Tracking clinical trial administration through JIRA

[H A]

Hi, has anyone used JIRA for tracking clinical trials through startup, enrolment, allocation, and then tracking timepoints, deviations, and RGO amendments as the study progresses?

I have done some research and found this - https://www.slideshare.net/GoAtlassian/how-we-managed-a-multiyear-multidrug-clinical-trial 

Currently I have set up tracking trials at our public institution. We do not upload patient data, only planned events and study updates for cohort closure et cetera. I think there is a better way to use workflows though, as currently my workflows look like 'In progress - > pending HREC - > pending RGO - > open to recruitment -> on hold -> closed to recruitment' and I would be interested in hearing other people's mapping of study events with workflows.

I know it's possible, and want to hear if anyone else has been doing this in the background!

[Nirmani Kalakheti]

Hi H A,

Are you an admin of Jira or one of the stake holders? I have not seen anything related to Clinical Trial as an admin of Jira. But I can ask around to find out and will let you know if I have an update. 

[H A]

I'm not a Jira admin, I just 'administrate' a company owned project with a team of users, our medical oncology trials team. I'm a study coordinator and database coordinator, so I'm usually on the lookout for audit-logged ways to track trial administration. We don't use a CTMS to manage trials but Jira is starting to fill that need for us.

[Jessi Smith]

Hi HA!

I'm one of the speakers of the talk that you linked here. I've had some reach out to talk about how we use Jira, and you may have been one of those people but if not feel free to get in touch!

[Pedro Chacón]

Hello @Jessi Smith I'm a study coordinator for clinical trials and I've just seen you slideshare presentation! Is there a chance that I can get in touch with you for certain specific questions I currently have for the implementation of these software for the clinical trial environment? 

Thank you!

[Aaron Horsey]

Hey! I've been wondering about this too and the slides you found from Jessi look very interesting. I'm interested to see if Jira can be a useful tool in the generation and upkeep of study documentation and study issue tracking rather than the granular detail of study visits (which was pretty impressive to see implemented!). Any thoughts?

[H A]

Hi Aaron, so it's been a year since I made the original post, and since then I've developed and am currently administrating an internal trials-tracker project in JIRA for our oncology trials unit.  We use it pretty much how you describe - study tracking for approvals, document version control, pushing cohort/recruitment updates to the whole study team at the same time - the collaborative aspect has been very useful for us. What it takes to make it work is being embedded directly in the trials team, helping them with their day-to-day tasks to get a real sense of what is actually useful to track. We have a digital eISF management outside of our JIRA project, so we try to consolidate temporal study points (large and small) into JIRA as it's most useful when it can be harnessed to grab chronological data for trials, in my opinion. 

[Aaron Horsey]

Thanks! It sounds so sensible. I was surprised that there don't seem to be too many use-case examples of Jira in clinical trials management - at least not publicly visible! For the trial tracking (doc version control, recruitment tracking, etc.) part of your setup, did you have to use many plug-ins/add-ons and are there any particular steps you'd recommend looking into?

[H A]

I'm sort of old-school in that I like to use as few third-party add-ins as possible, and have the entire system under as much of my own control as I can. Mostly because I want to easily be able to export, migrate, troubleshoot my own work without having weird updates to plugins and et cetera getting in the way. It's also easier to build instantly without waiting for institutional permissions at the higher level for requesting add-ins (I work in public govt hospital). I probably could have set up our workflows and some automations and timepoints more easily if I did use any add-ons or plugins, but I've got enough database experience to basically know what I can build to capture what I want the tedious by-hand way. It has been worth it, I think, to do this by hand as it's engaged our whole team to be active collaborators and editors of the 'issues' as they move through the workflow - in my experience people tend to disengage with overly-automated systems because they trust them to work smoothly (I don't!).

[Prabhu Palanisamy _Onward_]

HI @H AI recently published an article that you may find it useful

https://community.atlassian.com/t5/Marketplace-Apps-Integrations/Using-JSM-for-Clinical-Research-Professionals-CRP-Onboarding/ba-p/2489978

[Pedro Chacón]

Hi @H A , I'm a study coordinator for clinical trials and I've just read your post and seen your comments and suggestions. This seems pretty interesting, and I would like to get in with you for certain specific questions I currently have for the implementation of these software for our environment.

[Amin Ghalamchi]

Hi @Pedro Chacón , 

thanks for your message. As we are doing exactly use cases like this 
and we can provide customized solutions for your case, feel free to 
send me an email to amin@fluidwork.io. 

We have also specialized colleagues for clinical trials and we can 
apply Jira processes as described above. 

cheers,

Amin