410 Set up and Initiation of an Investigator Site
SOP 410 Appendix 1 Site Initiation Visit checklist
SOP 410 Appendix 2 Agenda template – Site initiation
SOP 411 Sponsor Oversight and Site Initiation for Non-regulated Studies Sponsored by NNUH
SOP 505 Training Requirements and Creating and Maintaining Training Records
SOP 510 Medical Cover for Clinical Research Trials
SOP 600 Creating a Statistical Analysis Plan
SOP 605 Sample Size Calculation
SOP 700 NNUH Vendor Selection and Oversight
SOP 705 Quality Control and Quality Assurance
SOP 710 Good Clinical Practice (GCP) Regulatory Audit or Inspection
SOP 715 Principles of Clinical Research Laboratory Practice
SOP 725 Capacity Capability and Risk Assessment NNUH Hosted Studies
SOP 730 Computer System Validation
SOP 800 Non Study Specific Documentation Management
SOP 805 Clinical Data Management System – CDMS SET-UP
SOP 810 Clinical Data Management System- SPECIFICATION, DEVELOPMENT, TEST AND DEPLOYMENT
SOP 815 Clinical Data Management System: Locking and Unlocking The Database
SOP 820 Clinical Data Management System : MAINTENANCE AND SUPPORT
SOP 825 Clinical Data Management System – Validation
SOP 835 Clinical Data Management System – Emergency Unblinding
SOP 840 Clinical Data Management System – Data Management and Security
SOP 850 Clinical Data Management System – Closedown
SOP 855 Clinical Data Management System – Data Manipulation after Export
SOP 860 MP Clinical Data Management System – Data Request
SOP 865 Study Specific Document Management
SOP 900 – Archiving, retrieval and destruction of Research Documents
SOP 900 Appendix 2 Delivery Team Archiving Checklist
SOP 900 Appendix 3 R&D Inventory Checklist
SOP 900 Appendix 4 Chain of Custody Form
SOP 900 Appendix 6 Request for Archive Retrieval
SOP 900 Appendix 8 R&D Archive Process Map
Pharmacy Related SOP’s For copies of the Pharmacy SOP’s please contact Gail Healey (gail.healey@nnuh.nhs.uk)