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

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 004 Research Passports

SOP 005 Grant Applications

SOP 205 Adverse Events: Identifying, Recording and Reporting for CTIMPs Sponsored by the NNUH

SOP 205 App 1 CTIMPS SAE Form

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 331 – Remote Monitoring

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 405 Obtaining and Maintaining Medicines and Healthcare Products Regulatory Agency (MHRA) Approval for a Clinical Trial

SOP 410 Set up and initiation of an Investigator Site

SOP 410 Appendix 1 Site Initiation Check List

SOP 410 Appendix 2 Site Initiation Agenda Template

SOP 505 Training Requirements and Creating and Maintaining Training Records

SOP 505a SOP Training Matrix

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 Approval 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 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 Appendices

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 (