Posts By / swignall

Clinical Governance Standard Operation Procedures – now live

The Standard Operating Procedures relating to Clinical Governance at BU are now live and can be found on SharePoint.

A full list of documents and links to each are provided in this table, with a link also present on the Clinical Governance blog.

If you have any queries surrounding the information present within the SOPs, or cannot access the links, please email Research Ethics.

Remember – support is on offer at BU if you are thinking of introducing your research ideas into the NHS – email the Research Ethics mailbox, and take a look at the Clinical Governance blog.

Happy reading!

Talk/session with the Wessex Clinical Research Network Study Support Service

The National Institute for Health Research (NIHR) is the nation’s largest funder of health and care research – the NIHR oversee 15 Clinical Research Networks (CRN) and these CRNs work alongside NHS Trusts, primary care providers and Universities. Each CRN has a dedicated Study Support Service.

The NIHR have a portfolio of research studies that are eligible for consideration for support from the CRN in England.  Portfolio status is usually vital to participating NHS Trusts when considering undertaking a proposed study.

Information on the NIHR portfolio is present on the research blog, but at this session our local CRN’s Study Support team will provide you with an opportunity to hear about and discuss the network and the service, and how it could benefit you.

This session is aimed at those planning on conducting clinical research.
It is also designed to raise awareness at BU about the benefits and importance of the NIHR portfolio, so if you’re just interested in learning more, please book on.

The session will take place on Tuesday 10th December at 2:3opm until 4:00pm on Lansdowne Campus.

To register your interest or if you have any queries, please get in touch with Research Ethics.

Talk/session with the Wessex Clinical Research Network Study Support Service

The National Institute for Health Research (NIHR) is the nation’s largest funder of health and care research – the NIHR oversee 15 Clinical Research Networks (CRN) and these CRNs work alongside NHS Trusts, primary care providers and Universities. Each CRN has a dedicated Study Support Service.

The NIHR have a portfolio of research studies that are eligible for consideration for support from the CRN in England.  Portfolio status is usually vital to participating NHS Trusts when considering undertaking a proposed study.

Information on the NIHR portfolio is present on the research blog, but at this session our local CRN’s Study Support team will provide you with an opportunity to hear about and discuss the network and the service, and how it could benefit you.

This session is aimed at those planning on conducting clinical research.
It is also designed to raise awareness at BU about the benefits and importance of the NIHR portfolio, so if you’re just interested in learning more, please book on.

The session will take place on Tuesday 10th December at 2:3opm until 4:00pm on Lansdowne Campus.

To register your interest or if you have any queries, please get in touch with Research Ethics.

New report highlights how NIHR support for clinical research benefits the UK economy and NHS

The National Institute for Health Research (NIHR) is the nation’s largest funder of health research and offer support to NHS Trusts, researchers, universities and any other organisation conducting clinical research.

A recent report shows that the support given by the NIHR via their Clinical Research Networks  (CRN) generated an estimated £8 billion of gross value added (GVA) to the NHS, over the last 3 years. The support also generated 47,467 full time equivalent jobs for the UK.

Other key findings from the report include:

Over the three year period (financial years) 2016/17 to 2018/19:

  • The estimated annual economic contribution of NIHR CRN supported studies increased by £0.1 billion (GVA) between 2016/17 and 2018/19 (up from £2.6 billion in financial year 2016/17, to £2.7 billion in financial year 2018/19) – linked to increased commercial contract research activity supported by the NIHR CRN  
  • For each patient recruited onto a commercially-funded trial supported by the NIHR CRN, on average NHS providers in England received an estimated £9,200 from life sciences companies, and on average saved an estimated £5,800 per patient (where trial drugs replaced the standard treatment)
  • The number of studies and patients recruited onto NIHR CRN supported studies have both increased by approximately 30% in three years (financial year 2016/17 – financial year 2018/19)

There was also a cost saving to the NHS of £28.6 million where trial drugs were provided and use in place of standard drugs.

You can view the NIHR article here and the full report here.

