What is ICH GCP?

The Good Clinical Practice (GCP) guidelines developed by the International Conference on Harmonisation (ICH) provide an international ethical and scientific quality standard for the design, conduct, recording and reporting of research involving human subjects.

While these guidelines primarily relate to the conduct of clinical trials of Investigational Medicinal Products (ctIMPs), they are equally relevant and applicable to the conduct of all research.

Why is ICH GCP important?

The primary aim of the guidelines is to safeguard the rights, safety, well-being and dignity of all research subjects. However, research that is conducted to GCP standards will be regarded as reputable and will assist in publication and international recognition of the research in the research community.

Do I need ICH GCP training?

If you are a Chief (CI) or Principal Investigator (PI) or a member of a research team that will be conducting a ctIMP, then ICH GCP training is a legal requirement.

How do I get ICH GCP training?

There are two options available:

• Check the ICH GCP training dates page for a list of training sessions (courses run by NBT are free to attend subject to eligibility).
• Contact the R&I office to book a place on a training session.

If you are due to take part an NIHR Portfolio-adopted project, you will be eligible to book a free place on the UKCRN ICH GCP training events. Details of these events are available online via NIHR Events.

‘Good Clinical Practice (GCP) for new and experienced staff’ provides information on regulations, serious breaches & safety reporting. ‘Essentials for new clinical research staff’ provides a useful introduction to essential documents, trial phases and the conduct of a study.

Approximately 9,000 patients in the UK develop primary brain cancer, but there are many more who develop secondary cancer within the brain from different primary sites around the body (such as breast and lung).

The brain tumour unit at North Bristol Trust treats over 400 cases of primary brain and spinal cord tumours per year.

Brain cancer affects both adults and children, and in children it is the second highest cause of death after accidents.

One of the major problems with primary brain cancer is that it invades the brain widely as single cells and therefore can be difficult to completely remove by surgery. It also can develop resistance to traditional chemotherapy and therefore tumour relapse is common.

Future developments of brain cancer will involve fully understanding each individual’s tumour according to what is driving the abnormal growth of that specific tumour. Then surgery and a range of therapies can be tailored to the individual, providing a personalised medicine approach.

Dr Kathreena Kurian, Consultant Neuropathologist, talks about her vision for being a centre of excellence for predicting brain tumours in patients:

Video Transcript:

My name is Kathreena Kurian, I'm a Consultant Neuropathologist, so that means for a living I diagnose brain tumours.

The problem in this country is clear. We have nine thousand adults with a tumour starting within the brain, and about 1,500 children. And the problem is, after five years only 20% of those patients are alive, so we need to do better for these patients.

The other thing is that now patients are surviving tumours from elsewhere in the body, so breast and lung tumours for example which are travelling to the brain which is obviously devastating. So Bristol is a huge centre for treating brain tumour patients. We have neurosurgeons here, we have academics, and our ambition is to have the Bristol Brain Cancer Centre of excellence, which I will lead.

We have a research group here, and the main focus is to find out why you have a brain tumour in the first place. At the moment why you get a brain tumour is not very well known. There aren't any good risk factors apart from if you've had previous radiotherapy or in very rare genetic cases. So we need to find out why you have one in the first place so we can try and prevent it.

The other thing I know is that when I diagnose two patients, give them the same diagnosis, they can behave very very differently with the treatments that we give them. So what we want to understand is how one patient's tumour is different from another, and can we personalise the therapies for these patients.

Because at the moment if you have a brain tumour, we take it out using neurosurgery, and then we give you chemo radiotherapy, which is obviously very difficult to take. And what happens is although the chemoradiotherapy kills most of the tumour cells, it leaves some cells behind and what normally happens is this tumour regrows, that's what happens to practically all of our patients.

Now there is a new generation of targeted inhibitors which can be specific to an individual tumour. So what we want to do is match an individual patient with a targeted therapy, so so-called personalised medicine, and that's our aim for brain tumours, and I'm sure it will revolutionise the outcome for this group of patients who, at the moment, have a very poor outcome.

The Breastcare Centre at NBT offers patients, and people at risk of developing breast cancer, excellent patient centred care and the opportunity to participate in research.

The centre has had a successful research team in place for a number of years delivering complex interventional studies.

