Category / Clinical Governance

IRAS Central Booking Service closure

Please note that the Central Booking Service (CBS; used to book in for review of “IRAS Form” applications and applications only requiring ethical review) will close at 4.30pm on Wednesday 18 December 2019 and will re-open at 9am on Thursday 2 January 2020.

If you need to book in your project for NHS REC review please take note of this Christmas closure.

Any queries please email 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 next week on Tuesday 10th December at 2:30pm until 4:00pm on Lansdowne Campus.

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

Checklist now available to support researchers undertaking clinical research

Suzy Wignall (Clinical Governance Advisor – Research Development & Support) and Juan Campos-Perez (Clinical Research Coordinator – Bournemouth University Clinical Research Unit) have compiled a checklist (PDF and word formats) that can be used to support researchers through the process of applying for and conducting clinical research.

The document contains links to various documents and further resources to guide researchers through areas such as applying for external approvals, running the study and closing the study. The checklist clearly sets out what tasks are required, the support/resources available to complete this tasks, a space to write your own notes/how this task was resolved and the date it was completed. Using this document will help you ensure that all the required tasks are completed during your research journey.

The document is also here on the Clinical Governance blog.

Remember – support and guidance is on offer at BU if you are thinking of conducting clinical research, whether in the NHS, private healthcare or social care  – contact details for Suzy and Juan are on the checklist, and you can also take a look at the Clinical Governance blog for resources and updates.

New UK Standards for Public Involvement

Involving the public in your study is important, especially at the research design stage. This is called ‘Public Involvement’ (also known as ‘PPI’ [Patient and Public Involvement]). Public involvement in research means research that is done ‘with’ or ‘by’ the public, not ‘to’, ‘about’ or ‘for’ them.

By seeking the opinions and recommendations of the public, it is a great way to ensure that your study is designed and set-up in a way that will be relevant to participants, and of good quality.
This can also help to avoid any setbacks once the project is underway.

The new UK Standards for Public Involvement have now been released and were developed over three years by a country-wide partnership between the National Institute for Health Research (NIHR), Chief Scientist Office (CSO) Scotland, Health
and Care Research Wales, and the Public Health Agency Northern Ireland

They describe what good public involvement looks like and encourage approaches and behaviours that are the hallmark of good public involvement such as flexibility, sharing and learning and respect for each other.

You can see the six UK standards and supporting materials, as well as further details about the partnership, project and the piloting of the new standards, here.

Further guidance is available via the Clinical Governance section of the Research blog and via the Health Research Authority and NIHR pages.

Introduction to Good Clinical Practice – Wednesday 15th January

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 well-being of your research participants are protected, and that the data collected are reliable.

The next GCP full day session is scheduled for Wednesday 15th January at Bournemouth University 08:45am – 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.

Checklist now available to support researchers undertaking clinical research

Suzy Wignall (Clinical Governance Advisor – Research Development & Support) and Juan Campos-Perez (Clinical Research Coordinator – Bournemouth University Clinical Research Unit) have compiled a checklist (PDF and word formats) that can be used to support researchers through the process of applying for and conducting clinical research.

The document contains links to various documents and further resources to guide researchers through areas such as applying for external approvals, running the study and closing the study. The checklist clearly sets out what tasks are required, the support/resources available to complete this tasks, a space to write your own notes/how this task was resolved and the date it was completed. Using this document will help you ensure that all the required tasks are completed during your research journey.

The document is also here on the Clinical Governance blog.

Remember – support and guidance is on offer at BU if you are thinking of conducting clinical research, whether in the NHS, private healthcare or social care  – contact details for Suzy and Juan are on the checklist, and you can also take a look at the Clinical Governance blog for resources and updates.

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.

Good Clinical Practice Refresher – Wednesday 4th December

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 Poole Hospital on Wednesday 4th December, 9:00am – 12:30pm.

Spaces are still remaining, so if you’d like to enrol, 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.

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, 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.

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.