QMS - two new SOPs
New Compliance Review SOP and Project Oversight & Quality Management SOP. These SOPs will both become effectiv as of 25-Oct-2021, and are applicable to clinical studies and clinical trials.
New Standard Operating Procedures (SOPs) for Clinical Research
- Type: SOP (applicable to clinical studies and clinical trials)
- QMS code: UoB-CPR-SOP-001
- Version: 1.0
- Effective date: 25-Oct-2021
This SOP describes the processes for ensuring quality in clinical research projects. This includes the approval of vendors, and the implementation and management of compliance programmes, such as the audit programme. The SOP replaces UoB-GEN-AUD-SOP-001 Audits v2.0 and UoB-CLN-VEN-SOP-001 Vendor Management v1.0.
- Type: SOP (applicable to clinical studies and clinical trials)
- QMS code: UoB-POS-SOP-001
- Version: 1.0
- Effective date: 25-Oct-2021
This SOP describes the procedures for establishing appropriate project oversight and quality management strategies, based on the type of the clinical research and associated risk. This SOP replaces UoB-CLN-TQM-SOP-001 Trial Quality Management v2.0.
See the Quality Management System (QMS) for further details and to access the full UoB QMS for Clinical Research.