How to create sdtm specifications

What is Sdtm specification?

SDTM provides a standard way to format and organize data. It is becoming one of the required standard to submit data to FDA because of its capability to improve the regulatory review and approval process. It is widely used in pharmaceutical companies. Writing SDTM specifications is the first step of SDTM development.

What is Sdtm mapping?

One of the most challenging programming problems in a clinical trial involves SDTM mapping. That is mapping datasets from a non-CDISC structure to the CDISC SDTM structure. In order for clinical trial data to be analyzed and accepted by regulatory reviewers, CDISC standards must be adhered to.

What is the difference between Sdtm and ADaM?

While SDTM is used to create and map collected data from raw sources, ADaM is all about creating data that’s ready for analysis. SDTM is ALWAYS the source of the ADaM data.

What is the difference between Ex and EC in Sdtm?

EC should reflect collected treatment details and missed dose information. EX should represent actual treatment administrations represented in the protocol-specified unit.

What is Rfxstdtc in Sdtm?

RFXSTDTC is indeed the date/time of first study drug/treatment exposure.

What is the difference between Ex and EC?


First, as the name states, EC is the exposure information as collected. EX is the exposure in protocol- specified units.

What is difference between Rfstdtc and Rfxstdtc?

RFXSTDTC & RFXENDTC are the new variable added in SDTM IGv3. 2. Earlier RFSTDTC or RFENDTC are used for the start date/time of exposure and end date/time of exposure, but now there are specific variable introduced RFXSTDTC and RFXENDTC for the same.

Is domain in Sdtm?

Background. SDTM is built around the concept of observations collected about subjects who participated in a clinical study. Identifier variables, which identify the study, subject of the observation, the domain, and the sequence number of the record.

How do you derive Rfpendtc?

From this definition, a common idea of derivation is to find out the value of all date/time variables of a subject in each domain dataset in the database, and then the maximum of these values is the subject’s RFPENDTC. Repeat this process for other subjects then RFPENDTC for all subjects will be obtained.

What is Sdtm in SAS?

SDTM stands for Standard data Tabulation Model, which defines a standard structure for study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and medicine Administration (FDA) 2.

How do I create a Sdtm dataset in SAS?

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  1. We will make use of this data set (along with the other CDM data sets) to create the SDTM DM data set.
  2. Go to the tab named DM, which lists the definition of each of the variables in the SDTM DM data set:
  3. Each variable has a clear definition.
  4. The program above creates the SDTM DM data set.​

What are ADaM datasets?

ADaM defines dataset and metadata standards that support: efficient generation, replication, and review of clinical trial statistical analyses, and. traceability among analysis results, analysis data, and data represented in the Study Data Tabulation Model (SDTM).

How is study day calculated in SAS?

Studyday calculation ( –DY Variable in SDTM)

The Study Day value is incremented by 1 for each date following RFSTDTC. Dates prior to RFSTDTC are decremented by 1, with the date preceding RFSTDTC designated as Study Day -1 (there is no Study Day 0).