Policies and SOPs

• All staff working on a clinical trial of an investigational medicinal product (CTIMPs and Medical Devices), please see the University Policy for Compliance with The Medicines for Human Use and the Policy for Medical Devices.
• Please note the policy and SOPs on this page are controlled documents.
• Any printed version of any of the documents may not be current.
  It is the responsibility of colleagues to ensure that the most recent version of the document is accessed and the procedures stated within the document are being followed.

Policies

Current Clinical Trials Policy

• UM/11/POL/CTIMP/004 - Policy for Compliance with The Medicines for Human use (Clinical Trials) Regulations 2004 and subsequent amendments (Investigational Medicinal Products) and other Clinical Research

 Clinical Trials Insurance Policy

• Forther information about insurance cover for research studies involving human subjects (Clinical Trials).

Clinical Trial Management Group (CTMG) Terms of Reference (.doc)

Standard Operating Procedures.

Applicable, as appropriate, for CTIMP, Medical Device and other high risk studies

Sponsorship

• University Sponsorship of a Clinical Trial
• Registration of non-University of Manchester CTIMP
  • Appendix I: Registration of non-University of Manchester CTIMP
• Assessment of Suitability of a co-Sponsor
• Delegation of Responsibilities

Study Setup and Conduct

• Creation and the Maintenance of a Trial Master File
• Document Control
• Clinical Trial Authorisation
• Substantial and non-Substantial Amendments
  • Annex I: Substantial and non-Substantial Amendments
• Data monitoring and Ethics Committee / Trial Steering Committee

Third Parties

• Vendor Selection and Oversight
• Clinical Trials Unit (CTU)

IT/Data Management

• Computerised Systems for Clinical Trials
• Data Management
• IT Security and Encryption
• System Level Security Policy
• Case Report Form (CRF)

Pharmacovigilance & Regulatory

• Pharmacovigilance - SAEs
• Pharmacovigilance - DSURs
• Urgent Safety Measures
• Reporting a Serious Breach
• Reporting Adverse Events for Medical Devices

Pharmacy Support

• Pharmacy Support for CTIMPs
• Appendix 1
• Appendix 2
• Appendix 3
• Product Recall

Monitoring & Audit

• Monitoring

Archiving

• Archiving

Publication

• Publication

UoM RGEIT team related SOPs

• Training 
• SOP for SOP

The Clinical Trials team is drafting a number of new SOPs for medical devices that should be available in the next couple of months. These include:

- Good Documentation Practice

- Quality Control

- Hosting Regulatory Inspections

- Medical Device Risk Assessment

- Non-Conformance, Root Cause Analysis, and CAPA

Contact

For any queries relating to the policies, procedures and SOPs related to clinical trials, please contact the Research Governance, Ethics and Integrity Manager for Clinical Trials:

Dr Mohammed Zubair
Directorate of Research and Business Engagement
Christie Building
The University of Manchester
Manchester
M13 9PL

0161 275 2725