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:

• EDGE Full Training Manual

• EDGE Recruitment Quick Guide

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: Jenny Powell (jenny.powell1@nhs.net)

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.

Reporting to Researchfish

Researchfish is an online platform used to measure the impact of outcomes arising from research awards from a variety of funders including the National Institute for Health Research, Cancer Research UK, British Lung Foundation and Research Councils.

If you are a Principal Investigator who holds a grant award from a funder that uses Researchfish, you are required to report the research outcomes from this award on an annual basis. For the NIHR, this also includes Senior Investigator awards. You can see how funders like the NIHR use the information reported by researchers here.

You can input updates into Researchfish all year round, however, there is generally an annual submission window with a deadline by which a Principal Investigator must submit the data to Researchfish.

Submissions are required for five years after the award has ended.

If a return is not submitted by the deadline, funders can apply sanctions to the Principal Investigator (eg: being ineligible to apply for future funding) or to the organisation (eg: grant payments to Sheffield Teaching Hospitals NHS Foundation Trust are withheld).

You can find answers to commonly asked questions here. 

An overview of the common outcome types used in Researchfish can be found here.

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 Jemima Clarke (Jemima.Clarke2@nhs.net 0114 2265943)

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