1. News from the Forum
1.1 Annual NHS R&D Management Forum - Prospering in the evolving NHS R&D landscape
28 & 29 May 2012 at Hilton Birmingham Metropole
300 delegates rushed their bookings through in January in order to benefit from the early bird rate with 250 of them coming to the drinks reception and dinner. There are still places available and accommodation at the Hotel. Exhibition bookings are now open and we have capacity for up to 24 stands. Sponsorship is also still available.
For the full programme, exhibitor information and online booking please see the event webpage:
1.2 Forum Training Courses
Preparing for GCP Inspections - 29 February, London
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
Fundamentals of Clinical Research - 21-22 March, Manchester
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 event is and describe the regulatory requirements for adverse event reporting in the UK.
- Identify at least 3 obstacles to subject enrolment and propose solutions to address these.
Monitoring Skills for Non-commercial clinical trials - 24-25 April, London
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
For bookings and further information on all three courses please see: http://www.rdforum.nhs.uk/004b.asp?id=for
1.3 Accredited Researcher - update
Following the launch at the 2011 Conference and subsequent uptake of the exam a review took place in December 2011. Two new sets of GCP questions will be implemented shortly and a question writing group will also start work on specialised question sets soon.
Accredited Researcher has been developed to assess and accredit researchers working in Clinical Trials in the non-commercial and commercial sectors. Anyone who is working in a GCP environment can become an Accredited Researcher. It provides a method of independent accreditation of researchers that can be used to demonstrate knowledge that has been acquired either through experience or training. Accreditation is achieved by successful completion of an online examination. The programme does not include any training, or specifically link-in with or endorse any particular course(s), but provides a way in which employers can demonstrate competency of their staff. The key principle is to move away from a notion of frequent training (sometimes inappropriate) courses to regular testing.
1.4. Annual check of R&D office contact details
We rely on people in post to keep the lists up to date so please check the details for your organisation now (see Contacting R&D Offices). The NHS R&D Forum maintains the R&D office contact database on the website as a service to researchers. 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.
2. News from DH/NIHR
2.1 Amendments to Health and Social Care Bill published
The Government has tabled a series of amendments to the Health and Social Care Bill in advance of its Report Stage in the House of Lords, which begins next week.
Health Minister Earl Howe has tabled a number of amendments that reaffirm the Government's commitment to putting patients at the heart of the NHS and handing power to GPs and nurses. Alongside the amendments, the Department of Health has also published a set of briefing notes.
The amendments include:
- Secretary of State accountability: Putting beyond doubt the Secretary of State's responsibility and accountability with respect to a comprehensive health service. These amendments follow constructive cross-party discussion about this issue.
- Greater patient involvement: Patients will have a greater say in their health, with the NHS Commissioning Board and clinical commissioning groups having stronger duties to promote patient involvement in their own care.
- Education and training: The NHS Commissioning Board and clinical commissioning groups will have new responsibilities to support education and training, strengthening the links between workforce planning and education and training.
- Health inequalities: A new duty on the Secretary of State, NHS Commissioning Board and clinical commissioning groups to report annually on their progress in tackling health inequalities.
- Strengthening integration: Making clear that the health regulator Monitor will have the power to require healthcare providers to promote integration of NHS services.
See amendments and briefing notes.
2.2 Framework agreement for NHS Commissioning Board Authority in place
The Department of Health and the NHS Commissioning Board Authority have jointly signed a framework agreement that sets out the relationship between the two organisations.
The agreement covers roles and responsibilities and lines of accountability, and describes how the Department and the Authority will work together.
See Framework Agreement between the Department of Health and the NHS Commissioning Board Authority
See Annex A: Wider guidance
See Annex B: Finance and accounting responsibilities and delegated authorities
See Annex C: Public and Parliamentary Accountability
See Annex D: Communications
In future the Department will have framework agreements with each of its arm's length bodies (ALBs). Framework agreements describe each organisation's roles and responsibilities and the lines of accountability between the Department and the ALB.
They focus on how the Department and the ALB will work together to support the successful delivery of policy intentions and objectives, and are part of a suite of documents that describe the governance arrangements for that ALB.
2.3 New NIHR Research Capability Funding announced
From April 2012, NIHR Research Capability Funding will replace Flexibility and Sustainability Funding. The new Research Capability Funding provides funding to research-active NHS organisations to enable them to maintain research capacity and capability.
The main changes are:
Widening permitted uses of Trust and Network RCF to allow some contribution towards sponsorship and governance costs and 'overheads' associated with Trusts hosting research (this will be carefully defined for each RCF stream).
