Table 2 Primary themes, subthemes and representative quotes regarding the ‘Education and training’, “Ways of working’, ‘Working with technology’ and ‘Working within regulatory requirements’ primary themes

Education and training

Importance of formal staff training

“Most organisations adhere to…GCP guidelines everybody is referring to the same bible [GCP] I suppose so you can’t stray too far from that” (P3)

“I didn’t get any formal training. I suppose [I’m] just trying to be…I don’t know diligent and as careful as I could be conscientious with all the data in terms of ensuring that it would be [of] quality. I suppose and making sure we were sticking to ethics registration” (P5)

“There isn’t a common basis for the whole lot. I think if you can get something there [education and training] and get people really thinking about it...I think people are yelling out for it” (P4).

“If there’s more information or more training about data monitoring process or data entry education, to clinical research that would be very great.” (P6)

“The only difference would of been…filling people in on the changes and then how that’s been incorporated into the standard operating procedures and their own unique way into each organisations.” (P2)

Learning on the job

“So, you just develop over a period of time with that kind of exposure an understanding and appreciation of how these things [clinical study procedures] go.” (P2)

“I think the most of my training really came about data quality monitoring really came with the audit. So, it wasn’t formal training, but it was a practical training.” (P7)

Ways of working

Responsibility

“we should come up as a team, make sure everybody knows their role that everything’s okay… make sure everything is in place” (P7)

“I think you know if you’ve got clinicians so you know nurses putting in data they’re actually putting in data but they’re not really aware that data could be used in other things, and they don’t they don’t necessarily appreciate the importance of that all fields being completed.” (P4)

Staff engagement

“That’s one very convenient way of engaging with a group of people who perhaps rarely get to play a role in helping put these things together…why don’t you review them and give them some comments” (P2).

“We held regular meetings with staff so to ensure that there was any issue and if there were some yes if they’d obviously obtained an odd score or not response to a question, we could discuss it.” (P5)

“I’ve talked about that with [boss] as I said even with the studies, I’m doing now I will go back to [boss] and say what do you think I should do with this? Um, how do you think I should manage this?” (P3)

Organisational environment

“Whereas now I guess um I’ve moved up [laughs] it’s more the research assistants who are, who keep, keep an eye on it and I’m a little more distanced.” (P5)

Skills and expertise

“People just aren’t intuitive with some things, it’s like you watch one person learn to drive and they’re terrible and others learn to drive and they’re a natural. Ultimately, people learn to drive but they’re at different paces. So, here we just worked out well some people are going to struggle with that instrument so we gave them as much information as we could. We did it visually [included pictures] because that’s much better than reading something so again we made it so it’s nice and quick.” (P1)

Working with technology

Technology induced changes

“I mean we used to in the old days, we would actually have to go to the sites to collate the papers that changed to then the papers would then be sent to us, so it started to get more about currency of data.” (P2)

“So, it’s changed over time as I’m sure other participants would have well and truly told you. Um since the 90s when everything was paper based um you had…paper case report forms in duplicate.” (P3)

Quicker and easier

“Yes, yes everything is there. So, we can just ah with because of everything is online everything from it is kept it is very easy to actually monitor.” (P7)

Investment

“Real time range checking...it wouldn’t prohibit entry of data, but it would certainly require somebody to think about whether the number or the word they just put in was indeed the correct one.” (P2)

Unintended consequences

“Make sure that…all the data had been entered correctly because at one stage you could enter it, but it wouldn’t go in…there was a glitch in it in the program.” (P4)

Working within regulatory requirements

Good clinical practice

“I made sure they actually did it [GCP training] although it was pretty tedious… it was like sticking pins in your eyes, but I actually still think it made people think about exactly what they’re doing and that they’re part of a bigger thing. I think if it was slightly tweaked, I think that, that it would be actually more instructive.” (P4)

“It’s all been very repetitive, and it has all been very sensed around the same sort of rules…everything focuses back on GCP, so everybody keeps looking back to GCP and saying ok what are the requirements…what’s the bare minimal we can get away with.” (P3)

Protocol

“I just follow the template…this was how it first did my, my first protocol” (P7).

“That allowed us to adopt a whole range of more or less protocol defined approaches to all the activities relating to the design, implementation conduct and reporting of clinical trials.” (P2)

Standard operating procedures

“You know and all it takes is…the irony…is you get on the internet, and you do a search for something like a standard operating procedure around a monitoring plan and you can get 10 or 20 different versions of the same thing on the internet and…you look at them with a fine-tooth comb and they all look very similar there’s not a lot of difference between them.” (P3)

“It seems awfully difficult I don’t quite understand why we would want to do any or all of these things [SOPs]. Why can’t we just collect a truck load of data and then analyse it. So, um I think that’s an understandable thing um, but it requires a fair amount of work at the beginning. Particularly for new people.” (P2)

“There was a commercial and non-commercial arm at the [location] and initially we had separate SOPs but then they all got moulded into one another. So, everything that use to be not quite as strict started to be become stricter and I think there was a lot of resentment around that actually in the team, including myself.” (P3)