You do work really very independently in research, so, usually have a PI [Principal Investigator] for the study, a Principal Investigator, so but often that Principal Investigator is a clinician, so particularly in, where I work, I mean [cough] the Principal Investigators there, they’re consultants, they’re out you know busy in the clinical area. So really, I would say we kind of pretty much, as nurses, pretty much coordinate and run the studies. So you do have to be able to work very much, you know, take on board a lot of the responsibility. Obviously they’ve got the overall responsibility and you have to, again you have to be able to pick out what are the things, you know, you have to make sure you’re constantly communicating with them to feed everything back, and make sure they’re kind of aware of what’s going on the study and if there’s any issues with patients, then they’re aware of it. But actually, you are making a lot of the decisions. And actually there are a couple, well one study where I’m the PI myself. And I think that’s happening a lot more now, that nurses are becoming PI’s for more studies. So again on that study, you know, it is just me, I’m kind of the person that’s in charge of it, and obviously I’ve got people on my team working on it.

Optimistic, organised, methodical, a good listener, able to get on with people, across a broad spectrum of networks really. Because you’re dealing with, you know, academics and, like yourself, from universities. Or you’re dealing with businesses. And you’re dealing with consultants. You’re trying to motivate consultants. That’s quite challenging, sometimes. It’s just like, I’m, I’m sort of go on the principle of a bull in a china shop, must be it’s my Taurus. But I’m very much of ‘I just need you to do this, is there any chance you could get this done?’ and I’m very much a face to face. If I email, if I don’t get a response, I’m like ‘do you know what, I’ll just go and see them. So I know I’ve always got to put myself out there a little bit more, you know. And you know, within the first few weeks, I very quickly realised they do need- You know, they’re very busy. They’ve massive clinical load. So as regards research, it’s, it’s there, but it, it will always take a second to the clinical needs. Which is obvious. But, so things like reminding them when they need to do the GCP [Good Clinical Practice] training, when they need to do it, sending that reminder. And actually giving them the link to-, you actually, there’s a lot of, you know, really pushing that side of that relationship to support them, to do, to help you do what you need to do.

So, yeah. I think it’s about not always taking no for an answer. Being able to push past that. And, and finding ways to see solutions to problems. So, yeah. A bit more lateral thinking helps.

Yeah, yeah well I think many, many years ago, your Site Initiation Visits, the sponsor would come up to the hospital but I think with cutbacks and you know, perhaps reduced funding and things like that quite a lot of them are done over the telephone now. So we’ve got a telephone Site Initiation Visit tomorrow and we’ll gather together all the research staff who will be involved in the study. Myself I’ll be there, it’ll be the Principal Investigator and the co-investigators and we’re also getting some of the CNS’s [Clinical Nurse Specialists], because they’re actually gonna be delivering the CTIMP [Clinical Trials of an Investigational Medicinal Product]. So it will be a dial-in with the slides and it’s just a great opportunity to go through the protocol and ask all those questions that you’re just not quite sure about and how you’re going to do the training and, you know, who’s gonna be trained, you know, are they gonna need GCP [Good Clinical Practice] training, how are you gonna run the study, where are you gonna store the drug. Pharmacy aren’t attending tomorrow but they’re attending a separate Site Initiation Visit.

So an ideal Site Initiation Visit would be that I would invite as many people as possible because I think if you get engagement at the very start with the CNS’s as well and support services if they’re ever able to come, then that would be great because they understand about the study form the very beginning. But in reality that doesn’t always happen, that everyone gets involved, but I do, I would invite everybody who I thought might want to be there. And then the ideal would be that they would go through the protocol at the very beginning and everybody was there and ask any questions and that might take about an hour and then at that point all the clinical team, the non-research staff can all go because they don’t wanna go through the Case Report Forms and the electronic CRF and, you know, all the sample handling and things, so that would be-, you know, we’d probably carry for about another hour and then yeah that would be, but that’s a great opp-, I take loads and loads of notes and then from that I start working out the work instructions for the study and how we’re gonna run the study.

In practice.

So obviously the PI, the Principal Investigator, always work very closely with them. Make sure that they know what’s going on, where we’re at with the study. Have there been any changes? Do, you know we have regular meetings just to check in and see where we’re at, cos obviously they’re responsible for the study, I’m not, I’m responsible for my patients. They’re responsible for the study. So, they need to know everything that’s going on, and making sure that they’re aware. Working with the study teams, it’s really important to have really clear conversations, and if you’re not sure about something ask, I’ve never met a study team that have gone, Phew what are you asking that for? No, they always, always willing to help, I’ve never had any problems with my study teams. I don’t know whether I’ve just been lucky or whether that’s the case for everybody but they, we’re here to help them do their study, and they can’t get their results without us, and actually if we’ve got results but we don’t give it to them nothing’s going to happen with it. So again, it’s that partnership working, but yeah always go back to them and ask them questions, if I’ve got any concerns. There are study teams that are very new to research and actually I probably know a lot more about research than they do, so sometimes if I read something and I think, Oh I’m not really sure that that’s quite right, I’ll go back to them and say, it’s just a query, I’ve worked on studies before and this bit doesn’t really make sense to me. Can you explain to me how that works? Or, Are you considering changing that bit at all?

Asking the question cos sometimes it changes and especially in palliative care, the time frames nearly always have to be extended because it takes longer to achieve the results than we’re expecting. And that happens in lots of studies not just in palliative care but because we don’t know, and you’re kind of thinking, Oh yeah, can do this, this and this, and because they take a timeline, but patients don’t conform to timelines. They conform to whatever path they’re on, so it depends where you intercept with them and is that going to work. So just keeping really clear, if you’re having any problems going back to the study team and say, The patients are saying this, this is the reason I’m not- so screening logs, and keeping that information as to why people say no’, can be just as important as why they say yes.

And particularly I think that you know a lot of the study centres I mean it’s not the same that the PI’s [Principal Investigators] do know obviously but a lot of the study centres they don’t have that idea of what it actually is or how a hospital operates and sometimes I’ll look and, you know, and think oh well why can’t you just get that information, you know, and things don’t all, you know. Things don’t always happen that way and things will always be different to how they anticipate that they will be because of, you know, different reasons than the clinical environment. And that as well it’s about them understanding that-, you understanding what they want but they also understand, they have to understand how, how you’re gonna get that and that might not fit into every box, every time [laughs].

So typically you’ll have data teams, who are administrative staff who will go through your notes scrupulously and ask you, Why did you not write the date here You scored that out and didn’t sign it And there can on occasions be a little bit of tension when you’re new to research, because you get really busy and you’re clinically very busy with often very unwell patients, so the last thing you’re thinking at that time is to-, when you score something out to sign it the correct way that the data team want it. And then the next day when they’ve gone through your notes, they come and grab you and say, Can you fix this? Can you correct this You know, This is illegible, and you haven’t written this, can you clarify that And you get to the point where you’re like, Do you know what, I’m so busy, I’ve got the patient, just leave me alone, it doesn’t matter But of course, in research it does matter. But you learn that as you go along, the more experience you get with the clinical trial, you know that it’s easier in the long run to document it well at the time, and that becomes second nature after a couple of months, you get used to what the expectation is, cos it is different from a ward setting in terms of documentation. So you pick that up and then it becomes fine. The data team are fantastic. I don’t envy them in many respects because they trawl through doctors writing, which is notoriously difficult to read on occasion. And they’re the ones who really will make sure your data is exact and correct, and so they’re a real big support.

I’m sure I’m not the only person to say this but I find the e-mails and things that I get from the people who are co-coordinating, managing whatever there’s loads of them all seem to be doing the same thing who seem to spend a lot of time asking Ginny, you know, how many dah dah dah have you done this month?’ or going Oh well done’ and I find it very patronising and also really irritating having that all the time.

Because I’m quite self-motivated I think so I would do that anyway so I’ll, I’ll recruit people because I want to and because I’m interested in doing that, I don’t find it very helpful having somebody kind of doing targets like that.

With my team, I will always tell them-, when there is an SIV [Site Initiation Visit] coming up- even if they are not the main lead nurse, I invite everyone to attend that. Because it will be better for them to know what’s going on in their team. Rather than ‘oh, I don’t know that study at all. If someone comes and ask, or maybe a patient relative sees a leaflet and asks, What is that trial? it would be really foolish to say, Sorry, I don’t know. But I will tell them- even if you don’t know the in-depth of the study and each steps, just to have a brief idea of what the study’s all about. And also, they will be on the delegation log, attending all the trainings. For example, if someone is on leave or someone has gone on sick leave, there is always a buddy nurse to look after that study. So the study won’t be struggling and the participants also won’t be struggling. So, that’s how I manage my team [laughs]. And it, it is working well. Because if someone is struggling and really busy one day, there is another person who is not the lead nurse, can, you know, come in and help them to recruit that patient. And do the steps, yeah.

And I think the team were amazing. Because everybody just said they had no-, you know, they just said, Don’t expect anything, just be a sponge, just see as much as you can, ask what you can, if you don’t understand just ask. And they had no expectation to put pressure on me for any length of time, until you felt ready to do it really.

So I think it was- and that was difficult, because in a ward, you know, we’re not quite so patient when a new nurse comes on the ward [laughs]. Because you’re like ‘come on, really need you to go and do that admission, and we need that admission done really efficiently and really quickly because there’s another one needs doing. And that, that- there wasn’t that. That certainly was not the atmosphere. It was a very supportive, and just you know, Just take as long as you need, there’s no, you know, You’ve just got to, you learn this as you do it really.

Well I mean now if it’s a biggish study and you want it supported by one of the clinical trials unit, you are following acres of paperwork, of SOP’s [Standard Operating Procedures] and this, and that and the other, and you know there’s no avoiding it, you’ve just got to suck it up and do it really. I don’t think it’s actually made the research any better than what we did before when we had so much less, but you know it’s, things are different nowadays, I mean governance matters, you’ve just got to follow it.

You know it is, it is paralysingly slow sometimes, and ethics, well actually if you get, if you ever get to an ethics committee it’s fine, it’s getting it through R&D [Research & Development], checking it, changing it, changing it, and it’s very much sometimes about one person’s slant on things versus another. I mean it drives me demented when you have to put things to R&D, and they’ve changed the wording of your letter. You know, you know, for god’s sake, you know, I’ve been doing this for 30 years, I know how to write a letter to a patient. You may have phrased it differently, but what I did was not unintelligible. But, but yeah, it’s just one of the irritants of doing research.

It is quite, quite bureaucratic.