Newcastle Clinical Trials Unit

Conduct

Conduct

We support the conduct of trials through trial management, quality systems, randomisation and clinical data management.

Trial management

All aspects of trial management are provided. Including:

  • study setup (including protocol and database development, study registration, HRA and regulatory applications, Trial Master File setup and study launch)
  • active recruitment and follow-up (including site monitoring and support, randomisation, safety reporting and oversight committee coordination)
  • close-down (including site closedown, coordination of final reports, registry updates and archiving)

Quality systems

Quality is a core component of NCTU activities and is supported by our dedicated Quality Assurance Team. This is underpinned by a comprehensive suite ot Standard Operating Procedures covering essential aspects of trial and data management and statistical analysis.

Randomisation

Where randomisation is required per study design, NTCU offers a regulation-compliant web-based system which is accessible 24 hours per day, 7 days per week. The randomisation system is set up and supported by NCTU with a helpline available Monday - Friday 0900 to 1700 hours (excluding bank holidays and University closure periods).

If you are currently experiencing any problems, please e-mail nctu.database.support@newcastle.ac.uk or telephone 0191 208 8211.

Clinical data management system

NCTU provides access to an FDA 21 CFR part 11 and good Clinical Practice-compliant electronic data capture system (MACRO).  This is a web-based system which is available 24 hours a day and is accessible directly by research sites, facilitating efficient and timely data qcquisition.  MACRO has been validated work with Internet Explorer 10 and 11 and Firefox 45ESR.  Please note that since January 2016 Microsoft no longer supports Internet Explorer versions 7, 8, 9. If you currently use one of these versions please upgrade before 2017.

Click here to log into MACRO.