News from the NHS R&D Forum
Mon 05 Sep 2011
News from the NHS R&D Forum
August 2011
1. News from the Forum
1.1 Accredited ResearcherTM Programme
Whether you have been in research for many years or are just starting out, the Accredited ResearcherTM Programme is an excellent way to demonstrate your grasp of Good Clinical Practice whether you’ve gained your knowledge by formal training, experience or a mixture of the two. It involves a straightforward on-line exam with 30 multi-choice questions with a pass mark of 70%. The £15 per person fee can be reduced for group purchases so if your department or organisation wishes to consider funding this for your staff please contact Angie Major at enquiries@accreditedresearcher.com for further information.
1.2 Forum Training Courses – all now open for bookings
The Forum courses will be running again the autumn:
Preparing Investigator sites and R&D Depts for GCP Inspections
Who should attend?
This course is for all clinical research professionals in the non-commercial sector working on trials subject to inspection by the Medicines and Healthcare Products Regulatory Agency (MHRA).
Course Structure
The morning session will concentrate on issues and systems at an organisational level from within the R&D department together with a practical exercise looking at the steps and inputs needed when preparing your GCP Inspection Dossier. The afternoon will drill down further to focus on issues relevant at the trial site level including the key departments of pharmacy and clinical laboratory.
Course Objectives
Upon successful completion of this course, participants should be able to:
· Explain the objectives of GCP inspections and what inspectors' will review
- Develop an action plan to prepare for Inspection
- Identify and use at least 3 positive approaches for interviews during inspections
- State 6 common inspection findings in relation to systems, Investigational Medicinal Product management and training
- Formulate corrective actions and preventative actions
Further information and online booking:
13 Oct – London http://www.rdforum.nhs.uk/004c.asp?entryid=893
9 Nov – Manchester http://www.rdforum.nhs.uk/004c.asp?entryid=895
The Inspections course has a new format and is now a full one day course with no split for an afternoon session.
Fundamentals of Clinical Research
Who should attend?
Anyone involved in the clinical research processes who is seeking to acquire the core knowledge about clinical research governance, regulations and trial management. This will include investigators, trial managers, research nurses, pharmacists, laboratory staff, R&D staff, data managers and ethics committee members.
Course Structure
This two day course considers the perspective of those staff who are new to clinical research and helps to guide them through the challenges of setting up research projects and the processes needed to ensure recruitment and safeguarding of trial subjects together with generation of robust data. Particular reference is made to both the Research Governance Framework and Good Clinical Practice legislation as described in the Medicines for Human Use (Clinical Trials) Regulations.
Some prior knowledge or experience would be helpful but is not essential since detailed materials will be provided and the course will be facilitated by experienced clinical research professionals.
Course Objectives
Upon successful completion of this course, participants will be able to:
· Identify the main governance, regulations and guidance documents which govern the practice of clinical research in the UK
· Identify and describe at least 3 principles of a Quality Research Culture
· Describe the steps required to ensure informed consent is obtained and maintained in compliance with current UK regulations
· Explain what an adverse experience is and describe the regulatory requirements for adverse experience reporting in the UK.
· Identify at least 3 obstacles to subject enrolment and propose solutions to address these.
Further details and online booking
16-17 November – London http://www.rdforum.nhs.uk/004c.asp?entryid=898
Skills for monitoring non-commercial clinical trials
Who should attend?
This two day course will provide an introduction to the skills required for monitoring clinical trials in the UK non-commercial sector.
Course Structure
The course will focus on monitoring of clinical research trials of medicinal products and is designed for all staff involved in monitoring or supervising monitoring of clinical research e.g. R&D managers, research governance staff, study coordinators and investigator site staff.
