Thank you for a really well presented webinar. I think the Q missed was around repeated need of annotation for the repeat pages.. This of course is not needed and you can indicate a standard text such as 'see annotation page #xx" As an example you may have same exposure pages at 20 different visits. Every unique EX form needs annotation but not every form. I think FDA allows for submission of a crf booklet with unique pages, so they may not be a problem if the aCRF is created as such.
Thank you for a really well presented webinar. I think the Q missed was around repeated need of annotation for the repeat pages.. This of course is not needed and you can indicate a standard text such as 'see annotation page #xx" As an example you may have same exposure pages at 20 different visits. Every unique EX form needs annotation but not every form. I think FDA allows for submission of a crf booklet with unique pages, so they may not be a problem if the aCRF is created as such.
Khalsa, glad you enjoyed the webinar! Thank you for adding this important guidance we missed in our presentation.
how to deal with missing variables ?
Hello? Can a locked data be unlocked for what reasons?
In CDM *