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	CTIMP Protocol Template Non-CTIMP protocol template
SOP-QA-4	Applying for Sponsorship	V6 15-11-2023	DPIA requirement
SOP-QA-6	Study Start Up	V5 21-06-2024	Trial Master File Index SAE Reporting Form Pregnancy Notification Form Sponsor File Index ISF Index
SOP-QA-7	Trial Master File	V4 09-08-2023	Trial Master File Index Site Delegation Log Template Sponsor File Index ISF Index Note to file
SOP-QA-8	Investigator Site File	V4 09-08-2023	Site Delegation Log Template ISF Index Note to file
SOP-QA-10	Applying for Research Ethics Committee Opinion	V5 05-06-2023	Participant Information Sheet (PIS) Guide
SOP-QA-13	Generation of Contracts	V5 09-08-2023	Analytical Protocol
SOP-QA-14	SmPC, Investigator Brochure and IMP Dossier	V5 09-08-2023	Investigator Brochure Template
SOP-QA-16	Selection and Management of Third Parties	V4 30-11-2021	Analytical Protocol Third Party List
SOP-QA-38	Equipment and Facilities	V3 01-06-2022	SOP Template Temperature monitoring log
SOP-QA-40	Multi-centred site selection	V4 21-06-2024	-
SOP-QA-41	Genetically Modified Micro-organism research (NHSG only)	V2 01-06-2022	Site Delegation Log Template

Study Conduct

Reference	Title	Version and Effective Date	Associated Document(s)
SOP-QA-9	Receiving Informed Consent	V6 01-05-2023	Informed Consent Form Site Delegation Log Template Participant Information Sheet (PIS) Guide Verbal Informed Consent Form
SOP-QA-15	Management of Medicinal Products used in Research	V4 09-08-2023	Site Delegation Log Template Research Project Prescription MP Order Form MP Request Form Temperature Monitoring Log Local MP Accountability Log Green Light Form Emergency Unblinding Form
SOP-QA-17	Project Committees	V6 21-06-2024	-
SOP-QA-19	Amendments	V6 09-07-2023	Amendment Log

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	Site Delegation Log Template Note to file

Pharmacovigilance & Regulatory

Reference	Title	Version and Effective Date	Associated Document(s)
SOP-QA-21	APRs and DSURs	V4 11-10-2022	DSUR Template DSUR Example Non-commercial Sponsor
SOP-QA-22	Adverse Events in CTIMPs	V5 11-10-2022	SAE Reporting Form Trial Log of SAEs Pregnancy Notification Form Site Delegation Log Template
SOP-QA-25	Deviations and Breaches	V5 21-03-2024	Breach Report Form Log of Breaches and Urgent Safety Measures Log of Deviations Note to file
SOP-QA-30	MHRA Inspections	V4 30-11-2021	-
SOP-QA-35	Unblinding	V5 09-08-2023	Emergency Unblinding Form
SOP-QA-39	Adverse Events in Medical Device Clinical Investigations	V4 20-12-2023	Pregnancy Notification Form Site Delegation Log Template Medical Device Vigilance Report Medical Device Deficiency/User Error Report SAE report table
SOP-QA-42	Urgent Safety Measures	V1 30-11-2021	Log of Breaches and Urgent Safety Measures
SOP-QA-43	Suspected Serious Breaches	V1 30-11-2021	Breach Report Form Log of Breaches and Urgent Safety Measures Log of Deviations

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	Archive Destruction Form Archive Approval Form Archive Retrieval Form Archive Review Notice
SOP-QA-33	Research Project Publications and Dissemination	V5 20-12-2023	Self Certificate Form

Monitoring & Audit

Reference	Title	Version and Effective Date	Associated Document(s)
SOP-QA-28	Monitoring	V5 01-12-2022	Log of Breaches and Urgent Safety Measures Monitoring Plan Monitoring Feedback Form Subject Log Source Data Identification List  Document Version Control Log
SOP-QA-29	Audit	V4 09-08-2023	CAPA Template

Administration

Reference	Title	Version and Effective Date	Associated Document(s)
SOP-QA-1	Managements of SOPs	V5 09-08-2023	SOP Template Document Creation Form SOP Review Form (including change requests)
SOP-QA-2	Training Record	V5 21-06-2024	Training Log SOP Sign off Sheet Employee Training Record (CV Template) Quality Management System Matrix
SOP-QA-24	Managing a Change in Chief Investigator of a CTIMP or Medical Device Clinical Investigation	V4 09-08-2023	Site Delegation Log Template
SOP-QA-34	Good Clinical Practice/Good Research Practice Training	V6 06-01-2022	Employee Training Record (CV Template) Site Delegation Log Template
SOP-QA-36	Retention of Health Records of Clinical Trial Patients	V5 21-06-2024	-
SOP-QA-37	Management Review	V4 09-08-2023	Management Review Agenda
SOP-R&D-8-NHSG	Remote Monitoring and Source Data Verification (NHSG only)	V2 01-05-2024
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.