Clinical Research Office. A partnership between Sheffield Teaching Hospitals NHS Foundation Trust and the University of Sheffield

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Step 4 - My Study is Running

Study Recruitment

For all studies taking place at Sheffield Teaching Hospitals NHS Foundation Trust, it is mandatory that a member of the study team reports patient recruitment for their study into a web based system called Edge.

It is essential that recruitment is entered into EDGE on a real-time basis to allow accurate monitoring of recruitment. Failure to report recruitment into EDGE may result in loss or delay in funding to the Trust and the Directorate.

How to access EDGE

Once NHS Permission is issued for your study to commence at STH, please contact the Edge Local Administrator to obtain a login for EDGE. Once you have been issued with a login, please refer to the training materials below to use the system:

Please note the definition of a recruited participant is an 'eligible patient recruited onto a trial'. Screen failures do not count as recruited participants.


EDGE Local Administrator at STH: Alessia Dunn (alessia.dunn@sth.nhs.uk)

Reporting

The Principal Investigator (the local STH study lead) is required to keep the CRO informed of:

  • Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Events (SUSARs) (please refer to the SOP on Pharmacovigilance)
  • Annual reports to Research Ethics Committees and other regulatory bodies such as the MHRA, as applicable.

Please contact your R&D Coordinator for help and advice about the reporting requirements for your study.

This reporting ensures compliance with the national Research Governance Framework and complies with legal requirements for conducting research at STH NHS FT.

Amendments

Should you need to change or amend your study, please contact your R&D Coordinator to determine which approvals are required to continue with your study. All amendments require review and approval by the CRO.

Studies involving the collection of Human Tissue

All human tissue collected as part of a research study at Sheffield Teaching Hospitals NHS Foundation Trust must be collected and stored in accordance with the Human Tissue Act.

The Human Tissue Authority is the regulatory body governing compliance with the Human Tissue Act.
The Human Tissue Authority has issued Codes of Practice and the HTA website also has a useful Frequently Asked Questions document.

Contacts

For any queries regarding the use of human tissue in research please contact the STH HTA Lead Nana Theodorou (Nana.Theodorou@sth.nhs.uk 0114 2712763) or Deputy Lead Jemima Clarke (Jemima.Clarke@sth.nhs.uk 0114 2265943)

For Biorepository queries, please contact Kevin Corke (K.P.Corke@sheffield.ac.uk 0114 2712868)

University of Sheffield staff should contact Richard Hudson (R.J.Hudson@sheffield.ac.uk)

Investigators based at Sheffield Hallam University should contact the Research Support Team (researchsupport@shu.ac.uk)

Please refer to the Useful Documents section for template forms to assist with the collection and storage of human tissue for research.