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:

 

Ref:

https://www.slideshare.net/ankurpandit/trial-design-domains

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