QMS - three recently updated SOPs

Updated Standard Operating Procedures (SOPs) for Clinical Research 

Project Closure SOP (Word - 77 KB)

  • Type: SOP (applicable to clinical studies and clinical trials)
  • QMS code: UoB-CLO-SOP-001  
  • Version: 1.0
  • Effective date: 22-Mar-2021

The purpose of this SOP is to describe the requirements relating to project closure. This includes notification for the end of project, early termination, and abandoned projects. It outlines the requirements for the final report on research and publications including project reports, summary reports and reporting requirements for trial registries. Furthermore, it mentions procedures for samples at the end of the project and for archiving. This SOP supersedes UoB-CLN-EOT-SOP-001 End of Trial Management v2.0 (EAv1.0), which was previously only applicable to clinical trials. 

Archiving SOP (Word - 198 KB)

  • Type: SOP (applicable to clinical studies and clinical trials)
  • QMS code: UoB-ARC-SOP-001
  • Version: 1.0
  • Effective date: 29-Mar-2021

This SOP describes the procedures for archiving material relevant to clinical research projects and the activities undertaken by the archivist. This SOP supersedes UoB-CLN-ARC-SOP-001 Archiving v1.0, which was previously only applicable to clinical trials. Associated QCDs: 

Adverse Event Reporting SOP (Word - 212 KB)

  • Type: SOP (applicable to clinical studies and clinical trials)
  • QMS code: UoB-AES-SOP-001
  • Version: 1.0
  • Effective date: 19-Apr-2021

This SOP describes the processes involved in Adverse Event (AE) reporting for clinical research projects conducted within UoB. This SOP supersedes UoB-CLN-AES-SOP-001 Adverse Event Reporting v3.0, which was previously only applicable to clinical trials.

See the Quality Management System (QMS) for further details and access to the full UoB QMS for Clinical Research.