SOPs and Templates

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.

Study Set Up

Reference Title Version and Effective Date Associated Document(s)
SOP-QA-3 Protocol Guidance for High Risk Trials and CTIMPs

V5 
06-01-2022

SOP-QA-4 Applying for Sponsorship V6
15-11-2023
SOP-QA-6 Study Start Up V4
21-06-2021
SOP-QA-7 Trial Master File V4
09-08-2023
SOP-QA-8 Investigator Site File V4
09-08-2023
SOP-QA-10 Applying for Research Ethics Committee Opinion V5
05-06-2023
SOP-QA-13 Generation of Contracts

V5
09-08-2023

SOP-QA-14 SmPC, Investigator Brochure and IMP Dossier V5
09-08-2023
SOP-QA-16 Selection and Management of Third Parties V4
30-11-2021
SOP-QA-38 Equipment and Facilities V3
01-06-2022

SOP-QA-40

Multi-centred site selection V3
21-06-2021
      -
SOP-QA-41 Genetically Modified Micro-organism research
(NHSG only)
V2
01-06-2022

Study Conduct

Reference Title Version and Effective Date Associated Document(s)
SOP-QA-9 Receiving Informed Consent V6
01-05-2023
SOP-QA-15 Management of Medicinal Products used in Research V4
09-08-2023
SOP-QA-17 Project Committees V5
21-06-2021
       - 
SOP-QA-19 Amendments V6
09-07-2023

Data Management & Statistics

Reference Title Version and Effective Date Associated Document(s)
SOP-QA-12 Case Report Forms V5
20-12-2023
      -
SOP-QA-18 Randomisation & Blinding for Controlled Trials V5
09-08-2023

      -

SOP-QA-20 Data Management V4
09-08-2023
      -
SOP-QA-23 Statistical Analysis Plans for Clinical Trials V4
09-08-2023
      -
SOP-QA-27 Good Documentation Practice V4
01-06-2022

Pharmacovigilance & Regulatory

Reference Title Version and Effective Date Associated Document(s)
SOP-QA-21 APRs and DSURs V4
11-10-2022
SOP-QA-22 Adverse Events in CTIMPs V5
11-10-2022
SOP-QA-25 Deviations and Breaches V4
30-11-2021
SOP-QA-30 MHRA Inspections V4
30-11-2021
      -
SOP-QA-35 Unblinding V5
09-08-2023
SOP-QA-39  Adverse Events in Medical Device Clinical Investigations V4
20-12-2023
SOP-QA-42 Urgent Safety Measures V1
30-11-2021
SOP-QA-43 Suspected Serious Breaches V1
30-11-2021

Study Close Out

Reference Title Version and Effective Date Associated Document(s)
SOP-QA-31 Research Project Closure V4
01-06-2022
      -
SOP-QA-32 Archiving V5
01-12-2022
SOP-QA-33 Research Project Publications and Dissemination V5
20-12-2023

Monitoring & Audit

Reference Title Version and Effective Date Associated Document(s)
SOP-QA-28 Monitoring V5
01-12-2022
SOP-QA-29 Audit V4
09-08-2023

Administration

Reference Title Version and Effective Date Associated Document(s)
SOP-QA-1 Managements of SOPs V5
09-08-2023
SOP-QA-2 Training Record V4
21-06-2021
SOP-QA-24 Managing a Change in Chief Investigator of a CTIMP or Medical Device Clinical Investigation V4
09-08-2023
SOP-QA-34 Good Clinical Practice/Good Research Practice Training * V6
06-01-2022
SOP-QA-36 Retention of Health Records of Clinical Trial Patients V4
21-06-2021

      -

SOP-QA-37 Management Review V4
09-08-2023
SOP-R&D-8-NHSG Remote Monitoring and Source Data Verification (NHSG only) V1
16-02-2021
 
UoA NHS England Data Management SOP NHS England Data Access, Storage and Management (UoA only) V4
04-08-2023
 

 

* 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.