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
|SOP-QA-3||V5||Protocol Guidance for High Risk Trials and CTIMPs|
|SOP-QA-4||V4||Applying for Sponsorship|
|SOP-QA-6||V4||Study Start Up|
|SOP-QA-7||V3||Trial Master File|
|SOP-QA-8||V3||Investigator Site File|
|SOP-QA-10||V4||Applying for Research Ethics Committee Opinion|
|SOP-QA-13||V4||Generation of Contracts|
|SOP-QA-14||V4||SmPC, Investigator Brochure and IMP Dossier|
|SOP-QA-16||V4||Selection and Management of Third Parties|
|SOP-QA-38||V3||Equipment and Facilities||
|V3||Multi-centred site selection||-|
|SOP-QA-41||V2||Genetically Modified Micro-organism research
|SOP-QA-9||V6||Receiving Informed Consent|
|SOP-QA-15||V3||Management of Medicinal Products used in Research|
Data Management & Statistics
|SOP-QA-12||V4||Case Report Forms|
|SOP-QA-18||V4||Randomisation & Blinding for Controlled Trials||
|SOP-QA-23||V3||Statistical Analysis Plans for Clinical Trials||-|
|SOP-QA-27||V4||Good Documentation Practice||-|
Pharmacovigilance & Regulatory
|SOP-QA-21||V4||APRs and DSURs|
|SOP-QA-22||V5||Adverse Events in CTIMPs|
|SOP-QA-25||V4||Deviations and Breaches|
|SOP-QA-39||V3||Adverse Events in Medical Device Clinical Investigations|
|SOP-QA-42||V1||Urgent Safety Measures|
|SOP-QA-43||V1||Suspected Serious Breaches|
Study Close Out
|SOP-QA-31||V4||Research Project Closure||-|
|SOP-QA-33||V4||Research Project Publications and Dissemination|
Monitoring & Audit
|SOP-QA-1||V4||Managements of SOPs||
|SOP-QA-24||V3||Managing a Change in Chief Investigator of a CTIMP or Medical Device Clinical Investigation||-|
|SOP-QA-34||V6||Good Clinical Practice/Good Research Practice Training *|
|SOP-QA-36||V4||Retention of Health Records of Clinical Trial Patients||
|UoA NHSDigital SOP||V3||NHSDigital Data Access, Storage and Management (UoA only)|
* 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.