QMS - three new SOPs
Updates to the Standard Operating Procedures (SOPs) for Clinical Research
The purpose of this quality manual is to explain the University of Birmingham’s (UoB) framework for conducting clinical research.
- Type: Quality Manual (applicable to clinical studies and clinical trials)
- QMS code: UoB-CQM-POL-001
- Version: 1.0
- Effective date: 04-Apr-2022
- Supersedes: Clinical Trials Quality Manual v1.0 (EAv1.0) & Research Quality Manual v1.0
This SOP describes the procedure for the development, review, implementation and filing of Essential Documents, and provides further instructions and templates with regards to the development of a number of the Essential Documents, e.g. the Protocol.
- Type: SOP (applicable to both clinical trials and clinical studies)
- QMS code: UoB-ESD-SOP-001
- Version: 1.0
- Effective date: 04-Apr-2022
- Supersedes: UoB-CLN-ESD-SOP-001 Essential Documents Development & Maintenance v3.0 (EAv1.0)
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.
- Type: SOP (applicable to clinical studies and clinical trials)
- QMS code: UoB-SET-SOP-001
- Version: 1.0
- Effective date: 04-Apr-2022
- Supersedes: Clinical Trials Quality Manual v1.0 (EAv1.0) & Research Quality Manual v1.0
See the Quality Management System (QMS) for further details and to access the full UoB QMS for Clinical Research.