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 SOP’s, or would like to provide feedback please contact the R&D Office on 01603 289808 or

There is an e-learning module for the Standard Operating Procedures on the NNUH TMS. This can found under  ‘Courses; Full Course List; Miscellaneous; Research & Development SOP training’. You will need a username and password to access the module. It is recommended that you use the Chrome browser as there are known issues when using Internet Explorer.

All Research Staff should complete the most current SOP Matrix and place a copy in their Training Files. Please request a copy of the most recent SOP matrix by contacting the R&D Office on

SOP Reference Title Document
SOP 001 Production, Review Approval and Control of SOPs Related to Research Activities  SOP 001 v1.5
SOP 205 Adverse Events: Identifying, Recording and Reporting for CTIMPs Sponsored by the NNUH  SOP 205 v2.4
SOP 206 Identifying, Recording and Reporting Adverse Events for Healthcare Research Studies that are not CTIMPS  SOP 206 v1.1
  Serious Adverse Events Report Form  SAE form V1.4
SOP 210 Managing Protocol and Regulatory Non-Compliance including Serious Breaches SOP 2.10 v4.0
  Form for Protocol Deviation, Violation, Breach or Serious Breach of Protocol or GCP – Please contact R&D Office for a copy Protocol Deviation Form v1.1
SOP 215 Research Study Amendments  SOP 215 v1.0
SOP 220 Fraud and Misconduct  SOP 220 v1.4
SOP 230 Urgent Safety Measures   SOP 230 v2.2
SOP 305 Creating and Maintaining a Trial Master File  SOP 305 v1.6
SOP 310 Development of Participant Information Sheet and Informed Consent Form  SOP 310 v1.4
SOP 315 Obtaining Written Informed Consent from Competent Adults in Clinical Trials   SOP 315 v1.6
SOP 320 Developing a Research Protocol  – Please contact R&D Office for a copy  SOP 320 v2.2
SOP 325 Study Start up Activities for Clinical Research Trials  SOP 325 v1.5
SOP 330 Monitoring CTIMPs and Device Trials  SOP 330 v1.5
SOP 335 Research Project Closure (including procedure for project suspension or early termination)  SOP 335 v1.4
SOP 340 Clinical Trial Reporting  SOP 340 v1.3
SOP 345 Identifying Trial Patients on Hospital Admission  SOP 345 v1.3
 SOP 350 Designing and Developing a Case Report Form SOP 350 v 1.1
SOP 351 Completing a Case Report Form SOP 351 v1.1
SOP 355 Establishing Identity of Participants SOP 355 v1.0
SOP 400 Joint Arrangements for Research Authorisation of Research Sponsorship  SOP 400 v1.5
SOP 405 Obtaining and Maintaining Medicines and Healthcare Products Regulatory Agency (MHRA) Approval for a Clinical Trial SOP 405 v1.5
 SOP 410 Set up and initiation of an Investigator Site  SOP 410 v1.3
SOP 505 Training Requirements and Creating and Maintaining Training Records  SOP 505 v1.4
SOP 510 Medical Cover for Clinical Research Trials  SOP 510 v1.4
SOP 600 Creating a Statistical Analysis Plan SOP 600 v1.4
SOP 605 Sample Size Calculation  SOP 605 v1.4
SOP 700 NNUH Vendor Selection Approval and Oversight SOP 700 v1.0 
SOP 705 Quality Control and Quality Assurance  SOP 705 v1.6
SOP 710 Audit and Inspection  SOP 710 v1.3
SOP 715 Principles of Clinical Research Laboratory Practice  SOP 715 v1.5
 SOP  720  Risk Assessment of Trials Sponsored by the NNUH and UEA   SOP 720 v1.1
  SOP 725 Capacity Capability and Risk Assessment NNUH Hosted Studies   SOP 725 v1.1
SOP 800 Non Study Specific Documentation Management  SOP 800 v1.4
SOP 805 Clinical Data Management System – CDMS SET-UP  SOP 805 v2.2
SOP 810 Clinical Data Management System- SPECIFICATION, DEVELOPMENT, TEST AND DEPLOYMENT  SOP 810 v2.2
SOP 815 Clinical Data Management System- LOCKING AND UNLOCKING THE DATA BASE  SOP 815 v2.2
SOP 820 Clinical Data Management System : MAINTENANCE AND SUPPORT SOP 820 v2.2
SOP 825 Clinical Data Management System : VALIDATION  SOP 825 v2.2
SOP 835 Clinical Data Management System: EMERGENCY UNBLINDING  SOP 835 v2.2
SOP 840 Clinical Data Management System: DATA MANAGEMENT AND SECURITY  SOP 840 v2.2
SOP 850 Clinical Data Management System: CLOSEDOWN SOP 850 v2.2
SOP 855 Clinical Data Management System: MANIPULATION OF DATA AFTER EXPORT  SOP 855 v1.3
SOP 860 Clinical Data Management System- DATA REQUEST  SOP 860 v1.2
SOP 865 Study Specific Document Management  SOP 865 v1.0
SOP 900  Storage and Retention of Research Documents SOP 900 v1.5
   Related Pharmacy SOPs  
2.9c-1 PHARMACY SERVICES: Procedure for the Labelling Requirements of Investigational Medicinal Products  V3.0
2.9e/3 Standard Operating Procedure for the Management of Investigational Medicinal Products in the CRF at Quadram Institute  V1.1
 2.9b/14 PHARMACY SERVICES: Standard Operating Procedure for the Management of IMP Outside Pharmacy V2.0
   For copies of the Pharmacy SOP’s please contact Gail Healey (