As taken from the article, Matt Cooper, Business Development and Marketing Director at the NIHR Clinical Research Network said:

“The benefits to the UK of a strong and productive NIHR Clinical Research Network, working in partnership with the NHS, are clearly demonstrated in this report. It describes sustained growth in the Clinical Research Network Portfolio of both clinical research and its value to the UK economy –  £2.7billion in 2018/19, an increase of £300million from the previous report in 2016.”

Remember – support is on offer at BU if you are thinking of introducing your research ideas into the NHS – email the Research Ethics mailbox, and take a look at the Clinical Governance blog.

RKEDF – Clinical Research Documentation and Filing

On Tuesday 5th November, Research Development & Support are running a 2 hour workshop on clinical research documentation and filing.

This workshop is designed to share best practice in ensuring that records are completed, stored and shared appropriately, in accordance with the ‘ALCOAC’ general principle, and Good Clinical Practice standards.

The workshop will cover the ‘essential documents’ to be kept during the research project, as well as what to do once the study has ended. Also covered will be how to ensure compliance when storing data on paper and electronically and requirements for source data.

By the end of this workshop you will have an understanding about:

  • The ‘ALCOAC’ general principle and how it applies to your research
  • What to keep in your study file
  • How to maintain good and compliant research records, throughout the life-cycle of the study
  • Requirements for once the study has ended

If you’re interested in attending then reserve your place via Organisational Development.

RKEDF – Clinical Research Documentation and Filing

On Tuesday 5th November, RDS are running a 2 hour workshop on clinical research documentation and filing.

This workshop is designed to share best practice in ensuring that records are completed, stored and shared appropriately, in accordance with the ‘ALCOAC’ general principle, and Good Clinical Practice standards.

The workshop will cover the ‘essential documents’ to be kept during the research project, as well as what to do once the study has ended. Also covered will be how to ensure compliance when storing data on paper and electronically and requirements for source data.

By the end of this workshop you will have an understanding about:

  • The ‘ALCOAC’ general principle and how it applies to your research
  • What to keep in your study file
  • How to maintain good and compliant research records, throughout the life-cycle of the study
  • Requirements for once the study has ended

If you’re interested in attending then reserve your place via Organisational Development.

Free online course! – Improving Healthcare Through Clinical Research

Interested in clinical research and what’s involved? Are you contemplating a career in healthcare or the life sciences, or, do you want to find out more about the role of clinical research in improving healthcare?

If you’ve answered yes to any of the above questions, then why not sign up to FutureLearn’s Improving Healthcare Through Clinical Research course?

The course has been developed by the University of Leeds and will be available from today, 7th October, via this link.

It is completely free and all online, lasting 4 weeks.

This course has been certified by the CPD Certification Service as conforming to continuing professional development principles. By completing the course you will have achieved 16 hours of CPD time.

Remember – support is on offer at BU if you are thinking of introducing your research ideas into the NHS – email the Research Ethics mailbox, and take a look at the Clinical Governance blog.

RKEDF – Overview of NIHR, CRNs and NIHR portfolio

On Tuesday 24th October, RDS are running a 2 hour workshop to give an overview of the National Institute for Health Research (NIHR), Clinical Research Networks and the NIHR ‘portfolio’.

This workshop is designed to raise awareness of the benefits of the NIHR’s portfolio of research studies to BU and NHS partners.  It will also explore the role of the NIHR Clinical Research Networks (CRN), with an emphasis on the set-up and work of our local network, Wessex.

The workshop will cover the requirements to be eligible for the NIHR portfolio, how to apply so that your study may be considered for adoption, and how to access the support of the NIHR CRN.

By the end of this workshop you will have an understanding about:

  • The work of the NIHR and layout of the CRNs
  • How to apply for and the requirements for portfolio adoption
  • The benefits of having a study on the NIHR portfolio

If you’re interested in attending then reserve your place via Organisational Development.

RKEDF – Good Clinical Practice ‘Lite’

On Tuesday 15th October, RDS are running a 2 hour workshop on the standards of Good Clinical Practice. If you’re running your own clinical research, or are planning to in the future then this workshop is for you.