Course Objectives
Upon successful completion of this course, participants will be able to:
· Describe the purpose and processes of monitoring a clinical trial
· Identify the risks associated with conducting a clinical trial and use these to devise a monitoring plan
· Identify the key tasks involved in monitoring a clinical trial to ensure patient safety and data integrity then prioritise them in order of importance
· State at least 5 common deficiencies in relation to conduct of the trial
· Develop a monitoring report to record the findings and the agreed corrective actions
· Identify at least 3 monitoring competencies and assess their current level of performance against these
Further information and online booking:
26-27 October – London http://www.rdforum.nhs.uk/004c.asp?entryid=899
30 Nov/1 Dec – Manchester http://www.rdforum.nhs.uk/004c.asp?entryid=901
1.4 Annual Conference 2012 date & Working Group
The Annual Conference will be taking place on 28 & 29 May 2012 at Hilton Birmingham Metropole. Put this date in your diary. The programme structure will be the same as this year based on the level of experience and hopefully offering something for everyone including professional development workshops.
We now invite members to join the Working Group to plan the programme and speakers. If you would like to take part please email Angie Major (angie.major@rdforum.org.uk). The working group will hold a series of regular teleconferences in the run up to opening bookings in December.
1.5 Discussion Board
Please help answer questions raised on the Forum discussion board and share your experiences relating to R&D Management. This tool is provided to support the R&D Community and is great way to help others in R&D. You do not have to be a member of the NHS R&D Forum or set up a user account to post messages. Calls for Papers and Fellowships can be added on the Discussion Board too. Some of the recent topics include:
- Has anyone had any experience yet of producing a DSUR for the MHRA?
As a non commercial site undertaking mainly phase IV studies, this looks incredibly complicated and any thoughts or advice from colleagues would be welcome as the guidance provided is very slim with the one non commercial example being again quite complicated. - We are looking at moving to a web based R&D management system. What should we take a look at, what does everybody else use?
Log on now and post your replies: http://web.rdforum.nhs.uk/forum/forum/
2. DH/NIHR - Call for proposals
DH Policy Research Programme 
The Department of Health’s Policy Research Programme (PRP) invites research proposals in the following areas:
- Behavioural Interventions to Assist the Response to an Influenza Pandemic in the UK
- Assessment of the Feasibility of a Study into Possible Long-term Health Effects Associated with Exposure to Static and Time-varying Magnetic Fields from MRI
- An Investigation of Patient Experience of MRSA Screening
- Evaluation of the New Medicines Service
- Development of New Models for Collection and Use of Patient Experience Information in the NHS
The deadline for receipt of full applications is 5pm on Monday, 5 September 2011.
Link: DH PRP calls
NIHR SDO Programme - 11/1021: The NHS and Care Homes
This call focuses on the delivery of health services in care homes. In particular, this will focus on the generation of primary research into the organisation of NHS support for residents of the care home sector.
Applicants are asked to submit outline proposals for the above call by 1pm on Thursday 15 September 2011. Click here to find out more about this funding opportunity.
Link: Click here to find out more about this funding opportunity.
NIHR SDO Programme - 11/1022: Demand management for planned care
This call relates to research to assess initiatives to contain or manage demand for elective hospital care. The focus is on particular areas of research need that have been identified within the following three themes:
- Interventions aimed at general practitioners
- Interventions aimed at specialists and the interface
- Organisational interventions to manage or divert referrals
These themes are indicative of the wider aims and purpose of this call for proposals, and are not exclusive. Proposals for research which are not explicitly aligned with one of these areas or themes but which are consistent with the overall aims of this call for organisational research into elective care management are welcomed.
Applicants are asked to submit outline proposals for the above call by 1pm on Thursday 15 September 2011.
Link: Click here to find out more about this funding opportunity
NIHR SDO Programme - 11/1023: open call (special interest in studies with an economic/costing component)
This call focuses on the delivery of health services in care homes. In particular, this will focus on the generation of primary research into the organisation of NHS support for residents of the care home sector.
Applicants are asked to submit outline proposals for the above call by 1pm on Thursday 15 September 2011.
