Updated Project Closure SOP (effective as of 22-Mar-2021), Archiving SOP (effective as of 29-Mar-2021) and Adverse Event Reporting SOP (effective as of 19-Apr-2021). All now applicable to clinical studies and trials.
Updated Standard Operating Procedures (SOPs) for Clinical Research
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.
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:
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.