Dr Lynn Jones, Consultant Radiologist, talks further about the work of the team:

Video Transcript:

I'm Dr. Lynn Jones and I'm a Consultant Radiologist at the Bristol Breast Care Centre at Southmead Hospital.

My clinical work is quite varied. I see patients in clinic when they've been referred to us, perhaps because they found a lump in their breast and they're concerned that it might be a breast cancer. So I'm one of the doctors who does an ultrasound of the breast and then goes on to do a biopsy of the lump using local anaesthetic and ultrasound guidance.

I also work behind the scenes in a room like this, interpreting mammograms and other more complex imaging tests. And in addition, I work for the National Health Service Breast Screening Program in a similar role.

The Breast Screening Program was set up to detect cancers early while they're still small and they can't yet be felt. And this is because we know that finding breast cancer early can save lives. The research that I'm leading here at North Bristol is trying to find a way to improve cancer detection for breast cancer. And my particular interest is in an imaging test called Fast MRI.

Fast MRI is a magnetic resonance imaging or MRI scan, and we want to see whether Fast MRI can be used as a screening test for some groups of women because it's much quicker than full breast MRI, and we think it will be less unpleasant as a test to have.

A lot of the preparation for this research has involved a great deal of talking to our patients and to members of the public, and this has been very useful indeed. Because we're very lucky here to have a local charity called BUST, and so they seemed like a sensible place to start, and so I asked them how they had experienced breast MRI and what they thought of it, and I was really quite surprised and shocked that many of them had found it a very unpleasant experience.

So since then we've been working together to try to improve that experience for other women in the future. So we've made a short film of what it's like to have a breast MRI, and the film is now available to watch on the North Bristol Trust website. And we've also updated our information leaflet to include a section written by our Clinical Psychologists on how to cope with having a breast MRI, so that while you're having it you can focus and manage to complete it to the end of the test.

So once we’d done all that work with BUST, we then had a whole series of formal public consultation where we consulted members of the public about our research and how they felt it should be designed. And we've also recruited two members of the public to be on the committee that decides the direction that the research is going, and what its priorities should be.

So overall I've really been astounded that this whole consultation process… people are just so keen to be helpful, and so kind to us, and willing to give their time and, actually, it's been a great benefit, not just for our research study, but I've also learned an awful lot about our service in general, and I think that it's helped us to be able to improve that service for our patients and our clients.

We diagnose over 3,000 new cases of cancer and treat approximately 5000 new and recurrent cancers each year, making us one of largest cancer centres in the South West.

The clinical trials team at North Bristol NHS Trust co-ordinates and support the delivery of clinical trials across a variety of cancers including, Haematology, Urology, Brain, Head & Neck, Upper Gastro Intestinal, Colorectal, Breast, Lung & Skin cancer.

 North Bristol NHS Trust was designated a Myeloma UK Clinical Service Excellence Programme, for a second time in 2023, in its recognition of our outstanding care to patients with myeloma.

North Bristol NHS Trust is home to an established Dementia Care Team with nursing and training leads supporting patients with Dementia.

In Bristol there are an estimated 4,500 people living with the condition. Over the next 30 years, we expect that number to increase by a third.

In partnership with the University of Bristol, the Bristol Brain Centre at was opened in 2015 at NBT. It currently accommodates clinical research into dementia, multiple sclerosis and Parkinson’s Disease.

Its research spans lifestyle modifications, techniques to improve early diagnosis, medications that might enhance quality of life as well as those that might slow down, halt or even prevent dementia. The centre has close working links with University of Bristol’s Dementia Research Group and other neighbouring universities. It also runs a cognitive clinic, specialising in early onset or rarer forms of dementia, and is expected to provide a home for clinical research into dementia until at least 2035.

Here Dr Liz Coulthard expands on the vital research her team conduct at North Bristol NHS Trust:

Video Transcript

Hello, my name is Liz Coulthard, I am a Neurologist and I specialise in Dementia and Huntington's disease.

We run a clinical service here in the Bristol Brain Centre in Southmead Hospital. I see patients with Dementia, the commonest type being Alzheimer's, but also with all different types of other dementias, including very rare types, and I also run a Huntington's disease clinic.

One of the critical things about our service is that we place research at the heart of the service. So, when we see a patient, we always think what is best for this patient clinically, what can I do for them, but one of the other things that we think is what opportunities are there for this patient to take part in research if they want to.

