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Key Documents & Useful Links
Key Documents
We operate a VALID APPLICATION process . We will review each project only upon receipt of all documents required. This enables us to guarantee a quick turnaround time (review and sign off within 25 days of reciept of your valid application) so you can plan the start of your project eg initiation dates, investigator meetings, patient recruitement timescales, more efficiently.
Sponsor Declaration - Confirmation by the Sponsor before submitting your REC application
The REC require confirmation from the Sponsor before accepting your application.
If you book the application
with NRES before notifying the R&D, you run the risk of missing
your ethics committee slot. It is the Chief investigator's responsibility
to allow sufficient time for R&D Approval before the deadlines required
for Research Ethics review.
All CTIMP’s should continue to be submitted as early as possible to the R&D QA team to ensure timely sign off prior to REC review.
| R&D
Approval Guidance |
What documents do I need to send? |
| Support
Department Requirements |
R&D
Costing |
Radiology - Guidance for Researchers |
|
Pharmacy - Application
Form |
|
Pathology - Application
Form |
LTHT R&D Related Policies
LTHT Key R&D Documents & Guidance Notes
General R&D Websites
The official Department of Health Research & Development website. The site contains details of national R&D policy and national
R&D Programmes.
National Institute for Health Research - (NIHR)
UK Clinical Research Collaboration
The UK Clinical Research Collaboration ( UKCRC ) is a partnership of organisations working to establish the UK as a world leader in clinical research, by harnessing the power of the NHS . Our aim is to re-engineer the environment in which clinical research is conducted in the UK, to benefit the public and patients by improving national health and increasing national wealth.
The UK Clinical Research Network (UKCRN) was established to provide support for clinical research and to facilitate the conduct of randomised prospective trials and other well-designed studies. It is tasked with developing a world class infrastructure to support clinical research in the UK.
NRES - National Research Ethics Service
The Central Office for Research Ethics Committees' website providing people with access to comprehensive information on the research ethics committee system in the UK
Click here for an easy read summary of the Mental Capacity Act produced by the Department of Health
Patient & Public Involvement in Research
For guidance on how to involve patients and the public in research and further information on the work of Involve
National Electronic Library for Health
Providing a digital library for NHS staff, patients and the public.
Centre for Reviews and Dissemination
CRD undertakes reviews of research about the effects of interventions used in health and social care. The centre maintains various databases, provides an enquiry service and disseminates results of research to NHS decision makers.
United Kingdom Cochrane Centre
The UKCC facilitates and co-ordinates reviews, primarily in the specialised area of randomised controlled trials (RCTs).
MedIPeX - Regional Innovation Centre
MedIPeX is the NHS regional innovation centre for Yorkshire and the Humber region. It is one of a national network of NHS innovation hubs that manage and exploit intellectual property in the NHS
Clinical Trials Websites
Clinical
Trials Research Unit
The Clinical Trials Research Unit at the University of Leeds is a leader in
the field of clinical trials. The Unit conducts large scale national and international
randomised clinical trials in a variety of clinical fields (cancer, women
and child health, cardiovascular
disease, care of the elderly, mental health) and has an associated research
portfolio
Medicines
and Healthcare products Regulatory Agency (MHRA)
The executive agency of the Department of Health protecting and promoting
public health and patient safety by ensuring that medicines, healthcare products
and medical equipment meet appropriate standards of safety, quality, performance
and effectiveness, and are used safely.
Written authorisation must be obtained from the Sponsor before applying to the MHRA.
MRC/DH Clinical Trials Toolkit
The site for practical help when trying to meet the requirements of the UK Medicines for Human Use (Clinical Trials) Regulations 2004.The site has been developed primarily for clinical trialists and R&D managers working in the academic sector, but will also be of use to other health professionals.
Is
it a Clinical Trial of an Investigational Medicinal Product ? 
This algorithm and
its endnotes will help you answer that question.
European
Clinical Trials Database
This site enables you to
apply for a EudraCT number for your clinical trial.
Association
of British Pharmaceutical Industry
This site provides further
information on the ABPI, its work and publications.
The UK Good Laboratory Practice Monitoring Authority (UK GLP MA)
This
site provides information on the structure and activities of the UK GLP MA
Funding & Research Support Websites
A website of digest of health-related research funding opportunities, training courses and advice services for all health and social care staff.
This is a national DH programme of research that aims to ensure that high quality research about the cost, effectiveness and broader impact of health technologies is produced in the most effective way for people who use, manage and provide care in the NHS.
Service Delivery & Organisation
The NHS Service Delivery and Organisation (SDO) Programme is a national research programme that has been established to consolidate and develop the evidence base on the organisation, management and delivery of health care services.
New & Emerging Applications of Technology
New & Emerging Applications of Technology (NEAT) is one of the three main national programmes funded by the DH. NEAT fills a perceived funding gap by supporting work which applies recent advances in fundamental knowledge and technology to the development of new products and interventions for improved health and social care or for disease prevention and treatment.