Blind monitors or greedy sponsors? [GxP / QC / QA]

posted by ElMaestro  – Denmark, 2022-05-25 10:11 (192 d 20:43 ago) – Posting: # 23016
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Hi Hötzi, all,

❝ Given that, were monitors of the other sponsors :blind: or just greedy?

these CROs were accused of practices that hardly anyone can see if monitoring is done in the classical fashion. I have been deeply involved in CROs doing "the switch", and none of them left any trace on source and/or they left no trace on source that would be easy to spot (this consideration includes spreadsheets for those who heard such rumors).

Next, monitors are relatively low on the corporate ladder. They do not decide what they are supposed to look into. They do not write their own SOPs or give much direction. Therefore, don't blame it on monitors. Blind monitors are not an issue, I think, but no monitors are. It isn't unusual that sponsor skip monitoring altogether. Like some of our mutual friends in the US do when using this CRO.

I would much rather point towards something much more basic. There is no guideline that specifically says you have to monitor or when (ICH E6 has a vague wording on this part), and there is no guideline that says what exactly to look for and if you've been working with CRO X for Y years and never had an issue then why would you consider "the switch" a manifest risk that requires activity? Mind you, you already convinced me (really!), but the task is to convince the decision-makers who know little about these operations, but who know how to read legal stuff.

Finally, "the switch" is perhaps much easier to see at a stage when monitoring is done. This is not a monitoring thing, basically.

DD: Well what would you look for? It was not until 2021 that someone actually showed that the switch can be seen with software, but this requires that such software is written and available along with data.

Pass or fail!

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