So some of the research we do aims to find a treatment that will slow the progression of dementia such as Alzheimer's disease. Some of these trials are international trials, and some of them are run by commercial companies. Other trials are academic and because I work for the University we are leading a trial called the RADAR trial, where we're giving a drug to people to see if we can slow the progression of Alzheimer's and there are around 20 sites around the UK taking part in this trial.

Some of the other research that we do aims to understand a bit more about how dementia affects the brain. One of the aims of this is to try and see if you can diagnose dementia a bit earlier than it’s currently diagnosed because we think maybe we'll have to treat dementia earlier in the course of the illness to have a beneficial impact on people.

So at the moment not only do we recruit people who have dementia, we also recruit people who are diagnosed with a pre-dementia state mild cognitive impairment. We know that some people with mild cognitive impairment will develop Alzheimer’s disease, but some won't, and one of the areas of our research is to identify people at this early stage who might be those that are destined to go on to get dementia so that we can offer them treatments.

We recruit people with dementia but also we recruit healthy older people who may in the future develop dementia, and it's really important that we have these recruits, because these are the people where we may actually be able to alter things more.

So we're very keen for people to take part in our research, and it might involve a brain scan such as an MRI or it might involve some memory tests or it might involve sometimes things like EEG (so brainwave recording) but we always talk people through so they know exactly what to expect and then they let us whether or not they want to take part.

The Trust’s research group in antimicrobial chemotherapy (BCARE) have a track record spanning 45 years of excellence and international and national leadership in antibacterial therapeutics.

In recent years this has expanded to encompass the impact of diagnostics on clinical outcomes. The Group have numerous links to commercial funders and an extensive international network of research collaborators.

Based in the Bristol Brain Centre, the Movement Disorders Research and Clinical Team, including the Deep Brain Stimulation (DBS) and Parkinson’s Disease Advanced Therapy teams, allows for a fully integrated approach to providing clinical care and offering opportunities for patients to participate in research.

The Movement Disorders team work closely on a number of regional, national and international research studies, and are developing a mixed portfolio of studies that will collectively address knowledge gaps in Parkinson’s Disease and other Movement Disorders.

Here Dr Alan Whone discusses his role as the Clinical Lead for Movement Disorders Research at North Bristol Trust:

Video Transcript:

So my name is Alan, and my surname is Whone, and I’m a Neurologist here at North Bristol NHS Trust. My interest is in Movement Disorders which is the branch of Neurology that includes Parkinson’s Disease, but also includes problems like Tremor and a condition called Dystonia.

In terms of my clinical practice, I tend to see patients from across the South West of England, South Wales and Southern Ireland, particularly patients coming with complex stage Parkinson’s, and we offer here at the Bristol Brain Centre advanced therapies for those disorders.

But a third of my week is spent doing research, and my research really falls into two main arms. One arm is trying to address symptoms that are not currently tackled by the available armoury of medication. So, for example, in Parkinson’s we’ve got things that improve tremor, and stiffness and slowness, but we did not have anything to improve falls. So, a few years ago, to try and improve falls, we attempted to reposition a drug that’s used for Dementia because, for various reasons, we thought this might help patients with Parkinson’s without Dementia to reduce their falls. And what we found was that, compared against placebo, falls went down by around 40%. This then is going onto a larger study, because you have to replicate that in greater numbers and at multiple centres, and that’s being led by the Department of Social Medicine at the University of Bristol and Emily Henderson, who’s a geriatrician. And, if that comes through, this will really bring for the first time a therapy to clinic to reduce falls in people with Parkinson’s.

The other side that’s really needed by people with Parkinson’s is something to slow the progression down. So, we’ve got treatments that address symptoms some of the time, but nothing to restore brain cells or so-called neuro-restorative therapy, or to protect brain cells and therefore progression. So, year on year, sadly people with Parkinson’s continue to deteriorate. Here at the Bristol Brain Centre, over the last five years, we’ve been trailing a protein called GDNF, where we’ve been infusing that, with Professor Gill and the Surgical Team, into the brain with people with Parkinson’s on a monthly basis to see if that protects brain cells. And that data is in, and there are some trends for benefit, and we now wish to explore that further. So, what we’re trying to do is have a panel of things that address some of the unmet symptom needs and the unmet need for neuro-protection, and this is really exciting because this is research that could have an impact not only here in Bristol but across the world.

