TV: SDTM Trial Visit Dataset

Background Story:

So today we will go over the essentials of the Trial Visit dataset, which include the planned visit in a trial in the structure of One record per planned Visit per Arm. It will have effects on SV (study visit) domain.

ARMCD: if visits are NOT the same for all ARM, we will populate ARMCD.
*Might have duplicate records.

VISITNUM: Visit Number is a numerical sequence according to protocol, eCRF or codebook.

VISIT: Textual presentation of the numeric visit defined as per protocol

VISITDY: Planned study day of visit is planned by the study protocol in numeric sequence.

TVSTRL: Describes when visit starts, it connects to the sequences of the Element.

TVENRL: Describes when visit ends in relation with the sequence of the elements.
*ex: screening: 4 hrs after start of visit.

Sample Spec


Sample Output:



Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Social media & sharing icons powered by UltimatelySocial
%d bloggers like this: