4 Radnor Corporate Center
Suite 350
Radnor, PA 19087
+1 (888) 507-2270
–ENTPT, how should we define a reference time point(in general cases)
Julie AnnHi Kevin, There are a few…
Hi Kevin,
There are a few conventions and rules related to relative timing variables themselves, such as --ENRTPT/--ENTPT shouldn't be populated if a value for --ENDTC is present for the record and --ENTPT must appear in the dataset with the variable --ENRTPT, but there are no rules regarding the value present for --ENTPT. However, it is correct that this variable should be populated with a value that is meaningful for the study. Together, this means that, technically, the value for the <Date of last edit> would be allowable to be used, as in, there is not a conformance rule that would be triggered by using this value for --ENTPT, however, if this date value is reflective of any possible updates within the EDC system, then it may become meaningless in terms of the record in SDTM, and subsequently, the analysis. The example you gave in your question demonstrates this nicely.
Instead, --ENTPT should be populated with a value that is descriptive of when the end of the event, intervention, or finding/finding about took place. For example, for log forms where events or interventions may be marked as ongoing, it is common to see the Date of Visit or Visit value used as the value that populates --ENTPT so that the record contains --ENRTPT=ONGOING and --ENTPT=[Date of last visit] or [Last Visit Name]. This lets a reviewer know that the event or intervention was still ongoing as of the date the participant's last visit happened.
I hope this helps!
Yes, Agree with you. The…
Yes, Agree with you. The derivation of variables should be meaningful for study analysis, study milestone related or defined for analysis purpose. We can not just take the "Any timing.." content from IG as unrestricted timepoint, especially for a modify date from EDC system.
As for SDTM (–ENTPT), how should we define a reference time point? Is there a specify rule about these variables. Likes AEENTPT.
SDTM IG 3.4 section 4.4.7 says “The variables --STRTPT and --ENRTPT contain values similar to --STRF and --ENRF, but may be anchored with any timing description or date/time value expressed in the respective --STTPT and --ENTPT variables, and are not limited to the study reference period.”
I am not sure about the meaning of “Any timing…”, per my previous understanding, this should be study related milestone and should be useful for analysis. But can we use the <Date of last edit >, the system of variable of EDC?
If we use the EDC modify date, the datasets would be strange, since date are inconsistent. For example, subject can be Screening Failed on 2022-07-07 and then divorced from study definitely. But there is a edc modify date on 2022-08-08, it seems wired.
I find every details in IG and PharmaSUG Papers, but there is no explanation about this part. How should we understand the ‘Any timing..’ in IG. Wish for your advice.
Attached Files