Clinical Trials
University of Birmingham sponsorship of clinical trials is conditional on trials being run according to the university's quality management systems. Read the Information on these and the University's Standard Operating Procedure for the management of clinical trials.
Clinical Trials of Investigatory Medicinal Products (CTIMPs) must be run in accordance with the university's Standard Operating Procedure and are subject to substantial oversight.
Investigators considering running a clinical trial are encouraged to do so through one of the University's three Clinical Trials Units:
The university does support a small number of CTIMPs which are not managed by a Clinical Trials Unit, but the resources available to support this kind of activity are limited and you should contact the Research Governance Team as early as possible to find out whether the project can be supported. You should be aware that where a CTU is not supporting a study it may take some time for the Research Governance Team to process CTIMP applications.
Aside from the governance team's resources, this document (link) tabulates the criteria that the Governance Team will check in order to establish whether or not the university can sponsor a clinical trial. As part of the study set up process Independent CIs will be required to meet with the University\'s Quality Manager, and the Sponsor Support Team will also pay regular visits to the study team through the course of the study.
For information, this video provides a description of the function of CTUs and the value of collaborating with a CTU. This provides an example of the function of CTUs in developing an NIHR funding application
http://www.nihr.ac.uk/newsroom/the-role-of-clinical-trials-units-in-developing-an-nihr-funding-application/3304
Information for existing CIs of CTIMPs
The following documents are provided here as an easy place to access university documents:
- University Standard Operating procedure for clinical trials (link). This document details the steps that you are required to go through to run a University of Birmingham clinical trial. It is also a useful resource describing how all the different teams involved in clinical trial delivery interact.
- Delegated Trial Duties:(link) This document is the form UoB CIs sign when undertaking a CTIMP and lists all the trial duties that independent CIs have delegated to them by the University of Birmingham. If you are the CI on a University of Birmingham CTIMP then it is essential that you read and understand this document.
- DSUR Template: (link). The University of Birmingham delegates the responsibility for submission of Development Safety Update Report (DSUR) to the Chief Investigators on CTIMPs. This report must be completed annually and submitted within 60 days of the anniversary of the Clinical Trial Authorisation.
- Essential Document Checklist: (link)This document lists the documents that must be kept for a CTIMP, listing what should be kept on the trial master file at site, and what should be sent to the Research Governance team.
- IMP listings for University of Birmingham Sponsored Studies (IMP-Listings). This document lists IMPs utilised in UoB Sponsored Clinical Trials. It is a resource for CIs wishing to identify other trials using the same IMP, for example in order to prepare a DSUR.
- University Statement on use of University of Birmingham as a site in regulated clinical trials. Please note that the University of Birmingham would not normally act as a ‘site’ for regulated clinical trials or surgery trials (i.e. Clinical Trials of Investigatory Medicinal Products (CTIMPs) or of medical devices).