SOPs and Templates

In this section
SOPs and Templates

University of Aberdeen - NHS Grampian joint Sponsor SOPs

On 28-04-2026, the UK adopted the ICH Guideline for Good Clinical Practice (GCP) E6 (R3). On the same day the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 became law and both now apply to all regulated clinical trial activity in the UK.

The NHSG-UoA Quality Statement, Quality Manual and 24 of the SOPs have been updated to comply and are highlighted as such below. Where applicable GCP training shall require updating no later than 31st December 2026. Thereafter, your GCP training will need renewed every three years (rather than two). Please see training page for available dates.

Standard Operating Procedures (SOPs) are detailed, written instructions which must be followed when performing certain tasks. They are an essential source for communicating to researchers the agreed, defined methodology which must be followed to ensure consistency between researchers and, in multi-centre studies, the consistency between individual research sites.

As sponsors and hosts of clinical research, the University of Aberdeen and NHS Grampian have a legal responsibility regarding the oversight and management of studies.

On this page you will find a range of SOPs for investigators and researchers which are written to ensure that studies are conducted and reported in compliance with the principles of Good Clinical Practice (GCP), regulatory requirements and the UK Policy Framework for Health & Social Care Research. Local, or study specific SOP may also be required and these should be prepared by the Chief Investigator as required.

Templates may also be associated with some SOPs and these can be downloaded as Word documents if required.

For information on SOP training which may be available, please visit the NHS Grampian Research and Development webpage.

Upon commencing involvement in a Clinical Trial all researchers must read the relevant documents which make up the Quality Management System. Researchers should use the Quality Management System Matrix to record which documents they have read and the version number, and retain in their training record.

Please check this page regularly as new SOPs may become available or updated versions may be added.

Search: Clear Filters

Reference Title Version Effective Date Review Date Associated Document(s) Category
ST-1
*UPDATED
Quality Statement V8 28/04/2026 28/04/2029   01 Getting Ready
QM-1
*UPDATED
Research & Development Quality Manual V7 28/04/2026 28/04/2029   01 Getting Ready
SOP-QA-1 Managements of SOPs V5 09/08/2023 09/08/2026 01 Getting Ready
SOP-QA-2 Training Record V5 21/06/2024 21/06/2027 01 Getting Ready
SOP-QA-3
*UPDATED
Protocol guidance for high risk trails and CTIMPs V7 28/04/2026 28/04/2029 01 Getting Ready
SOP-QA-4
*UPDATED
Applying for sponsorship V7 28/04/2026 28/04/2029 01 Getting Ready
SOP-QA-6
*UPDATED
Study start-up V6 28/04/2026 28/04/2029 02 Getting Started
SOP-QA-7
*UPDATED
Trial Master File V5 28/04/2026 28/04/2029 02 Getting Started
SOP-QA-8
*UPDATED
Investigator Site File V5 28/04/2026 28/04/2029 02 Getting Started
SOP-QA-9
*UPDATED
Receiving informed consent V7 28/04/2026 28/04/2029 02 Getting Started
SOP-QA-10
*UPDATED
Applying for Research Ethics Committee opinion V7 28/04/2026 28/04/2029 02 Getting Started
SOP-QA-12 Case Report Forms V5 20/12/2023 20/12/2026   02 Getting Started
SOP-QA-13 Generation of Contracts V5 09/08/2023 09/08/2026 02 Getting Started
SOP-QA-14
*UPDATED
SmPC IB and IMP Dossier V6 28/04/2026 28/04/2029 02 Getting Started

SOP-QA-15
*UPDATED

Management of Medicinal Products used in research V5 28/04/2026 28/04/2029 02 Getting Started
SOP-QA-16
*UPDATED
Selection and management of contracted third parties V6 28/04/2026 28/04/2029 02 Getting Started
SOP-QA-17
*UPDATED
Project committees V7 28/04/2026 28/04/2029   02 Getting Started
SOP-QA-18 Randomisation & Blinding for Controlled Trials V5 09/08/2023 09/08/2026   02 Getting Started
SOP-QA-19
*UPDATED
Modifications V7 28/04/2026 28/04/2029 04 Active Phase, 05 Safety Reporting
SOP-QA-20 Data Management V4 09/08/2023 09/08/2026   04 Active Phase

