Following a close of the trial at NBT, it is necessary to archive all trial related documentation to ensure that all study documentation is:

• Stored correctly and confidentiality maintained.
• Not passed on without the appropriate consent.
• Accessed in-line with Trust policies and procedures.
• Only used for the defined purpose.

This archiving process also ensures:

• Patient safety in using and recording information
• Up-to-date information is stored
• Staff awareness of responsibilities and accountability
• Information is accessible when required

Storage of personal data is subject to the Data Protection Act 1998 and, in clinical trials, the applicable elements of the UK Clinical Trial Regulations.

Standard Operating Procedure ISOP IO3 describes the procedure for the archiving of all study documents on ALL research studies that are sponsored by or hosted by North Bristol NHS Trust. The length of time for archiving is dependent upon each individual protocol and/or guidance from the commercial sponsor.

The process for safety reporting varies depending on whether or not the research is a ctIMP and on the procedures of the Sponsor of the research.

This general process should be followed in all research:

• RECORD the event may be recorded on the patient's medical notes, a Case Report Form (CRF) or on a Safety Reporting Form provided by the Sponsor.
• ASSESS an assessment should be undertaken by the Chief or Principal Investigator to evaluate seriousness, causality, intensity and expectedness. 
• REPORT based on the conclusion from the previous step, the event should be reported on the CRF and/or SAE form as appropriate and within the timescales required.

There are a number of other issues to consider at each stage and the timescales depend on the nature of the event – for example a fatal Suspected Unexpected Serious Adverse Reactions (SUSAR) must be reported and signed by the PI within 24 hours to the Sponsor, followed up in writing within 48 hours, and reported to the MHRA and REC no later than 7 days after the Sponsor becomes aware of the reaction.

The NBT policy is to monitor 100% of all ctIMPs and Device investigations for which NBT is the sponsor, at least annually.

If your study is sponsored by a commercial company then you must expect more regular monitoring and allow time for this in your work schedule.

As a host organisation, NBT aims to monitor 25% of ctIMPs and Device Investigations for which NBT is not the Sponsor. In addition, NBT will monitor any NBT sponsored project which reports a Suspected Unexpected Serious Adverse Reaction (SUSAR) and monitor any commercial project withdrawn prematurely for reasons, other than safety, unless recently monitored by the Sponsor.

Audit and monitoring visits may take place at any time, although adequate notice will be given. It is important that the project documentation is well-maintained and accessible at all times.

It is important to let your sponsor know once your first patient is recruited to allow for monitoring after the first participant visit. This can help to smooth a document pathway and ensure that data is collected in accordance with GCP & ICH guidelines.

Monitors/auditors will need access to participant medical records, and this must be provided by the research team. The sponsor will give you notice which participant notes they require. It is the responsibility of the entire research team to ensure that medical notes are correctly traced on CERNER.

Providing treatments now - Pioneering for the future.

BrAMS was established in December 2008 at Frenchay Hospital. The centre is the first of its kind in the UK providing dedicated research, treatment and therapy for those with multiple sclerosis in the South West.

Following the closure of Frenchay Hospital in May 2014, the BrAMS service transferred to Southmead Hospital Bristol where the multi-disciplinary team continue to provide first class clinical care and up to date clinical research where patients can access a wide range of treatments.

BrAMS offers a unique service, offering support, information, clinical treatment and therapy and research to people across Bristol and the South West.

Over 4,000 people visit the unit each year.

The unit offers: 

• Expert, unrivalled clinical knowledge in multiple sclerosis and associated neurological conditions.
• A dedicated specialist MS nurse team offering a range of specialist nurse led clinics, a telephone helpline services and invaluable support to MS patients their families and carers.
• A specialist physiotherapist service offering instant access to information, treatment, exercise, balance rehabilitation including vestibular rehabilitation, spasticity reviews, mobility aids, orthotics provision and a monthly joint orthotic clinic.
• An intravenous suite allowing access to daycase IV steroids, which are often used to treat patients in times of relapse or those with severe spasticity.

To access any of these services, (if not already known to the unit) we require a letter of referral from your GP.

Please note we are unable to provide non-evidence based therapies such as hyper-baric oxygen, acupuncture, homeopathic or herbal remedies.

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“Well over 20 years ago, I lost the sight in my left eye and after initially going to my local eye hospital I was passed on to a Neurologist. After a series of tests I was diagnosed with MS. I was only 24. This was a shock as I knew someone who had the disease and she used a wheelchair. My wife and I were expecting our first child so I was worried how my MS was going to affect me and my family. My family were all very supportive and together we found out more about the disease. Although I continued to work as an engineer for another 7 years, I became more and more tired; I now know this to be fatigue.

Six years after being diagnosed I started to get pins and needles in my left arm and leg, which later became numb. Every year following this I had one or two relapses, each time something different happened and eventually I had difficulty lifting my left leg and so I used a walking stick. A few years later, my right leg became affected and later a tremor developed in my left arm. Of course this was annoying, but I am right handed and so found different ways to do some things. I have hand controls on my car and so can still drive, which of course still gives me independence.

I eventually had to stop working as an engineer and so wanted to find something to keep me occupied. Five years ago I was introduced to a team of Neurological Consultant Doctors who told me of their idea to create an MS centre of excellence in Bristol, where people could receive treatment for the disease and be involved in new drug trials under a specialist team of MS doctors, nurses and a physiotherapist. They asked if I would help them raise funds for the unit and so became their Voluntary Fundraising Manager in 2007.

My condition is now secondary progressive and so I cannot do quite as much as I used to, but I try to go to the BrAMS Centre each day, just for a few hours, depending on how I feel. I have received treatment at the centre and I feel that because I have been able to continue to still work, albeit part time, this has helped me to stay positive and help others with the disease.”

• Multiple Sclerosis (MS) is the most common disabling neurological disease of young adults in the UK.
• Over 100,000 people in the UK have MS and it effects over 2,000,000 more.
• Approximately 120 people per 100,000 in England have the disease
• It is not considered a terminal illness and it is not contagious.
• Most people are diagnosed with MS in their 20s and 30s affecting more women than men.
• Multiple sclerosis is not inherited, but family members do have a slightly higher risk of developing MS.
• Although we can not predict exactly how MS will affect each person many people with MS live as long as anyone else.
• In the Bristol and Avon region, the population of patients with Multiple Sclerosis is in the order of over 2,000
• In the Bristol and Avon area alone, over 100 new cases of Multiple Sclerosis will develop each year
• Of these, over 90 are likely to present with a relapsing-remitting course, but approximately 10 will exhibit a course of steady progression of disability from the onset (Primary Progressive Multiple Sclerosis)

Disease modifying drugs are not a cure for MS, but they can reduce the frequency and severity of relapses. If you experience relapses these drugs may help, but they are not effective for primary progressive MS.

It can be frustrating if treatments aren't suitable for you or they don't work as well as you like. Lots of people with MS find it useful to actively manage their health.

Depending on what symptoms you have, there are different ways to manage their impact on your life.

There are 3 main types of MS:

1. relapsing remitting MS
2. primary progressive MS
3. secondary progressive MS

Relapsing remitting MS is the most common type of MS, affecting around 85 per cent of those diagnosed. It means that symptoms appear (a relapse), and then fade away, either partially or completely.

Primary progressive MS affects about 10 to 15 per cent of people diagnosed with MS. Symptoms gradually get worse over time, rather than appearing as sudden attacks (relapses).

Secondary progressive MS is a stage of MS which can come after relapsing remitting MS. It means there is a sustained build up of disability, completely independent of any relapses.

It is not uncommon for a diagnosis to take several months, and frustratingly it can take even longer. A range of other possible causes need to be explored and many different tests need to be carried out.

What should I do if I think I have MS?

Most people who experience unexplained symptoms won't have MS. However, if you're concerned that you may have MS, your GP should be your first port of call.

If your symptoms are not too severe, your GP may not do anything immediately. However, if you have another period of symptoms, your GP should refer you to a neurologist. If the neurologist thinks that you might have MS, they will normally give you a number of tests.

Many people going through this process describe themselves as being in limbo, since doctors are often reluctant to confirm a diagnosis until they are 100% certain. 

MS is an autoimmune disease. The body’s immune system attacks its own tissue thinking it’s a foreign body. In the case of MS, the immune system attacks myelin in the brain and spinal cord therefore sending incorrect messages from your brain. Initially, symptoms commonly occur as separate “attacks” or relapses, each lasting a few weeks and resolving, not always completely spontaneously.

Symptoms vary greatly in terms of severity as everyone is different but those with MS may experience:

• fatigue
• anxiety and depression
• loss of bladder and bowel control
• issues surrounding cognition, concentration and memory
• sensory impairment including heat sensitivity, pain and pins and needles
• motoneurone issues including dropped foot, muscle weakness, tremor, spasms and spasticity
• loss of vision including blurred and double vision
• problems surrounding speech and swallowing
• a lack of balance, dizziness, vertigo, visual problems and poor visuo-spatial perception
• a variety of sexual issues