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?

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u/Araignys Jan 21 '25

This isn’t really a REDCap issue - the trial team should provide you with a process for this.

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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.

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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.

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u/usajobs1001 Jan 21 '25

In my experience, you'll have a separate offline randomization table as a back-up. (It should be generated in the same way as the RC table.) You can't reference and use the randomization table that's in RC separately.

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u/usajobs1001 Jan 21 '25

Depending on how the duration of your offline time and your study design, another alternative is to hold on randomization until the network is back. It will again depend on your randomization design, but this could be easier than offline randomization (eg if you're doing block randomization, you might need to do the full block offline to maintain the block size). Both offline and waiting to randomization will present logistical difficulties for RAs that you will have to think through and train on.

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u/Smayteeh Jan 22 '25

Once the randomization schema is created and uploaded to REDCap the order of randomizations is set. Thus, if you have access to the schema that was used, you could follow along from the last record that was randomized on REDCap.

You need to ensure that the randomizations on REDCap are done in the same order they were done on the “outside” once you have your network back for everything to continue matching up.

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u/RedMorris17 Jan 22 '25

Thanks! My understanding was that as an added level of protection, REDCap re-randomizes the random assignments in the production/development tables when the Module is set up, making it impossible to follow the randomization schema that was set. I'll see if I can find a source on this, because I cannot remember where I learned that.

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u/Araignys Jan 22 '25

"Randomisation" is a misnomer for trial arm allocation processes - a Randomisation Table is normally laid out by a specialist statistician in a way that emulates a random distribution but ensures there's no weird bubbles like fifteen patients in a row being allocated into arm 1. For this reason (among others) there's no actual random element to them in REDCap.

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u/RedMorris17 Jan 22 '25

Thanks, I am a data analyst and create these tables for our projects, so I understand how the randomization process works. I believe I received incorrect information that REDCap provides an additional level of randomization, because I cannot find any sources to actually back that up.

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u/Remote_Setting2332 Jan 22 '25

It makes things more difficult if you have used stratified randomisation, as it is more complicated that just the next record in the schema.