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Deriving visits in SV
Deriving visits in SV
As you don't seem to get an answer ...
The best place for such SDTM questions is on the "LinkedIn SDTM Experts" forum: https://www.linkedin.com/groups/2758697/
All the major SDTM gurus are there - they are not here ...
Personally, yes, I would also assign these "Pre-screening". There are no enumerations for the visit name.
Also for the "EPOCH", you could use "PRE-SCREENING"."EPOCH" is enumerated, but the codelist is extensible.
Jozef
Thank you for your response…
Thank you for your response Jozef! As per you comment, if some visit (day= -100) is in 'SCREENING' folder in raw data we are allowed to assign this VISIT as "Pre-screening". :)
screening versus prescreening
SDTM is about data categorization. So it is your own decision how to categorize such data.
Personally, I would map such a -100 day as "PRESCREENING", and in the define.xml, describe your algorithm for the categoriazation (MethodOID on ItemRef, and MethodDef), even when the data point was marked as "screening" on the CRF or in the database.
One of the reasons for this decision, as if you map it to SDTM "SCREENING" this would mean a protocol deviation, for which you need to create a record in the DV dataset. As this protocol deviation is avoidable, I would indeed map it to "PRESCREENING".
Also do not forget the extend the CodeList for "EPOCH" for this.
For further details, please contact me by e-mail.
P.S. This is not a formal or informal P21 answer: I am not working for P21.
The time window for the screening visits is defined as study days [-60 - -1] in the protocol. However, there are some procedures that occurred before day -60 and/or before informed consent but these observations have visit=’Screening’ in raw data. Are we allowed to derive such visits as Pre-screening in SDTM?