The Avon Orthopaedic Centre, based at North Bristol NHS Trust, has a long history of being one of the leading centres in the country for research and innovation in orthopaedic care.

The Bristol University Musculoskeletal research team are also based within the site, with this partnership enabling clinicians and researchers to closely collaborate both locally and internationally to deliver high quality research based on our multidisciplinary expertise.

Our Neurosciences Department is world leading in a number of clinical and research specialities include stroke, dementia, Parkinson’s disease, multiple sclerosis and Huntington’s disease.

They work with National Institute for Health Research (NIHR) networks to deliver research excellence for patients with complex and varied needs.

North Bristol NHS Trust is a centre of excellence for the delivery of care for people with renal impairment. We are also home to the main kidney transplant centre in the South West.

Our experienced research team works collaboratively with a number of other research teams including diabetes and cancer to deliver cross-functional complex studies in addition to studies focused solely within the renal service.

With over 15 years of commercial and non-commercial research, our Respiratory Research team, led by Professor Maskell, is one of the largest and most successful clinical and academic pleural research teams in the UK.

For nearly a decade they have been designing and delivering practice-changing clinic trials, improving the lives of patients with mesothelioma, pleural infection, and pneumothorax.

They have tested new devices designed to manage recurrent pleural effusions and pneumothorax, including a first in human trial which led to an international multi-centre randomised controlled trial (SEAL-MPE).

The multidisciplinary team includes highly skilled and motivated research nurses, managers, clinical research fellows and clinical academics. The team has also successfully been awarded research grants of more than £5 million.

The Bristol Speech & Language Therapy Research Unit (BSLTRU) conducts research and development that aims to improve the care and management of people with speech, language and communication disorders by developing knowledge related to the prevention, management and social consequences of the disorders.

The Unit is hosted by North Bristol NHS Trust and is situated in the grounds of Southmead Hospital, Bristol. The team consists of speech & language therapy, psychology and information systems researchers with specialisms in primary language delays, speech impairments, aphasiology and stuttering as well as administrative and technical support.

More information about the department can be found on the BSLTRU Research Hub.

A vital branch of our Acute Care Department, the Stroke Clinical Research Team deliver national and international multi-centre studies in Stroke and related specialities, working to advance the care that we give to our patients.

The team also work closely with colleagues across the Trust and beyond to develop new and innovative research ideas that test new treatments especially in the field of stroke.

Video Transcript:

Thank you so much for supporting Stroke Research here at Southmead.

At the moment we're only a very small group but, with your support, we'll grow and become a thriving stroke research network to support people after stroke, and prevent stroke, and improve people's outcomes when they have a stroke.

My own passion is for visual loss after stroke. Many people don't realise that a stroke can cause visual loss, but it's very common, affecting tens of thousands of people in the UK every year, and it can be very disabling.

At the moment we're working on new treatments, including Stroke rehabilitation to improve people's quality of life when they've been affected by visual loss.

In the Stroke research group we're also working in other areas including thrombectomy or clot extraction after stroke, using brain imaging to increase the number of people who are eligible for emergency stroke treatment.

We're working on stroke genetics research, and also we're individualising blood-thinning treatment to prevent a stroke.

So thank you once again for supporting stroke research here at Southmead.

The Trauma Research team undertake commercial and non-commercial, national and international, device and ctIMP studies.

An integral part of South West Regional Trauma Centre based at NBT, this highly skilled team are able to include patients in the crucial early phases post traumatic injury in a sensitive and caring manner.

Having delivered clinical excellence and research innovation working collaboratively with both drug and device companies, the North Bristol NHS Trust Urology Department now delivers the clinical service for the whole Bristol area increasing both our clinical and research potential.

The department has an enviable position focussing world leading clinicians, dedicated research staff and a patient population invested in the development of future treatment options.

Working with Bristol Health Partners the Urology Research Team have also created a dedicated app which brings together trusted and reliable information, informed by national experts providing specialist bladder and bowel care. For more information, visit the CONfidence App website.

Expanding on the research conducted by the Urology team, Professor Marcus Drake explains:

Video Transcript:

My name is Marcus Drake, I am the Professor of Urology and I work at the University of Bristol and Southmead Hospital.

