University of Aberdeen - NHS Grampian joint Sponsor SOPs

Due to the Coronavirus pandemic the scheduled periodic review of SOPs was delayed from April 1 2020 to August 1 2020. Those SOPs which have been reviewed are indicated below with *. Please ensure you are using the most up to date version.

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.

Please check this page regularly as new SOPs may become available or updated versions may be added.

Study Set Up

Reference Version Title Associated Document(s)
SOP-QA-3 V4 Protocol Guidance for use in High Risk Trials and CTIMPs
SOP-QA-4* V4 Applying for Sponsorship
SOP-QA-6 V3 Study Start Up
SOP-QA-7* V3 Trial Master File
SOP-QA-8* V3 Investigator Site File
SOP-QA-16 V3 Selection and Management of Third Parties
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-38 V2 Equipment

      -

SOP-QA-40

V2 Multi-centred site selection       -
SOP-QA-41 V1 Genetically Modified Micro-organism research           (NHSG only)       -

Study Conduct

Reference Version Title Associated Document(s)
SOP-QA-9 V4 Receiving Informed Consent
SOP-QA-17 V4 Project Committees

      -

SOP-QA-19 V5 Amendments
SOP-QA-15* V3 Management of Medicinal Products used in Research

Data Management & Statistics

Reference Version Title Associated Document(s)
SOP-QA-18* V4 Randomisation & Blinding for Controlled Trials

     -

SOP-QA-20* V3 Data Management       -
SOP-QA-23* V3 Statistical Analysis Plans for Clinical Trials       -
SOP-QA-12 V3 Case Report Forms
SOP-QA-27 V3 Good Documentation Practice       -

Pharmacovigilance & Regulatory

Reference Version Title Associated Document(s)
SOP-QA-21* V3 APRs and DSURs
SOP-QA-22 V3 Adverse Events in CTIMPs
SOP-QA-25 V3 Deviations and Breaches
SOP-QA-30 V3 MHRA Inspections       -
SOP-QA-35* V4 Unblinding       -
SOP-QA-39 V2 Adverse Events in Medical Device Clinical Investigations

Study Close Out

Reference Version Title Associated Document(s)
SOP-QA-31* V3 Research Project Closure       -
SOP-QA-32 V4 Archiving
SOP-QA-33* V3 Research Project Publications and Dissemination

Monitoring & Audit

Reference Version Title Associated Document(s)
SOP-QA-28 V3 Monitoring
SOP-QA-29* V3 Audit

Administration

Reference Version Title Associated Document(s)
SOP-QA-2 V3 Training Record
SOP-QA-24* V3 Managing a Change in Chief Investigator of a CTIMP or Medical Device Clinical Investigation       -
SOP-QA-1* V4 Managements of SOPs

 

SOP-QA-34 V5 Good Clinical Practice/Good Research Practice Training
SOP-QA-36 V3 Retention of Health Records of Clinical Trial Patients

      -

SOP-QA-37* V3 Management Review