Enabling Trusts that recruit significant numbers of patients each year, who do not receive enough NIHR funding to trigger Trust RCF, to qualify for a fixed basal amount of RCF.
Allowing Trust RCF to contribute towards maternity, paternity and long term sick-leave costs.
Simplifying the rules for Network RCF so that permitted uses follow those allowed for core funding, and to avoid funds being diverted into supporting the conduct of the research itself.
2.4 Calls for Proposals
The latest Calls for Proposals can be viewed at:
3. News from other organisations
3.1 New MHRA website home page
The MHRA are pleased to announce the launch of a brand new home page for their website www.mhra.gov.uk which went live on Saturday 07 January 2012.
The new home page presents all of their latest information, including their safety updates, in a clear, user-friendly fashion. There are clear ways to navigate to whatever information you need from the website and links to browse through sections.
The development of the new home page has been based on their user feedback, including the website survey they carried out over the summer.
They would welcome your feedback on the new home page. If you have any comments please email firstname.lastname@example.org
3.2 Call for UK Clinical Research Collaboration (UKCRC) Clinical Trials Unit Registration
The UK Clinical Research Collaboration (UKCRC) Registered Clinical Trials Units (CTU) Network is inviting applications from both new and previously registered Units to register with the UKCRC. The registration is intended to help improve the quality of available expertise to carry out clinical trials in the UK. Leading the review is an International Panel of leading world experts in clinical trials.
To be eligible to apply, Units have to demonstrate they are capable of centrally coordinating multi-centre clinical trials and other well designed studies. This includes showing appropriate expertise in the design, conduct, data management, publicity, analysis and reporting of a study.
3.3 Invitation to comment on new MRC guidance on good research practice
The MRC is currently revising the principles and guidelines on good research practice and we would welcome views on the new draft which has been developed by a working group of the MRC's Ethics, Regulation and Public Involvement Committee (ERPIC).
Good research practice underpins high-quality science and supports the robust evidence base needed to drive improvements in health and this new draft sets out our expectations for all MRC-funded researchers in the form of high-level principles alongside guidelines providing further information and sign-posting to more detailed guidance and codes of practice.
The MRC would particularly welcome views on the whether the new principles and guidelines provide the right level of information and are clear and comprehensive, as well as views on any gaps you feel need to be addressed either here or which might form the basis for future work in this area.
The new principles and guidelines will be available primarily as a web based resource, with links to the relevant policy and guidance documents accessible in each section. It will also be available as a document that can be downloaded from our website, along with a summary flyer based on the key principles. An induction checklist, which also provides key links, will be produced for MRC units and institutes.
MRC's aim is to complete this review and to issue the new principles and guidance in the spring. Any comments on the current draft should be sent to Rosa Parker, Corporate Information and Policy Manager, to email@example.com by Monday 13th February 2012.
For reference the current version of this publication is available here.
Further information: http://www.mrc.ac.uk/Newspublications/News/MRC008445
3.4 A National Strategy to improve recruitment into Surgical Research studies
The National Working Party GRIST (Growing Recruitment into Interventional and Surgical Trials), under the Chairmanship of Professor Dion Morton, initiated a one year scheme to support specialist surgical research nurses which was jointly-funded by the NIHR CCRN (through the then national contingency) and the Bowel Disease Research Foundation (BDRF). £3.5k was provided to 16 surgical units across the UK and this resulted in the recruitment of over an additional 100 patients (a full report is available on request). Given that surgical trials are complex and that patient recruitment into such trials has particular challenges, recruiting over 100 patients at an average cost of circa £560 each represented a considerable achievement and demonstrated how targeting funding in this way can be very effective.
This scheme is being extended for a further round and funding to 7 centres has been agreed with support being provided to each centre from the CCRN 2011-12 underspend (to be spent by 31 March 2012) and matched by the BDRF for 2012-13, CLRNs which have a centre will be notified shortly.
GRIST is very keen to extend this successful scheme to other areas of surgical research and has received a number of proposals for targeted support to improve recruitment into Head and Neck surgical studies. These proposals have been carefully considered by GRIST and a number have been strongly endorsed. We will be forwarding the details of these to the relevant CLRNs and would ask that management teams discuss each request with the applicant and, provided that they are supportive of the case made, prioritise the funding of very modest amounts of support which will make a significant difference nationally and support increased rates of recruitment for the CLRN which will of course feed through to next year's ABF allocations.
If you would like to discuss any aspect of this, please contact Jonathan Gower, Assistant Director (Comprehensive Clinical Research Network), firstname.lastname@example.org.
3.5 MRC Calls for Proposals
The latest Calls for Proposals can be viewed at: