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UCL Queen Square Institute of Neurology

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Regulatory and Operational Support

regulatory-operational

Study design

The LWENC CRF can work together with Investigators and/or Sponsors to assist with study design for any of the following study types:

  • Non-interventional studies (such as cohort and observational studies)
  • Interventional clinical trials (CTIMPs)
  • Medical device studies
 


statistical support

Statistical support

The CRF has a dedicated 0.2 WTE statistician able to provide advice and direct input on study design, sample size calculations, randomisation, data analysis, and publications.

The JRO at UCL also provide a biostatistics group and research support centre for investigator-led, UCL sponsored studies. For more information please visit Biostatistics Group and the Research Support Centre website.

 


LWENC pen

Study coordination

Depending on your requirements, the CRF can provide a bespoke study-specific coordination service. We work closely and collaborate with the following departments to ensure efficient study set-up:

To get your study up and running, our dedicated study coordinators can assist with the following:

  • Protocol development and other essential documents (patient information sheets, informed consent forms and GP letters etc.)
  • Costing
  • Guidance on contracts
  • Development of study specific SOPs
  • Material Transfer Agreements


Regulatory support

The LWENC CRF also provides assistance on the following:

  • REC and MHRA submissions using IRAS
  • Local Assess, Arrange, and Confirm requirements
  • Trial master file and site file set up and maintenance
  • DSURs and safety reporting
  • Protocol amendments