Link: Click here to find out more about this funding opportunity
NIHR Research Professorships Launched
Nominations are invited from Universities and NHS organisations in England for a limited number of prestigious NIHR Research Professorships. The objective of these awards is to fund leaders in the early part of their careers to lead research, to promote effective translation of research ('bench to bedside[T1] and 'campus to clinic' [T2]) and strengthen research leadership at the highest academic levels.
Up to five NIHR Research Professorships will be available in this first round.
Link: read more
NIHR Patient Safety Translational Research Centre Competition
The National Institute for Health Research (NIHR) invites applications for Patient Safety Translational Research Centres. The aim is to drive forward improvements in the domain of patient safety and safety of NHS services, pull advances in basic research, into applied research which is of relevance to patient safety, and provide a key component of the NHS contribution to our nation’s international competitiveness by making the best centres even better. The closing date for submission of pre-qualifying questionnaires by NHS/university partnerships in England that are interested in being considered for an NIHR Patient Safety Translational Research Centre is 26 September 2011 at 5:00pm.
Link: Patient Safety Translational Research Centre competition details
Devices for Dignity - unmet clinical needs competition
The Devices for Dignity (D4D) programme is offering £30,000 to fund the development of promising new healthcare technologies for the benefit of patients with long-term medical conditions. D4D has identified unmet clinical needs in two major healthcare themes: Assistive Technologies and Renal Technologies. One winner per theme will be awarded £15,000. Entrants will be given the opportunity to work with D4D’s national expert networks, resources and specialist clinicians to bridge the gap between initial concepts and securing grant funding and/or attracting early stage investment. The closing date for applications is 30 September 2011.
D4D is funded under the NIHR Invention for Innovation (i4i) programme.
Link: D4D competition
NIHR HTA Programme: Calls for proposals for commissioned research
Research proposals are sought on the following topics:
Primary Research
11/61 Relapse prevention interventions for smoking cessation
11/62 The provision of antenatal information for the NHS Newborn Bloodspot Screening Programme
11/65 Silk therapeutic clothing for childhood eczema
11/67 Long-term central venous access devices for the delivery of systemic intravenous therapy - subcutaneously tunnelled central lines versus venous access ports
11/68 Long-term central venous access devices for the delivery of systemic intravenous therapy - subcutaneously tunnelled central lines versus peripherally inserted central catheters
11/69 Psychological interventions in irritable bowel syndrome
11/71 Intensive pelvic floor muscle training to treat female urinary incontinence
11/72 Antibiotic therapy for the management of urinary tract infections in patients using intermittent self-catheterisation
Feasibility Studies
11/31 Facet-joint injections for people with persistent non-specific low back pain
11/60 Family based interventions for young people who misuse alcohol and/or other substances
11/64 Complex decongestive therapy for women with breast cancer related lymphoedema of the arm
11/66 Return to work after acquired brain injury
Mixed Methods
11/63 Clinical tools used to assess patients for hip and knee replacement
Evidence Synthesis
11/70 Therapeutic writing for people with long-term conditions
The deadline for submissions is 1pm on Thursday 06 October 2011.
Link: Click here to find out more about this funding opportunity.
3. News from other organisations
3.1 MHRA GCP Consultative Committee General Meeting
The MHRA are holding a GCP Consultative Committee General Meeting on Thursday 22 September 2011. A Forum Advisory Group member Angela Ball from The Christie will be attending. There will be a GCP Inspection questions and answers session and Forum members are invited to submit their questions to Angela Angela.Ball@christie.nhs.uk
3.2 Version 5.0 of the NRES SOPs for RECs
A revised version of the NRES Standard Operating Procedures (SOPs) for Research Ethics Committees in the UK (version 5.0) has been released on the NRES website http://www.nres.nhs.uk/news-and-publications/publications/standard-operating-procedures/.
A summary is available on the website at http://www.nres.nhs.uk/news-and-publications/news/nres-sops-version-5/. With some specific exceptions, the SOPs come into effect on 01 September 2011.
3.3 Harmonised UK-wide Edition of GAfREC
The harmonized UK-wide edition of the Governance Arrangements for Research Ethics Committees (GAfREC), which was published in May 2011, will come into effect on 01 September 2011.
Operationally, the main change from 01 September is to the remit of RECs, i.e. the requirements for ethical review under both legislation and the policy of the UK Health Departments.
To assist researchers, sponsors and R&D offices in particular in determining whether application for ethical review is required, NRES have released two documents at http://www.nres.npsa.nhs.uk/applications/approval-requirements/ethical-review-requirements/:
- A summary of the changes to the remit of RECs from the July 2001 edition
- An algorithm to determine whether REC review is required
It should be noted that there are certain types of research that no longer require review by a REC within the UK Health Departments Research Ethics Service. However, where the Research Governance Framework for Health and Social Care applies, the research will continue to require management permission from host care organisations (“R&D approval”). Within the Integrated Research Application System (IRAS), it is possible to indicate in the Filter that a research project requires review by NHS R&D only. Where a project raises potential ethical concerns, NHS organisations may require ethical review by another REC, e.g. a university REC. Most universities will require such a review as part of their normal institutional processes.
Please note that there is no need for sponsors or hosts to require confirmation that a project does not require REC review under the new GAfREC. NRES will not provide such a letter. All applicants are of course still required to contact R&D for permission to undertake this research within their organisations and if, exceptionally, review is required NRES will facilitate this.
3.4 MHRA Devices Regulatory News
The 'Red Tape Challenge' is a government initiative to reduce the burden of regulation. It enables you to comment on government regulations.
Every few weeks regulations split into themes affecting one specific sector or industry will be published on the 'Red Tape Challenge' website. All these regulations will be open for your comments.
The MHRA will be part of the ‘healthy living and social care’ theme. All the regulations for which we are responsible will be put on the 'Red Tape Challenge' website, with short explanations. This will probably take place in early 2012.
However, in the meantime, there is an opportunity now for you to let government know your views about regulatory enforcement - what works well and what doesn't, by accessing the 'Red Tape Challenge' website between 11 and 31 August 2011.
Further information can be accessed at:
http://www.mhra.gov.uk/Howweregulate/Devices/Devicesregulatorynews/CON126049
3.5 Reflection Paper - Risk based quality management in clinical trials
The aim of this paper is to describe the concept of risk based quality management in the setting of clinical research. Several related approaches have been described that focus on particular aspects of the research. The purpose of this reflection paper is to facilitate the development of a more systematic, prioritised, risk-based approach to quality management of clinical trials, to support the principles of Good Clinical Practice and to complement existing quality practices, requirements and standards.
Further information can be accessed at: http://www.hma.eu/78.html#c2694
3.6 The HTA publishes its 2010/11 Annual Review
The HTA has launched its 2010/11 Annual Review - Exercising Efficiency at its Review of the Year event on 26 July, in London
The is the HTA’s sixth Annual Review. The last year has been busier than ever and there have been major milestones and achievements along the way. The HTA hopes that this Review and the case studies included give an overview of its efficiency, effectiveness and the value for money it provides to ensure public and professional confidence.
The Annual Review covers the HTA's work from 1 April 2010 to 31 March 2011.
Further information can be accessed at:
4. Updating your membership details
We are tidying up the membership database. Please log in to your membership record and make sure your details are up to date. Go to: http://web.rdforum.nhs.uk/manage/member_details.php
There is a password reminder if you’ve forgotten or mislaid it.
Updating R&D office contact details
The NHS R&D Forum maintains the R&D office contact database on the website as a service to researchers (see Contacting R&D Offices). The R&D Forum website allows you to login and update the contact details we have for your R&D Department. If you have lost your login details or you encounter any difficulties, please contact the Forum.
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