The main part of the study that I’m working on at the moment is a follow-up visit. So that takes quite a lot of sort of organising, contacting the patient, arranging the visit, you know, to see a two-year old, a lot of parents work now, so it’s organising all that, a bit of admin involved. And then the visit itself takes around an hour, there’s a large questionnaire, we collect a saliva sample from the child, and we do a skin prick test. And, and then there’s a lot of, quite a lot of data to collect then that’s all to input onto a computer system. So that’s one study.

I think it, to me it means things like just on a very simple level, checking that I’ve got all the numbers right. So, if I’m going through a questionnaire that has a score attached to it, it’s checking the numbers at the end so that you’ve, you know on a very basic level just got your maths right. But also making sure that the way that you conduct that questionnaire is consistent as far as it can be across the board, so it’s, it’s as replicable as it can be each time. So that the responses that you get aren’t skewed by the environment that they’re given in.

So, I mean, so basically it, one are maths, double check, have a second checker to check, but also there’s the more sort of soft, the soft side of it, so was it noisy outside the room when the patient was doing this test? Has it had an effect on, on how they performed? You know, did the patient break down in tears and you had to comfort them and stop, and then you know, making sure that if you’re doing something simple like a walk test, that has you know that you start at the same place with everyone and you finish at the same place with everyone. And standardised ways of timing when you start, when you finish. You know those sorts of things about the data that you gather, if you don’t get it you know as clean as you can then the intricacies and the details about what you’re measuring is lost and I think the devil’s in the detail always, so you know you might as well not do it if you’re not going to make sure that you’ve got it clean and tidy.

So once they’ve consented then we’ll start working through what the study’s asking them to engage in, so whatever that be so we’d work through the CRF [Case Report Form] or the data capture record depending what study and what sort of terminology. And just work our way through that and just sort of reassuring the patient as we go along and enabling them time to ask questions as well that’s really important and checking that they’re still kind of with you on the journey and that they understand the what you’re doing and why you’re asking things. Because sometimes you will ask them questions and, as you know, some questionnaires kind of repeat themselves but in a different way and they don’t always understand well why is it like that and it’s just sort of explaining, well its asked in a different way because they want it form a different angle, so that they don’t get frustrated with it really because some of the studies can be quite lengthy. So, and then giving them breaks perhaps not always doing it in one visit, perhaps doing it over two or three even if you’ve got somebody who’s in their 90’s and they’re a little bit frail or not feeling so well today it’s just gauging it for them really and their needs, yeah.

So, with the [study name] trial I was talking about in the beginning, that is- , we do follow-ups when they go home, on discharge day. Plus day 28, we bring them back to the hospital because that’s the time they finish their IMP [Investigational Medicinal Product]. So we need all the remaining IMP back, so they will have to come and do the blood again. And we will have to centrifuge that blood, and we need to collect the urine. So either we go to the patient if it is really-, the patients are complex, like very disabled, we have been done- doing that before. But nowadays most of the patient come to the hospital and we do that process in the hospital. The next time when we see, it will be three month follow-up. That is the time normally the speciality nurses will be seeing the patient, after a subarachnoid haemorrhage discharge. Or the consultant will be meeting them. So we fit around with that follow-up. Then the next follow-up will be at six months time. They will have to do an MRI. So we arrange that MRI, and the consultant see them. So we fit around with that consultant, follow-up, and arrange the MRI all together. And we just go to the clinic and see them.

I am a nurse, and my job is to make sure that my patients are well supported, are well cared for, that I have considered their whole life, given holistic care. And it just so happens that a clinical trial is the vehicle to do that. This is what the patient wants to have at that time, so I’m going to deliver that clinical trial and give them that drug but I’m going to be the nurse who’s doing it. So I’m the nurse, not the research nurse.

So, we do phase 1s, and some phase 2 trials, but mostly phase 1s.

So for me, that’s my preference, in the sense that I’m very much a nurse and my role within the clinical trial and with the patient is very much nursing focussed. It has some challenges in the sense of you’re giving a first-human drug, you’re giving a drug that’s never been used before, so we know nothing about it, so you can’t almost anticipate what reactions are going to be like. So you draw on all your clinical assessment skills as a nurse in that-, in that viewpoint. It’s very regimented, it’s very observational, you want to pick up on any little change that happens and document that clearly. But the benefit of that is that as someone who likes being a nurse and likes being with people, you get as much as the-, the patient-health professional contact in an early phase clinical trial, which you might not get in the later phase trials.

There probably are not enough data managers, data support people. We’ve often said, actually, it’s a different skill set to a nursing skill set but it’s an essential part of the role if you want the research to be valid. So, although some people are one finger typers, it could take quite a long time to do. So, I think investing in data people is really important, and actually the network has just appointed five new people to do that, so that hopefully we can focus more on the nursing aspects and they can input the data for us to save time. But they’ll probably do some basic research studies as well, where perhaps they don’t need to take any bloods, so they don’t need any clinical skills, but it’s just questionnaires and they can take in information and do that as well. I think it’s acknowledging that there’s different skills for different parts of the team, and yes, one person can do all of those things but are they doing it to the best of their ability, are we using the best use of their time and resources? Possibly not. So I think having someone who can input your data is great. I think one of the things we’ve found out in my first study was we did appoint another research nurse to work with us at one point, so there were three of us, and we suddenly realised when we were all inputting the data in differently, so yeah we had to then transfer, change the, you know, use find and search and change the information. So, some of us were putting Yes and No, and some of the people were putting 0 or 1 so 0 was no, and 1 was yes. And then, so we had to go back and change all that information so that we were all doing the same. And things like where we stored the samples in the freezer, what order do we put them in the box? So, some of us were going like this, and some of us were going like this, and it seems like nothing, but actually when you’re trying to find something later on that order is important. So then having standardised practises of working, if you’re working with multiple people, agree even the simplest thing. This is how we’re doing it. So, we’re all doing it the same. So later on, when I want to find the sample I’ll know that it’s going to be here, and it’s easier to map what, what we’re doing so.

They’re nearly always inputted electronically onto a secure website. Samples are often frozen and you have to arrange collection by courier. By, in bulk. It’s not per sample. I know some trials do, but ours- ours haven’t. Scans? That’s a- radiology’s a big [laughs], a big issue with stroke. Because obviously they nearly always want the brain scans. And then they want MRI. Often they want MRI brain scans because they give them more information. But they are- we don’t do them routinely. Radiology are always so busy. Anyway. So they’ve done them. So, sometimes we upload them electronically. Then they have to be anonymised and it’s all very complicated. Apparently. Yeah, we used to fax a lot but we’re not allowed now. So we scan and email, and anonymise. So yeah, you’re kind of, you’re kind of doing your work twice with the paperwork. Because you collect the data on paper and then you input the data [laugh] electronically.

One or two trials have said you only need to- they don’t really- some- they vary. Some say keep the paper, some say just-, it’s an electronic trial, just do it all electronically. But that doesn’t work, to my mind, with an MHRA inspection in the future, when the electronic data’s not accessible [laugh]. So, we just keep the paper.

So we would do that, so basically your day was gone by the time you’ve finished approaching, recruiting, consenting patients, recruiting them, setting them all up and then putting them onto the database, recruitment logs, everything.

So, the days were very busy, writing in the medical notes, so that was it was basically from the start of the study it was start as you mean to go on. So, we never left, we did not leave anything Oh we’ll do it later, it was like anything you could get done, get it done there and then. So, it’s done, completed and move on. And if anything for any reason could not be done we would leave a note on our handover sheet for the next person to pick up. So, it worked really well.

Recently we had a monitoring visit and we were told our team effort [with the Trial Master File (TMF)] was beautiful. Considering we had over 1,200 patients, we have all our consent forms filed in order and everything the filing has been like I said we started as we meant to go on, and it has been very clearly documented that folders are clear, what’s in what. We don’t keep consent forms in the TMF but we have file notes for any document that should be in there that is not in there, stating where it is, and why. So that worked really well. We had an excellent system.

Yeah. So at first I was very-, the first one I’ve had was very, very scary cos I-, it was for a commercial study as well which is probably one of the hardest ones, and we were the only Trust in the UK to have actually opened up that-, that study at that point in time. So I was just like ‘oh my gosh,’ and I was very new to research so everything was just all very-, it was a massive study and I thought ‘oh. And it was nothing to do with midwifery either, it was to do with like women’s health which technically, I wasn’t trained in you could say cos I was always-, I was never a nurse to start off with. However, it was very helpful. I would love for them all to come as often as she does, although she gives me a massive list to like complete. You know that everything is like up to date and nothing’s going to shock you, and like where you’ve got to sort out the problem that happened two years ago, you know that within two months or whenever she does come, it’s regular updates which is helpful. It is a bit, as I said, nerve-wracking, someone checking your work. But I think I’ve learnt through my Masters that you want everyone to check your work [laughs]; you’re going just give it to everyone to have a read.

It depends what the study is I should say. So, we’ve got an observational study where we’re following patients up who are on particular systemic drugs for their psoriasis, and an adverse event is reported to us in-. So, we follow them up and we want to know what’s happened to them in the previous six months, so an adverse event can be any time in that previous six months. So, those aren’t necessarily urgent because they’ve been dealt with by the appropriate medical team at the time, and we’re just capturing that data, and that’s captured on a paper CRF [Case Report Form] and then uploaded onto the database. And depending on what it is, depends on how much information we will try and capture. If it was hospitalisation they’ll want to know how many nights and IV [intravenous] antibiotics, and all that sort of thing. So, we try and capture all that information. Adverse events for drug studies, I’m sure you know need to be reported much more expediently. So, we’ve had the odd -, fortunately, we haven’t had anything awful where patients have been really poorly, but we have had the odd few events that we’ve wanted to report quickly. And I guess it’s just about -, it’s knowing -, it’s knowing who to report to before you need to do it, so I try and make sure that we all know whether it’s a level one or a level two study, and do we just need to report to the sponsor or do we need to report to sponsor and to R&D as well.

And I’ve found that instead of trying to collect all the information before you let anybody know, it’s better actually, as soon as you know when you’ve got a sketchy amount of information, just let the sponsor know and just let R&D [Research & Development] know, and at least they’re aware. And then you’ve reported it within the 24 hours or whatever that particular study says, and then you can collect the rest of the data afterwards, still within whatever specified timeframe it happens to be.

But I think when you first look at those adverse event forms, or especially the SAE [Serious Adverse Events] forms, they’re, you know, X amount of pages long, and you think ‘how am I going to get all of this data right now?’ But I think, I think there’s an understanding that get what you can and then sort of work, work on the rest of it afterwards. Sometimes it does mean that you have to prioritise because if you’ve got to get that information over to them within 24 hours, and you do need to work with a consultant cos they’ve got to have input into whatever it happened to be and ‘was it related to the drug?’ and all of that sort of thing. So, there is some, some -, there are some times when you just need to sort of prioritise that over everything else. And that has happened but yeh, not too -, not too frequently, thankfully.

Yeah, I mean it happens. And usually there’s a very clear protocol for what you do to, you know, so you just follow the protocol. They, they’re not catastrophic, it’s not like drug trials where you could, we’re not talking sort of a Northwick Park [a drug trial scandal in 2006] type of event, they’re usually increased pain or people who’ve fallen or, you know, that type of thing. But I mean I think there’s always a very, very clear protocol for how they are reported, managed, it’s usually like getting the patient back in to see one of the clinical team, and, you know, and mostly they are-, they’re not directly related to something that you’ve been doing [as part of the research]. So, I mean it’s rare that you get an adverse event because they’ve been doing-, I don’t know, baseline assessment and they’ve tripped up while they’ve been doing it and broken their leg or something. So, I think they’re fairly, but I think, I think they’re, if your protocol is right and your SOP’s [Standard Operating Procedures] are right, I think they’re easy to deal with.

Yes I usually hear about serious adverse events very quickly particularly with patients who are on the renal unit because the renal unit staff are extremely helpful and they always know which patients from which trials and they usually give me a ring and say so and so is, has been in A&E [Accident & Emergency], so and so has been admitted and then I chase that up and then report that as an SAE [Serious Adverse Event] within the, you know, within the required timeframe. Either pop and see them when they’re in A&E or pop and see them when they’re on the ward, have a look through the notes see what’s going on with them and then I can you know, compile a report to start with and then I usually finish and complete on discharge when the whole you know, when the whole story is unfolded and we know what’s what. So there’s, there’s, there’s one trial particularly at the moment that I’m doing which is a pivotal trial which requires a lot of information regarding serious adverse events and as a patient they tend to have quite, you know, quite a lot going on for them because they’ve got lots of co-morbidities and so other, you know they do get admitted to hospital fairly regularly.