FDA Business Rules Excel - Pending Q response

[JozefAerts]

In the FDA Business Rules Excel, In the column "Condition (success)" I see in some cases "pending Q reponse".
What does this mean? Does it mean we should not start working on it, e.g. as the rule is not clean and FDA response is needed?

[eljanssens]

Hi Jozef. These are the trial design rules. I didn't get to these yet so you can ignore them for now. I think this 'pending Q response' was added by Marcelina and is referring to FDA responses indeed.

[aniemes]

Hi @eljanssens!

I was wondering about the Excel spreadsheet as well. I see most of the rules are in green, but some are in orange and some red. What do the different colors mean? Also, some are lined through. Does this mean they are not to be implemented?

[eljanssens]

Hi @aniemes. Thanks for asking. Maybe I forgot to mention this during one of the office hours. I did a clean up of the FDA business rules spreadsheet so that messages are aligned, wording is the same etc. The ones that are fully reviewed and updated are marked in green in the first column. There are however some tough cookies that I'm not completely done with (orange or red). But I think we have enough green to ensure continuation of rule development right now.