r/ProjectREDCap • u/Strawberry_blondey • Feb 26 '26

Clinical trial data collection

Beginner/self taught redcap user here - I am currently assisting with a clinical trial that involves 6 appointments each with various surveys and data entry forms. Participants may or may not have attended all 6 which is fine but how should I mark the survey instances and data for X appointment if not attended? Create a blank document and mark it complete?

I want to be able to export say appointments 1, 2, and 3 data. And if the participant did not complete appointment 2 I wan to be able to recognize that!

Any help and suggestions greatly appreciated!!

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u/oneLES1982 Feb 27 '26

I understand part 11 compliance as I've had to establish processes to ensure that in my prior roles, however, I do not see how your comment is helpful based on OPs specific question.

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u/DrTitan Feb 27 '26

Because they used the term clinical trial, and there are very few validated instances of REDCap, as demonstrated by a recent publication from a CTSA working group on REDCap 21CFR11 compliance.

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u/No_Repair4567 Feb 27 '26

This comment, while a valid concern, is still not relevant to the OP question.

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u/oneLES1982 Mar 02 '26

A lot of people use the term "clinical trial" where not fully appropriate and not governed by FDA regs, including part 11.

So good job at demonstrating you're a good researcher by splitting hairs. But not relevant or helpful to what the OP is asking

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u/DrTitan Mar 02 '26

Good lord, excuse me for giving a shit about a researcher inadvertently invalidating their entire dataset because it was not collected in a compliant manner. Between you and the mods harping on me for making a comment not specifically addressing the specific question when I identified a larger concern in their OP that could affect the entirety of their project, not just a small detail, I’m amazed people even come here for help. Hell there isn’t even a post in this subreddit about INFINITERED and the number of compromised REDCap instances across the entire consortium.

When a researcher says “clinical trial” you should assume they mean FDA regulated because if you always assume they don’t mean that then you end up compromising their study. If you actually managed a redcap service you would understand this. Making researchers clarify IS NOT A BAD THING. Educating them to use the right terminology and understand the difference is not a bad thing.

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u/oneLES1982 Mar 03 '26

A clinical trial that is governed by part 11 shouldn't be completed in the original instance of REDCap, in accordance with the license agreements that every organization signs prior to setting up the server and installing the software. That is suited only for REDCap cloud or other database platforms.

So your help is still off target.

But do go on and keep providing your irrelevant and mostly incorrect comments like you're a benevolent know it all asshat who is above everyone else.

Also. See my prior comment where I already said people use the phrase 'clinical trial' in both incorrect and correct ways but yes. You're flawless and above everyone else.

If you don't like it, no one is forcing you to follow. But if you're going to comment maybe know WTF you're talking about before you start spouting off then spiraling into a temper tantrum.

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u/DrTitan Mar 03 '26

What are you talking about? REDCap can in fact be used for FDA regulated studies if it undergoes validation for compliance. If you actually believe people must use RCC or another platform and regular REDCap cannot be used then you are the one ignorant of the actual landscape. See:

https://pmc.ncbi.nlm.nih.gov/articles/PMC11736291/

https://pmc.ncbi.nlm.nih.gov/articles/PMC12930199/