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Standard Operating Procedures for Research (SOPS)

This section of the site lists the Standard Operating Procedures (SOPs) which apply to all healthcare research within the Trust and UEA.  Most of the SOPs were updated on 1st January 2014 and three new SOPs were added, SOP 206, SOP 345  and SOP 860 as well as thirteen Data Management Templates.

If you have queries about the use of these SOPs or templates, or would like to provide feedback please contact either the Research Trial Monitor on 01603 597305 or the Research Governance Administrator on 01603 597313.

For researchers at the University of East Anglia please provide feedback to Sue Steel, Research Contracts Manager on 01603 591486.

An e-learning module for the SOPs can be found at http://elearning.nnuh.nhs.uk/ under ‘Local NNUH courses; Trust Policies and guidelines; Research & Development SOP training.  You will need a user name and password to access this.

SOP Reference Title Document
SOP 001 Production, Review Approval and Control of SOPs Related to Research Activities  SOP 001v1.2
SOP 205 Identifying, Recording and Reporting Adverse Events for Clinical Trials  SOP 205v2.2
SOP 206 Identifying, Recording and Reporting Adverse Events for Healthcare Research Studies that are not CTIMPS  SOP 206v1.0
  Serious Adverse Events Report Form  SAE form V1.2
SOP 210 Breaches of Good Clinical Practice of the Trial Protocol   SOP 210 v3 0
  Form for Protocol Deviation Deviation Breach or Serious Breach  Form for Protocol Deviation Deviation Breach or Serious Breach v1 01.12.14
SOP 220 Fraud and Misconduct   SOP 220 v1.3
 SOP 230  Urgent Safety Measures  SOP 230v2.0
SOP 305 Creating and Maintaining a Trial Master File  SOP 305v1.2
SOP 310 Development of Participant Information Sheet and Informed Consent Form  SOP 310v1.2
SOP 315 Obtaining Written Informed Consent from Competent Adults in Clinical Trials   SOP 315v1.2
SOP 320 Developing a Research Protocol  SOP 320v2.0
SOP 325 Study Start up Activities for Clinical Research Trials  SOP 325v1.3
SOP 330 Monitoring Clinical Trials  SOP 330 v1.2
SOP 335 Site Study Closedown  SOP 335v1.2
SOP 340 Clinical Trial Reporting  SOP 340v1.1
SOP 345 Identifying Trial Patients on Hospital Admission  SOP 345 v1.2
SOP 350 Designing and Developing a Case Report Form  SOP 350 v1
SOP 351 Compleing a Case Report Form  SOP 351 v1
SOP 400 Joint Arrangements for Research Authorisation of Research Sponsorship SOP 400 v1.3
SOP 405    Obtaining and Maintaining Medicines and Healthcare Products Regulatory Agency (MHRA) Approval for a Clinical Trial  SOP 405 v1.2
 SOP 410 Set up and initiation of an Investigator Site  SOP 410 v1.1
 SOP 505  Creating and Maintaining Training Records  SOP 505 v1.3
  SOP 505 Templates SOP 505 Templates
SOP 510 Medical Cover for Clinical Research Trials SOP 510 v1.2
SOP 600 Creating a Statistical Analysis Plan (updated 17/07/2014)  SOP 600 v1 2  
SOP 605 Sample Size Calculation (updated 17/07/2014)  SOP 605 v1 2  
SOP 705  Quality Control and Quality Assurance  SOP 705 v1.2
SOP 710 Audit and Inspection  SOP 710 v1.2
SOP 715 Principles of Clinical Research Laboratory Practice  SOP 715v1.2
SOP 800 Documentation Management  SOP 800 v1.2
SOP 805 Trial Data Management System - TDMS SET-UP  SOP 805 v2.0
SOP 815  Trial Data Management System - LOCKING AND UNLOCKING THE DATA BASE  SOP 815 v2.0
SOP 820   Trial Data Management System: MAINTENANCE AND SUPPORT  SOP 820 v2.0
SOP 825  Trial Data Management System: VALIDATION SOP 825 v2.0
SOP 835  Trial Data Management System: EMERGENCY UNBLINDING SOP 835 v2.0
SOP 840  Trial Data Management System: DATA MANAGEMENT AND SECURITY   SOP 840 v2.0
SOP 850 Trial Data Management System: CLOSEDOWN  SOP 850v2.0
SOP 855 Trial Data Management System: MANIPULATION OF DATA AFTER EXPORT   SOP 855 v1.1
SOP 860 Trial Data Management System - DATA REQUEST  SOP 860 v1.0
NEW   1.  Data Management Plan Template Template 1_v1.0.
NEW  2.  Functional Specification Template  Template 2_v2.0
NEW   3. Data Dictionary Template Template 3_v1.0
NEW  4.  TDMS Users Log Template Template 4_v1.0
NEW  5.  System Acceptance Template Template 5_v1.0
NEW  6.  Data Validation Plan - Report Template   Template 6_v1.0
NEW  7.  Defect List Template   Template 7_v2.0
NEW  8.  Release Note Template   Template 8_v2.0
NEW  9.  Emergency Unblinding Form Template  Template 9_v2.0
NEW  10. Dataset Request Form Template Template 10_v1.0
 NEW  11. Database Lock Request Template  Template 11_v1.0
NEW  12. Database Unlock Request Template  Template 12_v1.0
 NEW  13  Database Closedown Request Template   Template 13_v2.0
SOP 900 Storage and Retention of Research Documents  SOP 900 v1.2
  Related Pharmacy SOPs  


PHARMACY SERVICES: Procedure for the Labelling Requirements of Investigational Medicinal Products  SOP 2.9c-1 v1
 2.9e/1 PHARMACY SERVICES: Procedure for Clinical Trial Services at the Clinical Research and Trials Unit at the University of East Anglia  SOP 2.9e/1 v1.0
  2.9e/2  PHARMACY SERVICES: Standard Operationg Procedure for the Transfer of Investigational Medicinal Products between NNUH Trust sites  SOP 2.9e/2 v1.0
  2.9b/14  PHARMACY SERVICES: Standard Operating Procedure for the Management of IMP Outside Pharmacy  SOP 2.9b/14 v1.0

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