This workshop is designed to ensure that Researchers are equipped to conduct clinical research in accordance with the international standard.

The workshop will cover other standards and regulations, roles in clinical research, participant eligibility and data collection, safety reporting and closing down your study.

By the end of this workshop you will have an understanding about:

  • The importance of protecting the rights, safety and wellbeing of research participants
  • The importance of ensuring that research data are reliable
  • The roles and responsibilities of those involved in clinical research
  • The different stages of the clinical research pathway

If you’re interested in attending then reserve your place via Organisational Development.

RKEDF – Good Clinical Practice ‘Lite’

On Tuesday 15th October, RDS are running a 2 hour workshop on the standards of Good Clinical Practice. If you’re running your own clinical research, or are planning to in the future then this workshop is for you.

This workshop is designed to ensure that Researchers are equipped to conduct clinical research in accordance with the international standard.

The workshop will cover other standards and regulations, roles in clinical research, participant eligibility and data collection, safety reporting and closing down your study.

By the end of this workshop you will have an understanding about:

  • The importance of protecting the rights, safety and wellbeing of research participants
  • The importance of ensuring that research data are reliable
  • The roles and responsibilities of those involved in clinical research
  • The different stages of the clinical research pathway

If you’re interested in attending then reserve your place via Organisational Development.

RKEDF – Overview of NIHR, CRNs and NIHR portfolio

On Tuesday 24th October, RDS are running a 2 hour workshop to give an overview of the National Institute for Health Research (NIHR), Clinical Research Networks and the NIHR ‘portfolio’.

This workshop is designed to raise awareness of the benefits of the NIHR’s portfolio of research studies to BU and NHS partners.  It will also explore the role of the NIHR Clinical Research Networks (CRN), with an emphasis on the set-up and work of our local network, Wessex.

The workshop will cover the requirements to be eligible for the NIHR portfolio, how to apply so that your study may be considered for adoption, and how to access the support of the NIHR CRN.

By the end of this workshop you will have an understanding about:

  • The work of the NIHR and layout of the CRNs
  • How to apply for and the requirements for portfolio adoption
  • The benefits of having a study on the NIHR portfolio

If you’re interested in attending then reserve your place via Organisational Development.

RKEDF – Good Clinical Practice ‘Lite’

On Tuesday 15th October, RDS are running a 2 hour workshop on the standards of Good Clinical Practice. If you’re running your own clinical research, or are planning to in the future then this workshop is for you.

This workshop is designed to ensure that Researchers are equipped to conduct clinical research in accordance with the international standard.

The workshop will cover other standards and regulations, roles in clinical research, participant eligibility and data collection, safety reporting and closing down your study.

By the end of this workshop you will have an understanding about:

  • The importance of protecting the rights, safety and wellbeing of research participants
  • The importance of ensuring that research data are reliable
  • The roles and responsibilities of those involved in clinical research
  • The different stages of the clinical research pathway

If you’re interested in attending then reserve your place via Organisational Development.

Good Clinical Practice refresher – Tuesday 8th October

Are you currently undertaking research within the NHS, and your Good Clinical Practice (GCP) training is due to expire? Or has it expired recently?

GCP certification lasts for two years, so if your training is due to expire, has expired, or you want to validate your learning, then take advantage of the upcoming refresher half day session, taking place at Royal Bournemouth Hospital on Tuesday 8th October, 8:30am – 11:30am.

Spaces are still remaining, so if you’d like to enrol, get in touch with Research Ethics.

Free online course! – Improving Healthcare Through Clinical Research

Interested in clinical research and what’s involved? Are you contemplating a career in healthcare or the life sciences, or, do you want to find out more about the role of clinical research in improving healthcare?

If you’ve answered yes to any of the above questions, then why not sign up to FutureLearn’s Improving Healthcare Through Clinical Research course?

The course has been developed by the University of Leeds and will be available from 7th October, via this link.

It is completely free and all online, lasting 4 weeks – registration now open!

