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 | 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 |
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 | 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.