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Handling Missed Doses in EC
j
Jozef
on June 21, 2023
Handling Missed Doses in EC
This is a question unrelated to Pinnacle21, and can better be answered in a discussion forum that specializes in SDTM, for example the LinkedIn "SDTM Experts" forum ("only" >3000 members, including all SDTM gurus worldwide): https://www.linkedin.com/groups/2758697/
What is the best way to handle missed doses when the exact dates of the missed doses are unknown?
The CRF is set up to include the date of initial dose from kit, date of last dose from kit, and the number of doses taken. Based on guidance for EC, there should be a record for the interval of time when doses were taken per protocol, then another record for the interval of time when doses were missed and ECOCCUR is set to "N". If I'm given an interval of time, but the # of tablets dosed does not match up with the expected number of tablets to be taken in that time interval, is it okay to still set ECOCCUR to "Y" for that interval of time? Or what is the best way to set this up?