This course has been certified by the CPD Certification Service as conforming to continuing professional development principles. By completing the course you will have achieved 16 hours of CPD time.

Remember – support is on offer at BU if you are thinking of introducing your research ideas into the NHS – email the Research Ethics mailbox, and take a look at the Clinical Governance blog.

Introduction to Good Clinical Practice – Thursday 10th October

Are you interested in running your own research project within the NHS? Good Clinical Practice, or ‘GCP’, is a requirement for those wishing to work on clinical research projects in a healthcare setting.

GCP is the international ethical, scientific and practical standard to which all clinical research is conducted. By undertaking GCP, you’re able to demonstrate the rights, safety and wellbeing of your research participants are protected, and that the data collected are reliable.

The next GCP full day session is scheduled for Thursday 10th October, at Dorset County Hospital, Dorchester9:00am – 4:30pm.

The day will comprise of the following sessions:

  • Introduction to research and the GCP standards;
  • Preparing to deliver your study;
  • Identifying and recruiting participants – eligibility and informed consent;
  • Data collection and ongoing study delivery;
  • Safety reporting;
  • Study closure.

If you’re interested in booking a place, please contact Research Ethics.

Remember that support is on offer at BU if you are thinking of introducing your research ideas into the NHS – email the Research Ethics mailbox, and take a look at the Clinical Governance blog.

Update to HRA’s data transparency wording for Participant Information Sheets

Following the implementation of GDPR in May of this year, the Health Research Authority released transparency wording for use in Participant Information Sheets.

The recommended wording for data transparency has been updated following consultation with various stakeholders and public involvement and feedback on the initial published wording to provide a clearer more layered approach.

The user group developed a short summary text for the Participant Information Sheet which is supplemented by a generic leaflet. The text for both is now live on the HRA website.

What information should be used in my PI Sheet?

The HRA website section is here. Click on ‘Transparency wording for all sponsors’ – this will take you to this page which contains the information to be used.

To access the text to be used in preparing the leaflet to accompany your PI Sheet, click here. If you are on the HRA website section, the text appears once you click the heading ‘Template wording for generic information document’.

What does the revision in text mean for me?

  • If you have already updated your information sheets with the previous wording, you do not need to do anything.
  • The revised wording can be uses for new studies, but the HRA will accept the previous wording if you have already submitted your application or prepared your information sheet for submission.
  • If you do wish to change your wording to the new text, please email Research Ethics so that your participating sites can be contacted.

 

If you have any queries or concerns please email Research Ethics.

Training opportunity – completing and submitting your IRAS application

Are you currently in the process of designing, setting up or planning your research study, and would like to extend your project into the NHS?

Yes? Then you may want to take advantage of this training opportunity.

Oliver Hopper (Research & Development Coordinator, Royal Bournemouth and Christchurch Hospital) and Suzy Wignall (Clinical Governance Advisor, RDS)  will be running a training session on how to use, and complete your own application within the IRAS system.

IRAS (Integrated Research Application System) is the system used to gain approvals from the NHS Research Ethics Committee and Health Research Authority, before rolling out your study to NHS Trusts. To support this, the session will include the background to research ethics and the approvals required for NHS research.

The session will also be interactive, and so as participants, you will have the opportunity to go through the form itself and complete the sections, with guidance on what the reviewers are expecting to see in your answers, and tips on how to best use the system.

The training will take place in Studland House – Lansdowne Campus, room 103, Tuesday 20th August at 09:30am – 12:30pm.

Get in touch with Research Ethics if you would like to register your interest and book a place.

NIHR-CRN podcast – Research Ethics Committees

The latest podcast from the National Institute for Health Research is available and this time concentrates on Research Ethics Committees.

All research with human participants should have appropriate ethical reflection – the podcast this month contains the thoughts and guidance of Dr Hugh Davies who is an established Research Ethics Committee Chair and former Ethics Advisor for the Health Research Authority.

If you are interested in learning more about NHS Research Ethics Committees you can view the dedicated section on the HRA website here, and even register your interest to sit as an observer at a committee meeting.

Happy listening!