Project Setup - 2023
- Location
- Canvas module (link to module will be provided upon registration)
- Dates
- Sunday 1 January (00:00) - Sunday 31 December 2023 (00:00)
- Contact
For further information please contact CRCT
Aims and objectives:
The aim of this course is to explain the process for obtaining the necessary approvals and authorisations required before recruitment to clinical research can begin and the process for making amendments to a project.
This course will outline the procedures for setting up a clinical research project with the necessary approvals to be conducted within the University of Birmingham (UoB). This includes obtaining sponsorship, a favourable opinion from a research ethics committee (REC), Health Research Authority (HRA) approval and Medicines & Healthcare products Regulatory Agency (MHRA) authorisation and also how to make amendments.
Target audience:
You will be a researcher involved in clinical research being run at UoB, and you would like to gain a better understanding of the process for obtaining sponsorship, ethics and external approvals and amendments.
Why this course?
This course will cover the requirements for obtaining approvals and authorisations prior to recruitment to clinical research and the process for making amendments to a project.
Feedback
- Good overview of project set-up process for someone new
- Good overview of the different teams and their roles in project set-up
- This training session gives out important information and essential elements that are required for setting up a clinical research project