Hi Sai,
I think that Option 1 is a better choice.
However, keep in mind that SDTM standard is not designed to handle data errors or compliance issues.
Kind Regards,
Sergiy
Hi,
We currently have a scenario where the drug is dispensed to the subject for a period which patient will log in the diary and will be entered in the database during the next onsite visit.
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Planned Dose on CRF = 1 tablet every day
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Actual Dose on CRF is aggregate of drug intake during entire period of 1 month = 30 TABLETS (1 Tablet= 10 mg (protocol specified unit))
→ Is the representation of ECDOSE below is appropriate? (FYI: ECDOSTOT we are assigning it based on expected intake and this field is not collected on CRF. Can we assign it?)
→ Which way of representation of EXDOSE is appropriate in SDTM as we using EC domain to derive EX domain (when ECDOSE is presented as above (30 TABLETS))? Are we in any violation of EC/EX rules?
Thanks!
Sai.