Policies and guidelines
Here are the most current policies and guidance relating to data protection, the Human Tissue Act, clinical trials and animal research.
Good data protection management means having effective processes and methodologies in place to maintain data integrity.
- Data management guidance
- Data protection guidance
- Information security guidance
- Intellectual property policy (PDF document, 11378KB)
- Health and safety policy (PDF document, 39KB)
If you are a member of research staff at The University of Manchester, read more about data protection on StaffNet.
Human Tissue Act
All staff working with human tissue stored under the University's Human Tissue Authority (HTA) Research Licence and those who may wish to retain tissue at the end of an ethically approved research project must comply with the HTA Codes of Practice and University policies and procedures for the management of human tissue samples for research.
- UM/10/POL/HTA/002 - Policy for the Disposal of Human Tissue Samples (PDF document, 59KB)
- UM/10/POL/HTA/003 - Policy on HTA Risk Identification and Analysis (PDF document, 287KB)
- UM/10/POL/HTA/004 - Policy on Compliance with the Human Tissue Act (PDF document, 131KB)
Standard Operating Procedures and guidance documents
- UM/10/SOP/HTA005 - Disposal of Human Tissue Samples (PDF document, 279KB)
- UM/10/SOP/HTA006 - Transfer of Human Tissue Samples (PDF document, 270KB)
- UM/10/SOP/HTA007 - Document Control (PDF document, 271KB)
- UM/10/SOP/HTA008 - Management of Records (PDF document, 267KB)
- UM/10/SOP/HTA009 - Storage of Human Tissue Samples (PDF document, 271KB)
- UM/10/GD/HTA010 - Consent Guidance for the removal, storage and use of human tissue samples in research (PDF document, 325KB)
- UM/10/SOP/HTA011 - Coding/Tracking of Human Tissue Samples (PDF document, 267KB)
- UM/10/SOP/HTA012 - HTA Adverse Event/Incident Reporting (PDF document, 316KB)
- UM/10/SOP/HTA013 - Audit of Licensed Tissue Holdings (PDF document, 265KB)
- UM/10/SOP/HTA014 - Consent Recording (PDF document, 274KB)
If you are a member of research staff at The University of Manchester, read more about the Human Tissue Act on StaffNet.
All staff working on a clinical trial of an investigational medicinal product (CTIMP) must read the University Policy for Compliance with The Medicines for Human Use.
Current 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 (PDF document, 186KB)
Clinical Trials Insurance Policy
- Find out more about insurance cover for research studies involving human subjects (clinical trials).
Read our Clinical Trial Management Group (CTMG) Terms of Reference (PDF document, 124KB)
Standard Operating Procedures
Applicable, as appropriate, for CTIMP, Medical Device and other high risk studies.
- University Sponsorship of a Clinical Trial (PDF document, 159KB)
- Registration of non-University of Manchester CTIMP (PDF document, 157KB)
- Appendix I: Registration of non-University of Manchester CTIMP (Word document, 46KB)
- Assessment of Suitability of a co-Sponsor (PDF document, 127KB)
- Delegation of Responsibilities (PDF document, 177KB)
Study Setup and Conduct
- Creation and the Maintenance of a Trial Master File (PDF document, 388KB)
- Clinical Trial Authorisation (PDF document, 84KB)
- Substantial and non-Substantial Amendments (PDF document, 141KB)
- Annex I: Substantial and non-Substantial Amendments (Word document, 45KB)
- Data monitoring and Ethics Committee / Trial Steering Committee (PDF document, 339KB)
- Vendor Selection and Oversight (PDF document, 98KB)
- Clinical Trials Unit (CTU) (PDF document, 95KB)
- Computerised Systems for Clinical Trials (PDF document, 96KB)
- Data Management (PDF document, 49KB)
- IT Security and Encryption (PDF document, 48KB)
- System Level Security Policy (PDF document, 65KB)
- Case Report Form (CRF) (PDF document, 77KB)
Pharmacovigilance & Regulatory
- Pharmacovigilance - SAEs (PDF document, 207KB)
- Pharmacovigilance - DSURs (PDF document, 193KB)
- Urgent Safety Measures (PDF document, 74KB)
- Reporting a Serious Breach (PDF document, 130KB)
- Pharmacy Support for CTIMPs (PDF document, 61KB)
- Appendix 1 (PDF document, 92KB)
- Appendix 2 (PDF document, 202KB)
- Appendix 3 (PDF document, 301KB)
- Product Recall (PDF document, 126KB)
Monitoring & Audit
- Monitoring (PDF document, 108KB)
- Archiving (PDF document, 163KB)
- Publication (PDF document, 69KB)
If you have any queries elating 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
The University of Manchester
The purpose of our animal research policy (PDF document, 134KB) is to provide a clear statement about the University’s position in relation to the use of animals in research and clarify the responsibilities of those who involve animals in University activities and the key University roles in overseeing these activities.
The policy applies to all staff, students and person undertaking research that involves animals, with the intention of publishing their work under the address of the University of Manchester. The policy divides the use of animals in research into 4 categories A, B, C and D and defines the ethical review requirements for each.
- University of Manchester statement on research involving animals (PDF document , 10KB)
If you are a member of research staff at The University of Manchester, read more about animal research on StaffNet.