Trial Summary: Difference between PLANSUB and ACTSUB

v Vikramjeet

on September 25, 2017

What is the difference between planned number of subjects and actual number of subjects in Trial Summary domain?

In one of the study I am working on, 30 subjects were planned as per protocol and all of them (30) were screened. Later on, one subject withdrew from study and did not receive the dosing. In such scenario, what should be the actual number of subjects, 29 or 30?

Thanks.

Regards,
Wick

Forums: SDTM

j Jozef

on September 25, 2017

Difference between PLANSUB and ACTSUB

This is clearly defined in the CDISC SDTM controlled terminology (READ IT!): https://www.cancer.gov/research/resources/terminology/cdisc

ACTSUB definition: "Actual number of subjects enrolled; may include subjects who were not randomized".
In your applications, you can also use the RESTful web services to find out: see http://xml4pharmaserver.com/WebServices/index.html
For example, your application may use the following RESTful request: http://www.xml4pharmaserver.com:8080/CDISCCTService/rest/CDISCDefinitionFromCDISCTestCode/ACTSUB/TSPARMCD