There were many different activities involved in collecting and managing data in research studies for the research nurses, midwives and allied health professionals (NMAHPs) we spoke to*. These activities varied greatly from one study to the next and depending on the topic being researched. Sometimes these tasks drew on particular professional group skills. Nikki, a research physiotherapist, performed strength and function assessments with patients enrolled on studies. With a background in paediatric nursing, Dawn found it useful that she herself takes the blood samples from child study participants whereas the “adult [research] team don’t do blood samples on children”. Some studies involved seeing a participant just once (possibly the same visit when a patient was approached about a study and consent taken). Others involved several follow-up visits, potentially stretching across many years of research participation.
Louise gave an overview of the data collection activities involved in one study.
Louise gave an overview of the data collection activities involved in one study.
Age at interview: 49
Sex: Female
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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.
Libby described her research delivery role as being “all about gathering good data”.
Libby described her research delivery role as being “all about gathering good data”.
Age at interview: 45
Sex: Female
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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.
Data collection
Although recruiting participants was often seen as a big part of the research delivery role, many pointed out that there was little point to this activity unless high-quality data was then collected from or about participants.
The data collection tasks could include: collating information from medical notes; collecting biological samples (e.g. blood, skin swabs, throat swabs, urine, stool, saliva) and observations; arranging for scans and other tests; assessing participants performing physical exercises; helping participants to complete questionnaires; and interviewing participants.
Some studies involved a lot of data being collected at visits and could be quite intense for participants. In studies with multiple follow-up visits, baseline data was usually collected at the first visit to be compared with data collected at following ones. Other studies required less of the participant’s involvement and time. One study described by Nicky only required participants to give permission for her to extract details from their medical notes. For studies where various scans were required (including MRI and ultrasound), the research NMAHP usually scheduled these on behalf of the patient.
Part of Sian’s role was guiding patients through the data collection tasks, including questionnaires.
Part of Sian’s role was guiding patients through the data collection tasks, including questionnaires.
Age at interview: 48
Sex: Female
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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.
A study that Ella worked on required spit samples from participants. This was a challenge with elderly people, and so an amendment to allow saliva swabs was made.
A study that Ella worked on required spit samples from participants. This was a challenge with elderly people, and so an amendment to allow saliva swabs was made.
Age at interview: 56
Sex: Female
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A major problem we've found is that most of them [elderly participants] do not comprehend the concept of spitting. Because we collect saliva, in a little small sample container. If you tell them to spit, they- they will try but actually most of them, their action is drinking. It's not spitting. So, spitting is-. The brain is not working out how to spit. So that is something we've found with the residents. But we had to ask for swabs instead. Because we began with containers then we realised people actually don't know how to spit. The people who can't spit, we'd swab their mouth and get the saliva that way.
Jisha described the activities in one study which were carried out or arranged by research nurses at follow-up visits.
Jisha described the activities in one study which were carried out or arranged by research nurses at follow-up visits.
Age at interview: 39
Sex: Female
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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.
Several research NMAHPs had themselves processed some of the biological samples collected as part of studies, after being trained how to do so. Learning to spin and freezes bloods, for example, was a skill that some had found interesting. As Alison recalled, “I thought that was amazing at the beginning and I was like in the white lab coat, like a CSI [a television programme – ‘Criminal Scene Investigation’] midwife”. In other situations, samples were sent elsewhere to be processed by other staff or in other locations.
Delivering an intervention
As part of the studies they worked on, some research NMAHPs helped deliver interventions. For those who worked on CTIMP (Clinical Trials of an Investigation Medicinal Product) studies, they might administer the ‘product’ (often a drug) themselves or it might be done by another member of staff. Sometimes it was sufficient for a research NMAHP to be present when a study intervention activity was taking place, such as a surgical procedure or an infusion. The research NMAHP might then also be in charge of monitoring the participant and taking samples and observations as part of their data collection. This could be a lengthy process. As a cancer research nurse, Michael had worked on a study where patients were monitored for 72 hours with frequent blood tests. Other times, it was not necessary or desirable for the research NMAHP to be present or involved in the intervention when it was delivered. For example, Sanjos did not attend the radiotherapy sessions undergone by participants in the studies he worked on.
Michael worked on a lot of phase I (first-in-human) clinical trials which involved administering drugs. He identified primarily as “the nurse, not the research nurse”.
Michael worked on a lot of phase I (first-in-human) clinical trials which involved administering drugs. He identified primarily as “the nurse, not the research nurse”.
Age at interview: 29
Sex: Male
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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-in-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.
In one study, Laura Y had to go into theatre to observe a device being used by a surgeon.
In one study, Laura Y had to go into theatre to observe a device being used by a surgeon.
Age at interview: 39
Sex: Female
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One is a trial called [study name] and this trial basically looks at the possibility of using this device, which is this margin probe, to reduce the number of re-excisions. Yeah. Basically, I have to go to theatre if the patient gets randomised to the probe. Then the doctor will take the- , once they’ve been taking the specimen out to do all the procedures that needs to be doing in theatre, then we'll use this device onto the specimen and check whether there are still positive margins. And then if there are still positive margins, we'll have to take an extra shave.
Although they were not delivering an intervention themselves, some research NMAHPs had to instruct and train other people (including staff and patients) to use devices or to administer study medications. Sugrah had to demonstrate an alarm to study participants (children and young people) and their families. Several research midwives we spoke to had taught pregnant women to use a blood pressure monitor.
Data entry and management
As the records of study activity, site files tended to contain lots of different documents, including the protocol and any amendments. Some research teams had separate staff who entered data, whilst in other places and teams this was an activity done by research NMAHPs. The data entry and management side of research could involve a lot of terms which were unfamiliar to most when they started in research delivery roles. Key examples were: SOPs (Standard Operating Procedures), CRFs (Case Report Forms), and PISs (Participant Information Sheets) or PILs (Participant Information Leaflets). Consent forms were sometimes kept in paper form, other times they were digitalised.
There were lots of different data entry systems used across studies and, as Nicky said, “Some are better than others”. Often the databases were electronic, but paper copies of documents were sometimes kept too. Working in “a very paper-light department”, Imogen and her team mostly used electronic databases which allowed them to easily link up study documents with patients’ electronic records.
Through these systems and other arrangements (for example, sending away biological samples), the data collected would usually then be transferred elsewhere for the next steps of analysis. For James’ studies, the way that data was sent varied considerably – post, fax, email, and via specific websites/applications.
Sandra thought it was helpful to have data support to assist research nurses. She highlighted that entering data in a consistent way was key.
Sandra thought it was helpful to have data support to assist research nurses. She highlighted that entering data in a consistent way was key.
Age at interview: 43
Sex: Female
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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.
Ellen described various forms of data from studies and how she managed them.
Ellen described various forms of data from studies and how she managed them.
Age at interview: 50
Sex: Female
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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.
Although some research NMAHPs found the data input and management side of research “boring”, others enjoyed it and said it fit well with their “organised” personality. Despite different feelings towards this side of research, most people said how important it was to be accurate and thorough. Jo found that the paperwork was “worthwhile but it doesn’t stop it being tedious”. Helen explained that “you are doing paperwork but that paperwork is relevant paperwork. It’s all to do with the patient and it’s valuable what you’re doing, it’s not just tick boxes”.
As part of the process of checking that accurate and up-to-date records were being kept, clinical research studies were usually subject to ongoing queries and monitoring visits. Data teams sometimes asked questions and made requests to complete missing details. At times, these requests could seem petty to research NMAHPs. However, with experience, Michael found it became easier to “get used to what the expectation [was]” and to appreciate that “in research, it does matter”. For some people, monitoring visits were quite an unwelcome occurrence and could make them feel anxious. Others, such as Melanie, found it helpful and it motivated them to keep on top of updating their study files.
Keeping up with data management was an important part of Sugrah’s research activities. These efforts were praised at a recent monitoring visit.
Keeping up with data management was an important part of Sugrah’s research activities. These efforts were praised at a recent monitoring visit.
Age at interview: 48
Sex: Female
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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.
Osi’s first monitoring experience was informative.
Osi’s first monitoring experience was informative.
Age at interview: 27
Sex: Female
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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.
After entering or sending off data, NMAHPs in research delivery roles usually did not have any more involvement in the next stages of research (i.e. in data analysis or dissemination activities) – except potentially helping to close down and archive the study at their site once the research had finished. Some people were happy with their research delivery activities and felt it suited their skills or personality well, but others were keen to have more opportunities to be involved in other research-related activities and some were interested in becoming an independent researcher* so they could lead their own studies (see also the sections on pursuing research via academic qualifications and future career plans).
Responding to and reporting adverse events
In some studies and areas of research, adverse events (AEs) and serious adverse events (SAEs) were very common. AEs and SAEs are untoward effects which relate to, or may relate to, the treatments given in a study. This was particularly important for Michael, who worked on phase I and II cancer trials. In other studies and areas of research, AEs and SAEs were not as frequent or tended to be quite minor. Some research NMAHPs had never had a participant with an AE or SAE, and the prospect of their first one could be quite daunting. Although it was often upsetting, Helen thought that a research NMAHP’s first SAE experience was an important learning curve and gave them preparation for the possibility of more in the future.
The processes of responding to AEs and SAEs was usually documented in the study protocol. These tended to involve notifying various people and departments within certain timeframes and collating data about what had happened (including outcomes). A few people said it was important that research NMAHPs contact the study sponsors if they were at all unsure whether something constituted an AE or not.
Melanie described there being a different approach to Adverse Events (AEs) in an observational study compared to an interventional study involving dermatology patients.
Melanie described there being a different approach to Adverse Events (AEs) in an observational study compared to an interventional study involving dermatology patients.
Age at interview: 43
Sex: Female
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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.
In the physiotherapy research that Karen leads, there can be Adverse Events (AEs) which need to be reported as per the study documentation.
In the physiotherapy research that Karen leads, there can be Adverse Events (AEs) which need to be reported as per the study documentation.
Age at interview: 55
Sex: Female
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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.
Jo tended to hear about Serious Adverse Events (SAEs) quickly, which meant she could make a start on the reporting process.
Jo tended to hear about Serious Adverse Events (SAEs) quickly, which meant she could make a start on the reporting process.
Age at interview: 49
Sex: Female
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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.
Footnotes
*The people interviewed for this website were mostly research NMAHPs (i.e. those employed in a research delivery role). However, we also interviewed some NMAHP researchers (i.e. those leading research as independent researchers). The latter group included people who were undertaking or had completed academic research qualifications, such as PhDs, and many had previously been in (or continued to also be in) research delivery roles. For more information about the distinctions between these roles and the sample of NMAHPs interviewed for this project, please see the Introduction section.
*Many research NMAHPs and NMAHP researchers felt strongly that they continued to be clinical within their research roles. As such, the wording of ‘research’ NMAHPs/staff and ‘clinical’ NMAHPs/staff can be problematic for implying that research is not also clinical activity. Where the wording ‘clinical staff’ is used on the website, we mean for this refer to non-research clinical staff (i.e. those who are not currently employed to carry out research or enrolled to pursue research through an academic qualification).
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