I would like to know if EXDUR can be used for instances where the IMP is applied via a patch test method to the skin of a subject and removed again, for example, after 2 days to assess some scores. The IMP is given once, however, the patch is removed 2 days later. So my EXSTDTC and EXENDTC are basically the same (because the IMP is given only once and not twice) , however, the IMP duration is 2 days.
According to SDTMIG 3.1.3 the EXDUR should only be used if specifically collected in CRF (which it is not in my case). Therefore, please let me know if you have any idea where to put this information.
Pinnacle 21 uses cookies to make our site easier for you to use. By continuing to use this website, you agree to our use of cookies. For more info visit our Privacy Policy.
Dear all,
I would like to know if EXDUR can be used for instances where the IMP is applied via a patch test method to the skin of a subject and removed again, for example, after 2 days to assess some scores. The IMP is given once, however, the patch is removed 2 days later. So my EXSTDTC and EXENDTC are basically the same (because the IMP is given only once and not twice) , however, the IMP duration is 2 days.
According to SDTMIG 3.1.3 the EXDUR should only be used if specifically collected in CRF (which it is not in my case). Therefore, please let me know if you have any idea where to put this information.
Thanks!