SOPs and Templates

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SOPs and Templates

University of Aberdeen - NHS Grampian joint Sponsor SOPs

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.

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Reference Title Version Effective Date Review Date Associated Document(s) Category
ST-1 Quality Statement V7 01/05/2024 01/05/2027   01 Getting Ready
QM-1 Research & Development Quality Manual V6 02/07/2024 02/07/2027   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 Protocol guidance for high risk trials and CTIMPs V6 19/12/2024 19/12/2027 01 Getting Ready
SOP-QA-4 Applying for Sponsorship V6 15/11/2023 15/11/2026 01 Getting Ready
SOP-QA-6 Study Start Up V5 21/06/2024 21/06/2027 02 Getting Started
SOP-QA-7 Trial Master File V4 09/08/2023 09/08/2026 02 Getting Started
SOP-QA-8 Investigator Site File V4 09/08/2023 09/08/2026 02 Getting Started
SOP-QA-9 Receiving Informed Consent V6 01/05/2023 01/05/2026 02 Getting Started
SOP-QA-10 Applying for Research Ethics Committee opinion V6 19/12/2024 19/12/2027 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

SmPC, Investigator Brochure and IMP Dossier

V5 09/08/2023 09/08/2026 02 Getting Started
SOP-QA-15 Management of Medicinal Products used in Research V4 09/08/2023 09/08/2026 02 Getting Started
SOP-QA-16 Selection and management of contracted third parties V5 19/12/2024 19/12/2027 02 Getting Started
SOP-QA-17 Project Committees V6 21/06/2024 21/06/2027   02 Getting Started
SOP-QA-18 Randomisation & Blinding for Controlled Trials V5 09/08/2023 09/08/2026   02 Getting Started
SOP-QA-19 Amendments V6 09/07/2023 09/07/2026 04 Active Phase, 05 Safety Reporting
SOP-QA-20 Data Management V4 09/08/2023 09/08/2026   04 Active Phase

SOP-QA-21

DSURs V5 16/10/2025 16/10/2028 04 Active Phase
SOP-QA-22 Adverse Events in CTIMPs V6 16/10/2025 16/10/2028 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 Managing a Change in Chief Investigator of a CTIMP or Medical Device Clinical Investigation V4 09/08/2023 09/08/2026 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 V6 26/11/2025 26/11/2028 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 Research project closure V5 21/05/2025 21/05/2028   06 End of Study
SOP-QA-32
*UPDATED
Archiving V6 26/11/2025 26/11/2028 06 End of Study
SOP-QA-33 Research Project Publications and Dissemination V5 20/12/2023 20/12/2026 06 End of Study
SOP-QA-34 Good Clinical Practice and Good Research Practice Training * V7 11/02/2025 11/02/2028 02 Getting Started
SOP-QA-35 Unblinding V5 09/08/2023 09/08/2026 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 Urgent Safety Measures V2 19/12/2024 19/12/2027 02 Getting Started, 05 Safety Reporting
SOP-QA-43 Suspected serious breaches V2 19/12/2024 19/12/2027 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 andor Specim 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

 

* During the Global COVID-19 Health Pandemic the required frequency of Good Clinical Practice (GCP) and Good Research Practice (GRP) refresher training, detailed in SOP-QA-34, was extended from two years to three years. This was for the duration of the declared COVID-19 pandemic only.

This temporary situation has now been revoked and the required frequency of refresher training has returned to two years from May 17 2022. All staff involved in the conduct of clinical trials are expected to attend approved training if the time since their last refresher is more than two years.

Please note that if the duration since the last Good Clinical Practice (GCP) introduction or refresher training exceeds three years, a researcher must complete the Introduction to Good Clinical Practice (GCP) training, rather than the refresher training.