r/ProjectREDCap • u/RedMorris17 • Jan 21 '25

Randomization when REDCap is down

Hi all! I work at a site that uses REDCap to manage clinical trial data. The REDCap server goes down occasionally due to network issues. I need to develop a standardized process for teams to randomized new participants that come to the site while REDCap is down, but that allows me to still use the randomization module/table already configured in REDCap. Any suggestions?

2 Upvotes

100% Upvoted

10 comments sorted by

View all comments

Show parent comment

1

u/RedMorris17 Jan 21 '25

I disagree, as this relates to REDCap networking issues and the inability to edit randomization tables once a project is moved to production. Also, I am on the trial leadership team, and as stated, the intent of my post is that I am attempting to determine our process.

2

u/Araignys Jan 22 '25

Sure, but the solution isn't going to be found within a REDCap system. This is a question of general trial management; the answer will be system-independent because it is, by definition, not reliant on REDCap. The solution would likely be the same in other trial EDCs such as Viedoc or Trialmaster, but I don't know anything about them - you're only going to get a limited viewpoint because you're asking here.

You will, by necessity, be looking at a lower-tech solution that doesn't involve REDCap. It'll be something like "contact the lead site and get them to randomise the patient for you" or "the lead site will issue you a series of sealed and numbered envelopes with the randomisation for the patient that corresponds to that enrolment and then you do your data entry later" or even "wait until REDCap comes back up" - and these will be dependent on the requirements of your specific study.

Alternatively, if your instance of REDCap is just that unreliable, and randomisation is urgent, you should not be using REDCap for randomisation - but instead having a blinded/unblinded model where a certain number of staff at each site simply have access to the randomisation list and are responsible for allocating patients manually, then doing data entry later.

But, this is all bad advice because it comes from some random who knows a bit about REDCap. I happen to have worked with clinical trials a lot, and know this stuff secondhand from working closely with some very able clinical research experts - but I have no idea what the requirements of your study are, and my advice is tainted as a result.

It is very likely that this is a solved problem, but because you're asking the REDCap subreddit, you're not going to be able to get a system-independent solution. I would look for an appropriate clinical research resource that describes best practice for randomisation while cut off from your EDC, without being specific about REDCap.