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RDF19 Poster Details

RDF19 Poster Detail

Poster Title 
Self-Assessment: Study Oversight Doesn’t Have to be Taxing
Abstract 

Hospital Trusts, as sponsors of research, have an obligation to demonstrate appropriate study oversight.

As research sites, under the UK Policy Framework for Health and Social Care Research, Trusts ‘remain responsible … for ensuring that the research activities are conducted in accordance with their applicable legal obligations.’

For research-active organisations with limited resource, meeting these two requirements can present a challenge. At Manchester University NHS Foundation Trust (MFT), a small team is responsible for the oversight of several hundred studies at any one time.

To meet this challenge, MFT has, for the past decade, sent out structured annual questionnaires, the Self-Assessment Exercise, to researchers.

For Trust-sponsored research, the exercise provides an element of sponsor oversight. This allows us to focus ‘in person’ visits on those projects which are considered higher risk or otherwise likely to require additional support. Returned surveys provide a level of assurance for the Trust as sponsor that studies are being well managed, whilst also flagging potential issues. Non-returns are given an in-person visit. The exercise allows the Trust, as sponsor, to access up-to-date information about its research portfolio without the need for a separate piece of work (e.g. as required in advance of the implementation of the General Data Protection Regulation (GDPR)).

For hosted interventional research, the exercise provides the Research Office with up-to-date information about project status, recruitment figures and whether a programme of sponsor monitoring is in place.

By asking about external monitoring, the exercise allows the Trust’s in-person audit programme to focus on hosted research where monitoring visits are not being conducted, ensuring an appropriate level of support for research teams.

The Self-Assessment Exercise ensures we derive the maximum amount of oversight from our limited resource.

Authors
  • SMALLEY, Paula (Research Quality Co-ordinator, Manchester University NHS Foundation Trust)
  • WEBSTER, Lynne (Head of the Research Office, Manchester University NHS Foundation Trust)
Organisation 
Manchester University NHS Foundation Trust