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 rdoffice@nnuh.nhs.uk.

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 rdoffice@nnuh.nhs.uk

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 and the NNUH 

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

SOP 206  Identifying, Recording and Reporting Adverse Events for Healthcare Research Studies that are not CTIMPS

SOP 207 Adverse Events: Identifying, Recording and Reporting Adverse Events for Device Trials

Serious Adverse Events Report Form

SOP 210 Managing Protocol and Regulatory Non-Compliance including Serious Breaches

Form for Protocol Deviation, Violation, Breach or Serious Breach of Protocol or GCP – Please contact R&D Office for a copy

SOP 215 Research Study Amendments 

SOP 220 Fraud and Misconduct

SOP 230 Urgent Safety Measures

SOP 305 Creating and Maintaining a Trial Master 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 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 (including procedure for project suspension or early termination)

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

SOP 400 Joint Arrangements for Research Authorisation of Research Sponsorship

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 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 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 720  Risk Assessment of Trials Sponsored by the NNUH and UEA 

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 DATA BASE

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: MANIPULATION OF DATA AFTER EXPORT

SOP 860 Clinical Data Management System- DATA REQUEST

SOP 865 Non Study Specific Documentation Management

SOP 900 Storage and Retention of Research Documents

Pharmacy Related SOP’s For copies of the Pharmacy SOP’s please contact Gail Healey (gail.healey@nnuh.nhs.uk)

2.9b/14 – Procedure for the Management of IMP Outside Pharmacy

2.9c/1 – SOP for the Labelling Requirements of Investigational Medicinal Products

2.9e/1 – Procedure for Clinical Trial Services at the Clinical Research and Trials Unit at the University of East Anglia

2.9e/2 – SOP for the Transfer of Investigational Medicinal Products between NNUH Trust sites

2.9a/2 – Procedure for the Set-up of a Clinical Trial Pharmacy Site File (PSF)

2.9a/3 – Procedure for Pharmacy Confirmation of Readiness

Procedure for Dispensing and Accuracy Checking for Clinical Trials Prescriptions