We're very lucky because Urology is a fascinating specialty. It covers the kidneys, the bladder, the prostate, stones in the waterworks, and of course male sexual function.

Now, within Southmead Hospital there are three huge government funded studies. There is the upstream trial – that's looking at the urodynamic testing of men who are considering whether to have prostate surgery. What does the test bring? Is it appropriate to be doing this sort of tests to understand water work symptoms in men?

We're also looking at conventional prostate surgery, compared with a new sort of laser operation. Which is better? They're both good at relieving blockage, but are there differences in the side effects? And this study will tell us exactly that.

And our other huge study is looking at incontinence in men who've had prostate surgery in the past – a minority of men do suffer incontinence, and they may need some sort of surgical treatment. So we're looking at the benefits of a new operation called the male sling in comparison with the more established artificial sphincter, and that we'll be reporting in three years’ time.

Of course we have a whole range of studies but one of the biggest studies ever run in Urology was run from Bristol, and that was the PROTECT study looking at prostate cancer and, specifically, what is the best treatment surgery, radiotherapy, or medications.

Of course we contribute to a whole range of trials run in other centres, and we're extremely active at contributing to a whole range of studies, and I feel that one of the most beneficial aspects of treatment within Southmead is the opportunity to contribute in an area where Southmead really excels and is recognised worldwide.

The Women and Children’s Research Unit conducts research that aims to improve the care of women and children using Obstetrics and Gynaecology services. This includes pre-conception services though to postnatal care.

The Unit collaborates widely with other disciplines and professions, as well as with women and their companions, to develop ground-breaking research and care, for our patients and throughout the NHS.

Here Dr Dimitrios Siassakos, Consultant Senior Lecturer in Obstetrics, and Christy Burden, Senior Lecturer in Obsetrics, share more about the cutting-edge research being conducted by the team:

Video Transcript:

My name is Dimitrios Siassakos, I'm a Consultant Senior Lecturer in Obstetrics, and my name is Christy Burden. I'm a Senior Lecturer in Obstetrics.

Dimitrios: So, with our team, we are leading a large and very comprehensive portfolio of studies, so a large number of studies to improve the outcome of pregnancy so that we can have healthy mothers and healthy babies as well, both from a physical and a psychological point of view.

So for example, we investigated a lot – the management and outcome of women who have bleeding around the time of birth. First of all, can we prevent women from bleeding around the time of birth with the IMOX study, which is one of the largest studies ever to be performed on the topic.

We have completed some studies to see if we can improve communication and teamwork when women do have some bleeding, and soon, with funding from the National Institute of Health Research, we are about to start the COPE study to see what is the best treatment for women who have experienced bleeding around the time of birth.

Another part of our research is focusing on women who have a bad pregnancy outcome, and how we can improve care for them afterwards. So for example, with the insight study with the Lancet stillbirth series, we investigated how to improve care for these women, and now we’re about to start the number of studies to see what are the basic principles so that women can get good care after a bad pregnancy outcome globally, so not just in the UK.

Now within that portfolio of studies, were also investigating how to improve parental involvement, and Christy has some more details.

Christy: So I've been leading on the stearic of the PARENT study, which has been looking at parental involvement in the review process after the death of a baby. And the PARENT study has been looking at developing the process, and then implementing the process, here at North Bristol and also in Manchester.

So the aim of the study is to improve the review process that happens after a baby dies, and this really aligns with the government targets at the moment to try and reduce the number of stillbirths by 50% by 2025. So our research has been really front-leading in this area.

Other research that I've been very much involved in, and we're driving now North Bristol, has been managing women with high-risk pregnancies and maternal medicine complications. And one is that that this is looking at a cute kidney injury in pregnancy.

So this is known to be a real problem outside pregnancy, but in pregnancy we're seeing an increasing problem with acute kidney injury, due to our more complex population, but we don't know how to define this well. So a study that we starting in the summer will be looking at how to define this and looking at you what the incidence is.

Dimitrios: Christy, how do you think all the maternal medicine research fits in with our portfolio?

Christy: I think we've always looked at how to manage women who have complex medical problems and high-risk pregnancies and adverse pregnancy outcomes, so I think it fits in perfectly with what we're trying to do and trying to expand and improve our care for all women. Because, you know, lots of women are having more complex problems in pregnancy now and this will be a problem in the future.