SOP-QA-21
*UPDATED

DSURs V6 28/04/2026 28/04/2029 04 Active Phase
SOP-QA-22
*UPDATED
Adverse Events in CTIMPs V7 28/04/2026 28/04/2029 04 Active Phase, 05 Safety Reporting
SOP-QA-23 Statistical Analysis Plans for Clinical Trials V4 09/08/2023 09/08/2026   04 Active Phase
SOP-QA-24
*UPDATED
Managing a change of Chief Investigator in a CTIMP or MDCI V5 28/04/2026 28/04/2029 04 Active Phase
SOP-QA-25 Deviations and breaches V6 19/12/2024 19/12/2027 04 Active Phase, 05 Safety Reporting
SOP-QA-27 Good documentation practice V5 21/05/2025 21/05/2028 04 Active Phase, 03 Quality Assurance

SOP-QA-28
*UPDATED

Monitoring V7 28/04/2026 28/04/2029 03 Quality Assurance
SOP-QA-29 Audit V4 09/08/2023 09/08/2026 03 Quality Assurance
SOP-QA-30 MHRA inspections V5 19/12/2024 19/12/2027   03 Quality Assurance
SOP-QA-31
*UPDATED
Research project closure V6 28/04/2026 28/04/2029   06 End of Study
SOP-QA-32 Archiving V6 26/11/2025 26/11/2028 06 End of Study
SOP-QA-33
*UPDATED
Research project publication and dissemination V6 28/04/2026 28/04/2029 06 End of Study
SOP-QA-34
*UPDATED
GCP and Good Research Practice Training V8 28/04/2026 28/04/2029 02 Getting Started
SOP-QA-35
*UPDATED
Unblinding V6 28/04/2026 28/04/2029 04 Active Phase, 05 Safety Reporting
SOP-QA-36 Retention of Health Records of Clinical Trial Patients V5 21/06/2024 21/06/2027   06 End of Study
SOP-QA-37 Management Review V4 09/08/2023 09/08/2026 03 Quality Assurance
SOP-QA-38 Equipment and Facilities V4 21/05/2025 21/05/2028 04 Active Phase
SOP-QA-39 Adverse Events in Medical Device Clinical Investigations V4 20/12/2023 20/12/2026 04 Active Phase, 05 Safety Reporting
SOP-QA-40 Multi-centred site selection V4 21/06/2024 21/06/2027   02 Getting Started
SOP-QA-41 Genetically Modified Micro-organism research (NHSG only) V3 21/05/2025 21/05/2028 02 Getting Started
SOP-QA-42
*UPDATED
Urgent Safety Measures V3 28/04/2026 28/04/2029 02 Getting Started, 05 Safety Reporting
SOP-QA-43
*UPDATED
Suspected serious breaches V3 28/04/2026 28/04/2029 02 Getting Started, 05 Safety Reporting
UoA NHSDigital SOP

NHSDigital Data Access, Storage and Management (UoA only)

V5 18/12/2024 18/12/2026    
             
SOP-CRF-1 What to do in the Event of Spillage of Bodily Fluids and/or Specimens V4 16/10/2025 16/10/2028   07 CRF
SOP-CRF-2 Dealing with a needle-stick or mucous membranes exposure to blood V4 16/10/2025 16/10/2028   07 CRF
SOP-CRF-3 Disposal of Waste Materials from the Clinical Research Facility V4 16/10/2025 16/10/2028   07 CRF
SOP-CRF-4 Cleaning Procedures within the Clinical Research Facility and HSB V4 16/10/2025 16/10/2028   07 CRF
SOP-CRF-5 Late Night-Lone Working Policy in the CRF in HSB V4 18/03/2025 18/03/2028   07 CRF
SOP-CRF-6 Storage of Hospital Notes in the CRF in HSB V4 06/09/2025 06/09/2028   07 CRF
SOP-CRF-7 What to do in the Event of Spillage of Bodily Fluids and or Specimens in NHSG V2 12/09/2023 12/09/2026   07 CRF
SOP-CRF-8 Dealing with a needle-stick or mucous membrane exposure to blood or body fluids V3 30/10/2023 30/10/2026   07 CRF