Translational Research Storyboard Videos

Through short storyboard videos, the Translational Research Inititive provide guidance and advice on key aspects around translational research including:

  • Intellectual Property: Its Purpose & Things To Keep In Mind

  • Conducting Clinical Trials in the UK

  • Research Ethics & Regulation for research within MVLS

  • Industry Partnerships

In collaboration with the IP & Commercialisation team, the Research Regulation & Compliance team and the Industry partnerships team, these short videos provide guidance on key areas of interest, along with information on the respective teams and support mechanisms available within MVLS.

Our IP and commercialisation video discusses the importance and ways of protecting the commercially valuable outcomes of your research, as well as how IP can be used for licencing or commercial exploitation of your innovations.

Our video on clinical trials, guides researchers on how to navigate the regulatory landscape, and outlines the key processes, timelines and documentation necessary for conducting clinical trials in the UK.

Our video on Research Ethics & Regulation provides information on the University of Glasgow’s MVLS ethical requirements for non-clinical research and the process of applying to the committee for ethical review of a study.

Finally, our video on Industry Partnerships outlines the importance of engaging with the industry and external organisations to help support projects, facilitate research translation and fuel the generation of impact.

Contacts and further support can be found at the bottom of this page.

Translational Research Initiative Management Team

IP & Commercialisation Team

Research Regulation & Compliance Team

Intellectual Property: Its Purpose & Things To Keep In Mind

Intellectual Property: Its Purpose & Things To Keep In Mind

Information on the different kinds of Intellectual Property and the importance of protecting these to incentivise the investment required to develop your innovation. 

IP & Commercialisation Further Information

Link to download the IP & Commercialisation video transcript.

 

Contacts:

IP & Commercialisation Team

MVLS College Innovation Team

Translational Research Initiative

Conducting Clinical Trials in the UK

Conducting Clinical Trials in the UK

Information on the process and requirements for conducting clinical trials in the UK.

Clinical Trials Further Information

Section 1:

List of documents to apply for clinical trial authorization (CTA) from the MHRA

  1. Cover letter including the Purchase Order (PO)​;
  2. Clinical trial application form in PDF and XML versions​;
  3. Protocol document​. This is an extensive description of all aspects of the clinical trial. The topics it needs to cover are presented in the table below (Information presented in the list below);
  4. Investigator’s brochure (IB)​;
  5. Investigational medical product dossier (IMPD) or a simplified IMPD​;
  6. Summary of scientific advice obtained from the MHRA or any other regulatory authority, if available​;
  7. Manufacturer’s authorization​
  8. Content of the labelling of the investigational medicinal product (IMP) (or justification for its absence)​.

Clinical protocol​

The clinical protocol should include the following information:​

  1. Protocol Summary​;
  2. Sponsor or designated representative name and contact information​;
  3. Investigator(s) CV(s) and contact information​;
  4. Investigational Product description;
  5. Form, dosage, route, method, and frequency of administration; treatment period​;
  6. Trial objectives and purpose​;
  7. Trial design, random selection method, and blinding level​;
  8. Participant selection/withdrawal​;
  9. Participant treatment​;
  10. Summary of potential risks and known benefits to research participants​;
  11. Safety and efficacy assessments​;
  12. Adverse event reporting requirements; 
  13. Statistics and methods to track trial data​;
  14. Sponsor specifications for direct access to source data/documents;​
  15. Quality control/quality assurance procedures and practices​;
  16. Ethical considerations​;
  17. Data management and recordkeeping;​
  18. Financing and insurance details​;
  19. Publication policy​.

Section 2:

Documents for the Application for an Ethics Committee’s opinion:

  1. Application for an Ethics Committee’s opinion​;
  2. A summary of the trial, including justification, relevance, and methodology to be used;​
  3. Research hypothesis​;
  4. Statistical analysis and justification for the numbers of participants to be recruited;​
  5. Protocol​;
  6. Investigator’s brochure (IB)​​;
  7. Peer review process details​;
  8. Financial arrangements for the trial (e.g., funding sources, participant reimbursement, compensation provisions in the event of trial-related injury or death, and insurance or indemnity coverage for sponsor and investigator(s));
  9. Terms of agreement between sponsor and participating institution(s)​;
  10. Material to be used (including advertisements) to recruit potential research participants​;
  11. Informed consent form and copies of materials to be provided to participants; 
  12. Participant treatment plans​;
  13. Benefit/risk assessment for participants​​;
  14. Investigator(s) Curriculum Vitaes (CVs)​;
  15. Trial design and suitability of facilities.

Links:

Development Safety Update Reports

End of Clinical Trial Form

Contacts:

Research Regulation & Compliance team

MVLS College Innovation Team

University of Glasgow Clinical Innovation Zone

Translational Research Initiative

 

Link to download the Conducting Clinical Trials in the UK video transcript.

MVLS Research Ethics & Regulation

MVLS Research Ethics & Regulation

Information on the University of Glasgow’s MVLS ethical requirements for non-clinical research and the process of applying to the committee for ethical review of a study.

Research Ethics & Regulation further information

  1. Ethics application process and documents​ 

Application process: 

You will need a University of Glasgow email account in order to access the online application system. If you do not have access automatically, you should raise a call via the IT Helpdesk Self Service. The pathway to follow is: 

 > Request or report something 

     > Business Systems: Request Help 

         > (Category) Research Ethics System 

             > (Subcategory) Request Access 

                 > Submit Application or Supervise Student Application, as required. 

 

The Screening Form, along with the templates for all documents are available to download from the Research Ethics System, or from the MVLS committee webpages. 

 

** Make sure that you attach all of the required supporting documentation for your project, and that each document is dated, and version controlled. Lack of dates and version numbers may result in your application being returned to you without review. 

 

List of necessary documents: 

  1. Application Form 

  2. Curriculum Vitae 

  3. Participant Information Sheet* 

  1. Consent Form* 

  2. Supporting Documents – questionnaires, adverts & flyers, overseas ethical approvals (optional, depends on nature of the project) 

  3. Data Protection Impact Assessment 

  4. Privacy Notice (optional – check screening form) 

  5. Data Management Plan (optional - check screening form) 

*if not applicable, a Word document should be uploaded to the relevant slot explaining the reason. 

​ 

  1. How to create, submit, amend and withdraw applications 

The “Help” tab on the Research Ethics System homepage contains detailed guides on how to create, submit, amend and withdraw applications.  

For more information on the committee and its processes, visit:  

  1. Common decision following the ethical review of an application 

  • Approve with Minor Changes Required (this decision means that the application will only be returned to the lead reviewer for further comment once it is resubmitted by the applicant) 

  • Approve with Major Changes Required (this decision means that the application will be returned to both the reviewers and the lead reviewer for further comment once it is resubmitted by the applicant) 

  • Approve (the application is approved and can no longer be amended) 

  • Reject Application (the creator and the supervisor (where applicable) are informed of the rejection and the applicant must submit a completely new application if they wish to re-submit) 

Contacts:

Research Regulation & Compliance team

College Ethics Committee

MVLS College Innovation Team

Translational Research Initiative

 

Link to download the MVLS Research Ethics & Regulation video transcript.

Industry Partnerships

Industry Partnerships

Information on how Industry Engagement can support your research ambitions.

Industry Partnerships further information

Contacts:

MVLS College Innovation Team

Translational Research Initiative

IP & Commercialisation Team

 

Contact us with any external partnership enquiries at mvls-partnerships@glasgow.ac.uk.

 

Link to download the Industry Partnerships video transcript.

Contacts and Support