TV: SDTM Trial Visit Dataset
2 min readJun 9, 2021
Background Story:
So today we will go over the essentials of the Trial Visit dataset, which includes 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.
Key variables :
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 protocolVISITDY: 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:
Ref: