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.
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.
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.
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.
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.
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.
*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).