Clinical Research Office. A partnership between Sheffield Teaching Hospitals NHS Foundation Trust and the University of Sheffield

Standard Operating Procedures (SOPs)

Sheffield Teaching Hospitals NHS Foundation Trust has a responsibility to ensure that all research within the Trust is conducted in accordance with the relevant legislation and guidelines. In order to assist research teams in fulfilling their obligations, the Clinical Research Office has developed a suite of SOPs covering key activities. These SOPs should be included in the study Site File.

Current SOPs

SOP Number SOP Title
A107   Project registration
A108 Recording of research information in patient medical records
A109   Independent Scientific Review
A112   Using STH Generic Case Report Form
A116   Investigator Site File
A117   Delegation of Study Duties
A124   Maintaining the Case Report Form (CRF) for externally sponsored studies
A125   Responding to Data Queries
A126   Sponsor Monitoring of STH Sponsored IMP Studies
A127   Archiving of Essential Documents Generated During Clinical Research
C101   Document version control
C102   Confidentiality for commercially sponsored clinical research
C103   Data Protection Act & Research
C104   Indemnity for Research
C105   Amendments
C106   Misconduct and Fraud
C107   Regulatory Inspection
C108   Sponsorship
C109   Code break procedures for STH Sponsored IMP clinical trials
C113   Radiation in Research
C114   RfPB
C116   Material transfer agreement for the transfer of human tissue
C117   Pharmacovigilance
C118   Risk Assessment of STH sponsored CTIMPs
C119  Execution of Clinical Trial Agreements (CTA) and Clinical Investigation Agreements (CIA) for Commercially Sponsored Clinical Trials
C120  The Use of Human Tissue in Research
C121  Clinical Trial Agreements (CTA) for Non-Commercially Sponsored Trials
C122  Gene Therapy Research: Local Safety Group Approval
C123  Intellectual Property
C124  Project Authorisation
C125  Protocol Non-Compliance & management of serious breaches
C126  For Cause Audits
C127

 Human Tissue Audits

Ideas for additional SOPs

We would welcome your suggestions for any standard procedures that you feel that would benefit from an SOP. Please contact Zoe Whiteley (Zoe.Whiteley@sth.nhs.uk).

Writing study specific SOPs

If you have study specific procedures for which you need to create an SOP, we can provide you with a template SOP document and guidelines for completion. Also, if you feel you would benefit from support in writing your study specific SOPs in the form of one to one or group training, please contact Zoe Whiteley (Zoe.Whiteley@sth.nhs.uk).