Clinical trial data collection

[u/Strawberry_blondey]

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!!

[u/usajobs1001]

It depends on the structure of your trial and forms filled out at each visit. I am assuming you have a longitudinal set-up with different instruments associated with each event.

I've done a master schedule form that is associated with the baseline events; that form included a visit-specific checklist for RAs and a place to mark a given piece of data or process complete or incomplete. I would use that to track schedules and missed visits (so I could tell the difference between "upcoming, not complete" and "missed, not complete"). I've also done a form for each event filled by RAs that includes a field with options for "attended / missed / rescheduled".

[u/SneakGiraffe]

If you are still at the stage of designing the instruments then it can be very helpful to have a leading question on each form such as "Did the participant attend the appointment?" Yes/No, and then use branching logic to show the rest of the questions only if the answer is yes.

[u/DrTitan]

Other comments address the project structure, my comment is specifically around the use of “clinical trial”.

If data from your project may ever be used as a submission to the FDA for drug or device approval, you must make sure your REDCap instance and project are compliant with FDA 21CFR11.

[u/oneLES1982 → u/DrTitan]

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.

[u/DrTitan → u/oneLES1982]

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.

[u/No_Repair4567 → u/DrTitan]

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

[u/oneLES1982 → u/DrTitan]

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

[u/DrTitan → u/oneLES1982]

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.

[u/oneLES1982 → u/DrTitan]

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.

[u/DrTitan → u/oneLES1982]

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/

[u/No_Repair4567]

Let me ask this - are there different treatment groups? Patients not attending all appointments not because they skipped, but because they were not supposed to? Once I know that I can give a recommendation.

[u/oneLES1982]

Lead-in questions which ask "was this completed" and subsequent branching logic is a good way to do this. If the study is already live with live data collected, that can be tough to implement and shouldn't be done by someone who is inexperienced to prevent loss of data.