Participation databases [Design Issues]

posted by ElMaestro  – Denmark, 2019-12-31 21:21 (1575 d 10:35 ago) – Posting: # 21045
Views: 7,120

Hi Hötzi, and all,

❝ Everyone should be happy. Question: Where should such a system be located? At the EMA?


This would be an interesting discussion. A legal discussion, probably?


❝ BTW, I like ANVISA’s system. The database is run by the agency and volunteers are blocked from participation in another study for six months. No fret, no pain.


This is much like Ovis and its siblings. A central database from which you get a single piece of info back and the submission is a fingerprint: Blocked or not (=can participate or not). It gives no personal info, no photo, no government ID, no birth date etc. It simply says yes or no given a "unique" identifier (such as the fingerprint), full stop.
In India, from the top of my head the general quarantine is 90days but the CRO can specify it to be longer.

However....

What do you do with the info? How do you record it?

Let us say you are a CRO and you are screening and enrolling subjects. Where would you record whether ID00012345 (CRO ID, not official ID) is blocked? A checkbox on a CRF? A screenshot from Ovis etc documenting time and block/no-block? Great eh?

Then switch hats and assume you are the inspector or auditor.
  1. Can you ask the database if the CRO queried the guy having a fingerprint matching that of ID00012345? No, you can't.
  2. Can you ask the database if the CRO had any contact to it on the day of screening? No, you can't (=you actually do not know if the databse was online that day. Or if the CRO was, power outages and all. Now don't give me the usual spiel about UPS and stuff :-)).
  3. Can you audit the provider of OVIS, CTVS to check records at their end etc? No, you can't.
  4. Can you somehow enter a discussion of false positive and false negative finger print matches? No, you can't. I have had my fair share of false ID's with CRO finger print scanners when we use a 'naïve' finger, i.e. a finger which the reader has never seen.
  5. Can you somehow get hold of the subject and ask if she/he remembers anything about a fingerprint? As an inspector, possibly, but you may be in Ahmedabad and the volunteer in Bangalore. Phone home and tell your boss you will need two extra weeks and a budget for an interpreter. Good luck with that.
  6. Can you get actual info on 00012345's participation at other CROs? No, absolutely zero chance.

So, in the study you are looking at 2 of every 5 having lower than normal HB and HTC, 3 of 5 have at least one of them low, all of them are cleared by the PI as NCS, and you only have a checkbox stationg the database check has been done, or you have a screenshot. Both the screenshot option and the checkbox-on-CRF option provide wide open opportunities for tampering. So you still sit there with an inkling.... could 00012345 have been cross-participating?


§2.10: "All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification."

§2.13: "Systems with procedures that assure the quality of every aspect of the trial should be implemented."

Go figure....
—
Pass or fail!
ElMaestro

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